The Skeptics Guide to Emergency Medicine

Date: August 12, 2025 Article: FDA Approved and Ineffective by Jeanne Lenzer and Shannon Brownlee. June 5, 2025. The Lever. Jeanne Lenzer Guest Skeptic: Jeanne Lenzer is a long-time medical investigative journalist and returning SGEM guest. Her previous work, including the book The Danger Within Us, explored how conflicts of interest and weak evidence can endanger patient care. In this new project with The Lever, Jeanne analyzes how the FDA approves drugs that often don’t meet basic efficacy standards. I think many people assume that if a treatment is FDA-approved, surely it must work. However, people may be shocked to find out about the FDA’s drug approval process and how ineffective or harmful medications make it to market. Most patients and doctors have no idea that the FDA has quietly flipped the drug approval process on its head by putting most drugs on the market before they are shown to be safe or effective, with the promise that they will do those studies after they are on the market. Studies have shown that once a drug is on the market, patients do not want to enter or remain in clinical trials because they are convinced they’re being deprived of a proven treatment, and failure to enroll sufficient patients is one reason postmarket studies are delayed or never conducted. Once a drug is on the market, the FDA can require postmarket testing, but the due dates are often set so many years in the future that the patent will have run out. Take the controversial new Alzheimer’s drug, Leqembi, which causes brain bleeds, swelling and death. The manufacturer is required to conduct safety studies and report annually to the FDA.  However, neither the FDA nor the company will release the safety data until the final report is due. This will be in 2036, 13 years after it’s been on the market. This can be considered a guaranteed win for Pharma and a bad deal for patients. The FDA has fallen so low that the agency introduced a new term, “dangling approvals” for drugs approved before clinical benefit was proved and then allowed to remain on the market even after the post-marketing studies fail. Richard Pazdur, head of oncology at the FDA, defended the agency’s refusal to order certain cancer drugs off the market even after their post-market studies failed, saying “A failed trial, doesn’t mean a failed drug.” Well, true and true, but the idea is that drugs were supposed to be proven to work before they go on the market, not after. And with Pazdur’s and the FDA’s reasoning, any bad drug could remain on the market forever. And a few have. A two-year investigation by Lenzer and Brownlee found 429 FDA approvals (2013–2022) where the majority of drugs were authorized on inadequate evidence of effectiveness, with heavy reliance on surrogate outcomes, frequent lack of replication, and slow/absent confirmatory trials. The highlighted real-world harm and cost and call for regulators and clinicians to re-center on patient-oriented outcomes (POO) before widespread adoption. The article gives a few stories about FDA-approved drugs that turned out to cause harm without any benefit. One example was the drug Elmiron: Elmiron (pentosan polysulfate sodium) was approved in 1996 by the FDA for interstitial cystitis (chronic bladder pain) FDA approval was given without solid evidence of effectiveness FDA allowed approval on the condition that a follow-up study be done to confirm efficacy The follow-up study took 18 years to complete and showed no benefit over placebo Despite this, Elmiron remained on the market Not just a lack of benefit, but there were reported cases of harm Elmiron was associated with cases of a rare eye disease called pigmentary maculopathy that resulted in vision loss or blindness. It was also associated with severe colitis and dozens of deaths Bottom line is a drug with no proven benefit and significant harms stayed on the market for nearly 30 years A cautionary tale of systemic FDA failure to protect patients There were other examples in the articles: Avastin (bevacizumab): Initially approved for metastatic breast cancer via progression-free survival (PFS) surrogate; later trials failed to show survival benefit; approval was withdrawn for that indication, but surrogate-based oncology approvals have continued apace. Copiktra (duvelisib): Approved on surrogates; subsequent data suggested earlier death vs comparator and serious harms; FDA restrictions only years later. ProAmatine (midodrine): Repeatedly rejected; ultimately approved under Subpart H with promised post-market evidence that never convincingly materialized. Special Guest Skeptic: Dr. Jerome Hoffman. He is a longtime friend of the SGEM, a mentor and a true thought leader in evidence-based medicine (EBM). Dr. Hoffman has critically appraised stroke studies, challenged the tPA (alteplase) hype, and now serves as the analytical lead behind this FDA investigation. Four Questions for Jeanne & Jerry Listen to the podcast to hear their answers to these and other questions. What are the four standards the FDA claims to use when approving drugs? Control Group: Patients taking the drug were compared to a control group that was given a placebo or a comparator drug. Replication: At least two “well-controlled” trials showed the drug was effective. Blinding (Masking): Subjects in the studies and the doctors who cared for them don’t know which patients are on the drug and which are in the control group. Clinical Endpoint: The studies measured the drug’s effect on patients’ survival or function rather than a surrogate measure. Of the hundreds of drugs analyzed, how many meet all four?  Therefore, 44% of these drugs met two or fewer of the FDA's four core criteria for approval. 73% percent of drugs approved by the FDA did not meet the agency’s four foundational standards required to show they work as expected. More than half of drug approvals were based on preliminary data rather than sound evidence that patients had fewer symptoms, improved function, or lived longer. Fifty-five of the 429 drugs approved met only one of the four standards needed to show that a drug is safe and effective; 39 drugs met none of them. Which category of drugs seems to be the worst offender, and why? Oncology was the standout concern: of 123 cancer drugs, 2.4% (3/123) met all four criteria; 29 met none. 81% of cancer approvals used surrogates (progression-free survival) rather than overall survival. What changes are needed? Do we fix the FDA, or start from scratch? Key Take Home Points: Even giving them the benefit of the doubt, nearly ¾ of drugs failed to meet all four of the standards. Cancer drugs are among the worst, often approved on flimsy surrogate endpoints like tumour shrinkage. Elmiron, for example, stayed on the market for nearly 30 years despite never being shown to work and causing blindness in some patients. The FDA is funded largely by industry through user fees, leading to deep structural conflicts of interest. Clinicians must remain skeptical, dig deeper into the evidence, and resist the assumption that “FDA-approved” means “safe and effective.”  SGEM Bottom Line: Being approved by the FDA doesn’t mean a drug is effective or even better than a placebo. All we can conclude is that the FDA approved the drug. We need to be skeptical, look at the primary evidence, and be willing to question the system. People may not know, but the SGEM tagline came from a lecture given by Dr. Hoffman. He concluded the lecture by encouraging the audience to be skeptical, even of him.  Remember to be skeptical of anything you learn, even if you heard it on the Skeptics’ Guide to Emergency Medicine. Other SGEM Episodes: SGEM Xtra: The Danger Within Us SGEM Xtra: No Retreat, No Surrender - Thrombolysis for Acute Ischemic Stroke SGEM Xtra: Jerome Hoffman - Legend of Emergency Medicine

Reference: Jessen et al. Pharmacological interventions for the acute treatment of hyperkalaemia: A systematic review and meta-analysis. Resuscitation 2025 Date: August 6, 2025 Guest Skeptic: William Toon is a paramedic who, this past May achieved over 50 years of continuous EMS certification. His professional path has taken him from front-line paramedic to national presenter, expert witness, flight medic, EMS program director, and senior training executive with a doctorate in Higher Education. Case: A 65-year-old patient presents to the emergency department (ED) with general weakness, mild abdominal cramping, and nausea over the past 12 hours. The patient has poorly controlled type 2 diabetes, heart failure with reduced ejection fraction, and chronic kidney disease stage 4 on hemodialysis. The patient missed their last dialysis appointment two days ago. The patient takes several medications for kidney disease and blood pressure, including a potassium-sparing diuretic. His ECG shows peaked T-waves. Stat chemistry reveals a serum potassium of 6.5 mmol/L. He is not yet oliguric and is hemodynamically stable. The team must initiate pharmacologic treatment immediately while preparing for possible escalation to dialysis. Background: Hyperkalemia is a potentially life-threatening electrolyte abnormality frequently encountered in the ED. It’s common in patients with chronic kidney disease, diabetes, or those on renin-angiotensin-aldosterone system (RAAS) inhibitors. While treatments like insulin, beta-agonists, and calcium gluconate are well-known, the comparative efficacy and safety of pharmacologic agents used to rapidly reduce serum potassium remain uncertain. Clinicians must balance rapid action with safety when choosing treatment for hyperkalemia. Understanding which pharmacologic interventions work best and how quickly they act is vital to optimizing care. Unfortunately, much of the existing data on hyperkalemia treatment is derived from small or methodologically limited trials. Clinical Question: What is the effectiveness of pharmacological interventions in the acute treatment of hyperkalemia compared to standard care, placebo, or other interventions in adults? Reference: Jessen et al. Pharmacological interventions for the acute treatment of hyperkalaemia: A systematic review and meta-analysis. Resuscitation 2025 Population: Adult patients with hyperkalemia (typically defined as serum potassium ≥5.0 mmol/L). Studies included varied populations such as those with CKD, dialysis patients, and acutely ill inpatients. Exclusions: Patients under 18 and those receiving non-pharmacologic interventions (dialysis) were excluded. Intervention: Any acute pharmacological intervention to mitigate the harmful effects of hyperkalemia or to lower potassium levels. Comparison: Placebo, standard care, or head-to-head comparisons of other pharmacologic interventions. Outcome: Primary Outcome: Change in serum potassium from baseline at specific time points (1, 2, 4, and 6 hours). Secondary Outcomes: Proportion of patients achieving normokalaemia, adverse events (hypoglycaemia), need for rescue therapy (dialysis), and all-cause mortality. Type of study: Systematic review and meta-analysis Authors’ Conclusions: “Evidence supports treatment with insulin in combination with glucose, inhaled or intravenous salbutamol, or the combination. No evidence supporting a clinical effect of calcium or bicarbonate for hyperkalaemia was identified.” Quality Checklist for Therapeutic Systematic Reviews: The clinical question is sensible and answerable. Yes The search for studies was detailed and exhaustive. Yes The primary studies were of high methodological quality. No The assessment of studies were reproducible. Yes The outcomes were clinically relevant. Yes There was low statistical heterogeneity for the primary outcomes. No The treatment effect was large enough and precise enough to be clinically significant. Yes Who funded the trial? No financial support was provided for the study. Did the authors declare any conflicts of interest? No relevant conflicts of interest disclosed. Results: Studies included adult patients with hyperkalemia from EDs, inpatient wards, and dialysis units. Ages ranged widely, with a predominance of patients with chronic kidney disease (CKD) and cardiovascular comorbidities. Key Result: Sodium zirconium cyclosilicate and insulin-glucose regimens were most effective in lowering serum potassium within four hours, while other agents had limited short-term impact. Primary Outcome: At four hours, insulin-glucose reduced potassium by an average of 0.8 mmol/L, and sodium zirconium cyclosilicate by 0.67 mmol/L. SPS (sodium polystyrene sulfonate) and patiromer showed smaller and delayed effects. Secondary Outcomes: Hypoglycemia occurred in 17% of insulin-treated patients. Dialysis was needed in 6.2%. Mortality rates were not significantly different among treatment groups. Substantial Clinical and Methodological Heterogeneity: One of the most important limitations of this SRMA was the considerable heterogeneity in study design, patient populations, baseline potassium levels, and definitions of hyperkalemia. For example, some studies included only CKD patients, while others focused on acutely ill hospitalized individuals or dialysis-dependent populations. Furthermore, the timing of outcome measurements varied, making direct comparisons difficult. This heterogeneity undermines the consistency of pooled estimates and limits the applicability of the findings to specific ED populations. Risk of Bias in Primary Studies: Many of the included trials had methodological weaknesses, including poor allocation concealment, lack of masking, and incomplete outcome data. Several studies did not clearly describe their randomization procedures. These issues increase the risk of performance and detection bias, especially when subjective outcomes or clinician decisions like the need for dialysis. The GRADE framework used by the authors appropriately rated much of the evidence as “low” or “very low” certainty for key comparisons. These biases raise doubts about the internal validity of the SRMA conclusions and highlight the need for better-quality trials in this domain. Co-Interventions and Protocol Variability: A recurring issue was the use of multiple simultaneous treatments across arms, such as combining insulin, beta-agonists, and calcium gluconate in varying doses and sequences. This practice, while clinically realistic and pragmatic, muddled the attribution of treatment effect to any single agent. In real-world ED settings, polytherapy is common, but in research, this confounds the estimation of the independent effectiveness of each drug. Without stratified analyses that control for such co-interventions, it is difficult to know whether observed reductions in potassium were due to one agent or the combination of agents. This limits the SRMA’s ability to inform what might be the best therapeutic option. Sample Sizes and Few Events: Despite including over 100 studies, many of the comparisons within the SRMA were based on small individual trials with limited numbers of participants and few outcome events. As an example, data on adverse effects like hypoglycemia or need for dialysis were inconsistently reported and often underpowered to detect differences. The lack of data leads to wide confidence intervals and imprecise point estimates, which weaken the clinical significance and reproducibility of the findings. Lack of Focus on ED-Specific Contexts: Though the SRMA is highly relevant to emergency medicine, only a minority of included studies were conducted in ED settings. Many trials were hospital-based or conducted in specialized units like nephrology wards, and some included stable outpatient populations. This matters because ED patients often present with more acute symptoms, comorbidities, and a need for rapid intervention. Additionally, drug availability and workflow constraints in the ED differ from other settings. Therefore, the external validity of the findings to ED practice is limited, and the SRMA may not fully capture the nuances of time-sensitive decision-making in the ED environment. Comment on Authors’ Conclusion Compared to SGEM Conclusion: We agree with the authors’ conclusions but would emphasize the limited certainty and highlight the need for better patient-oriented outcome data before changing practice broadly.  SGEM Bottom Line: Insulin-glucose remains a reliable first-line agent for acute hyperkalemia management, but newer agents like sodium zirconium cyclosilicate show promise and may play a complementary role. Case Resolution: You administer 10 units of IV insulin with an amp of D50 and initiate inhaled albuterol. You consult nephrology and start sodium zirconium cyclosilicate, which is available in your ED. Repeat potassium at four hours drops to 5.4 mmol/L. No dialysis is needed. William Toon Clinical Application: This SRMA reaffirms insulin-glucose as the first-line treatment for hyperkalemia in the ED. It also supports adding beta-agonists when needed, de-emphasizing bicarbonate and sodium polystyrene sulfonate in acute settings, and suggests newer agents like SZC for future integration into your ED’s hyperkalemia protocol. However, it does not mean we should not use calcium gluconate or chloride in patients with hyperkalemia. These agents are not meant to lower potassium levels, and it would be inappropriate to have expected them to do so. The SRMA did not demonstrate a patient-oriented outcome (POO) of benefits. We should interpret the findings cautiously. The absence of evidence of benefit is not the same as evidence of no benefit. Therefore, calcium should not be abandoned for the acute treatment of hyperkalemia solely based on this SRMA.

Date: August 11, 2025 Dr. Gillian Schmitz Guest Skeptic: Dr. Gillian Schmitz is a board-certified Emergency Physician practicing at The Naval Medical Center in San Diego. She is also a former President of the American College of Emergency Physicians (ACEP). This SGEM Xtra is inspired by the 1992 film A League of Their Own. Unlike our previous pop culture references like Buffy the Vampire Slayer, Star Trek, Batman, Top Gun, Ted Lasso and Mission: Impossible, this story is based on real events. The All-American Girls Professional Baseball League (AAGPBL) was created in 1943 and lasted until 1954. This league gave over 600 women a chance to play pro baseball. For the SGEMers who may not have seen this movie, here is a summary. A League of Their Own (1992) is a sports drama directed by Penny Marshall that tells the fictionalized story of the real-life All-American Girls Professional Baseball League. It was formed during World War II when many male baseball players were serving overseas. The film follows sisters Dottie Hinson and Kit Keller as they join the Rockford Peaches and navigate the challenges of playing professional baseball in a male-dominated society. With a blend of humour, heart, and historical insight, the film highlights themes of gender roles, perseverance, and the lasting bonds formed through sport. Top 5 Themes from “A League of Their Own” As chosen and interpreted by Dr. Gillian Schmitz. Listen to the SEGM podcast to hear her full description of what the quotes mean to her. “I don’t have ball players. I have girls.” – Jimmy Dugan This quote reflects how society has historically minimized women’s capabilities in professional arenas. Emergency medicine, like baseball in the 1940s, has not always welcomed women without skepticism. Concerns about femininity, perception, and acceptance parallel the gender biases faced by women in emergency medicine leadership today. Even ‘proper’ women had concerns, expressing their worries about the ‘masculinization’ of these pioneer female athletes. Sound familiar? We have done several shows on the SGEM illustrating the gender inequity in the house of medicine. SGEM#352: Amendment – Addressing Gender Inequities in Academic Emergency Medicine SGEM Xtra: From EBM to FBM – Gender Equity in the House of Medicine SGEM Xtra: Unbreak My Heart – Women and Cardiovascular Disease SGEM#248: She Works Hard for the Money – Time’s Up in Healthcare SGEM Xtra: Money, Money, Money It’s A Rich Man’s World – In the House of Medicine SGEM Xtra: I’m in a FIX State of Mind “Why should you go? To say for once you actually did something… something special.” – Kit to Dottie This line speaks to the deep calling many women in emergency medicine feel. It reminds us of the early emergency medicine pioneers who were often told they were wasting their time. Yet they pressed forward, driven by the belief they could make a real difference. That passion to do something special, despite the challenges, still drives many of us in emergency medicine today. If you want to do something special, despite the challenge, then head over to FemInEM.org led by Drs. Dara Kass, Esther Choo, Jenny Beck-Esmay and the legend of emergency medicine, Dr. Diane Birnmaumer.  We also recently did an SGEM Xtra: This is My Fight Song - FeminEM 2.0. They are doing some amazing things, advancing gender equity in emergency medicine, improving reproductive healthcare delivery in emergency departments, mentorship and being champions of change. “You know, if I had your job, I’d kill myself.” – John Lovitz This moment of dry sarcasm reflects the burnout and emotional toll our specialty can bring. But it also highlights that, despite the difficulty, emergency medicine remains the best job in the world for many. I couldn’t imagine doing anything else. Emergency medicine still lights me up. “You gotta go where things happen.” – Marla’s Dad This is the heart of advocacy, leadership, and frontline emergency medicine. Whether it’s in the trauma bay or on Capitol Hill, women in emergency medicine are making things happen and often leading the way. You want to feel fulfilled? Go where things happen… or make them happen. “It’s supposed to be hard. If it wasn’t hard, everyone would do it. The hard is what makes it great.” – Jimmy Dugan This is the quintessential emergency medicine quote. The job is hard. The leadership path is hard. Breaking barriers is hard. But that’s what makes it great and worth doing. It’s that difficulty that shapes us, connects us, and gives meaning to what we do. Some final thoughts on the movie A League of Their Own? The movie reminds us that history is full of stories about women rising to the challenge, creating new paths, and demanding space at the table. Progress has been made, but there is still more work to be done. This includes representation in leadership and issues of gender pay gaps. There’s still much to challenge and change, but also much to celebrate. Emergency medicine has its league of extraordinary women, like Dr. Diane Birnbaumer, Dr. Judith Tintinalli, Dr. Dara Kass and many more. They continue to change the game, one shift, one policy, one pitch at a time. What pop culture topic with a strong female message should the SGEM cover next? Send an email to TheSGEM@gmail.com with “Xtra” in the subject line. Who knows, you might be a future guest skeptic on the SGEM. The SGEM will return to start Season#14 with a structured critical appraisal of a recent publication.  We will continue to strive to reduce the knowledge translation window from over ten years to less than one year, leveraging the power of social media. Our ultimate goal is for patients to get the best care, based on the best evidence. Remember to be skeptical of anything you learn, even if you heard it on the Skeptics’ Guide to Emergency Medicine.

Reference: Otterness et al. The Use of TENS for the Treatment of Back Pain in the Emergency Department: A Randomized Controlled Trial. AEM Aug 2025 Date: August 22, 2025 Guest Skeptic: Dr. Lauren Westafer is an Assistant Professor in the Department of Emergency Medicine at the University of Massachusetts Medical School, Baystate. She is the co-founder of FOAMcast and a researcher in pulmonary embolism and implementation science.  Dr. Westafer serves as the research methodology editor for Annals of Emergency Medicine. Case: A 44-year-old man presents to the emergency department (ED) with low back pain after bending to pick up his child. He has pain in his left lower back that is worse when he moves. He has no fever, chills, weakness, or numbness. He has well-controlled hypertension and no history of recent antibiotic use or drug use. The patient has no midline tenderness, is without neurological deficit, and has no red flag features on history and physical exam. He took 500 mg of acetaminophen a few times without significant relief. Background: Back pain is one of the most common reasons patients seek ED care, with an estimated 2.5 million ED visits for back pain each year. After dangerous diagnoses such as spinal epidural abscess, cord compression, and ruptured abdominal aortic aneurysm have been excluded, the next challenge for emergency clinicians is analgesia to improve the patient’s pain and mobility. Unfortunately, there are numerous causes of musculoskeletal low back pain, rendering a single treatment course inconsistently effective for all-comers. Many pharmacological and non-pharmacological therapies have been tried with limited efficacy.  Acetaminophen (Williams et al Lancet 2014) Muscle relaxants (Friedman et al JAMA 2015) NSAIDs (Machado et al Ann Rheum Dis 2017) Steroids (Balakrishnamoorthy et al Emerg Med J 2014) Benzodiazepines (Friedman et al Ann Emerg Med 2017) Cognitive Behavioral Therapy and mindfulness (Cherkin et al JAMA 2016) Chiropractic (Paige et al JAMA 2017) Physical therapy (Paolucci et al J Pain Research 2018) Acupuncture (Colquhoun and Novella Anesthesia and Analgesia 2013) One treatment that can be very effective but comes with very real potential harms is opioids. The American College of Emergency Physicians (ACEP) has addressed the issue of opioid use in patients being discharged home after an acute episode of pain. They give a Level C Recommendation saying: Do not routinely prescribe, or knowingly cause to be co-prescribed, a simultaneous course of opioids and benzodiazepines (as well as other muscle relaxants/sedative-hypnotics) for treatment of an acute episode of pain in patients discharged from the emergency department (Consensus recommendation).  Transcutaneous electrical nerve stimulation (TENS) is a non-pharmacological modality that administers low-intensity electrical stimulation to inhibit nociceptive pain signals. The efficacy of TENS devices in acute low back pain is uncertain. Clinical Question: Is transcutaneous electrical nerve stimulation (TENS) more effective at relieving back pain than sham TENS? Reference: Otterness et al. The Use of TENS for the Treatment of Back Pain in the Emergency Department: A Randomized Controlled Trial. AEM Aug 2025 Population: Adult ED patients (≥18 yr) with thoracic or lumbar back pain of at least moderate severity when research assistants were present (Mon–Fri, 8a–8p). Exclusions: Patients with suspected spinal cord injury or infectious etiology, fractures, hemodynamic instability, allergy to standard analgesics, pacemakers, and those with skin conditions precluding TENS application were excluded. Intervention: Two cutaneous TENS adhesive pads above and below the point of maximal tenderness with TENS unit set at a point just below the pain threshold and gradually increased for up to 30 minutes. Comparison: Sham TENS pads applied but no electrical current. Patients were told they might or might not feel pulses. Outcome: Primary Outcome: Absolute reduction in pain (0–10 NRS) from baseline to 30  Secondary Outcomes: Administration of rescue medications, change in pain severity, patient satisfaction with assigned treatment, and whether patients would recommend the same treatment Trial: Single-center randomized controlled trial Dr. Kara Otterness This is an SGEMHOP, and we are pleased to have the lead author on the episode, Dr. Kara Otterness. She is originally from Illinois and graduated from Drexel University College of Medicine and completed her Emergency Medicine residency training at NYU/Bellevue. She joined the Stony Brook EM faculty in 2015. She is passionate about teaching, medical education and currently serves as one of the assistant program directors at Stony Brook.  Dr. Otterness has been a guest skeptic on SGEM#96.  Authors’ Conclusions: “TENS was more effective than sham TENS at reducing pain severity in adult ED patients with back pain.” Quality Checklist for Randomized Clinical Trials: The study population included or focused on those in the emergency department. Yes The patients were adequately randomized. Yes The randomization process was concealed. Yes The patients were analyzed in the groups to which they were randomized. Yes The study patients were recruited consecutively (i.e. no selection bias). No  The patients in both groups were similar with respect to prognostic factors. Yes  All participants (patients, clinicians, outcome assessors) were unaware of group allocation. No All groups were treated equally except for the intervention. Yes Follow-up was complete (i.e. at least 80% for both groups). Yes All patient-important outcomes were considered. Yes The treatment effect was large enough and precise enough to be clinically significant. Unsure Financial conflicts of interest. None Results: The total cohort consisted of 80 patients. The mean age was 46 years. It was evenly split between female and male patients. The vast majority had lumbar pain (86%), 40% traumatic and 33% recurrent pain. Roughly half of patients had tried self-care with over-the-counter medications, and 31% had used heat.   Key Results: TENS produced a greater reduction in 30-minute pain than sham and reduced the need for rescue meds, with higher satisfaction and similar functional measures. Primary Outcome: The mean difference in change in pain scores was 1.2 (95% CI 0.5-1.9) p=0.002 Secondary Outcomes: Overall, secondary outcomes favoured the intervention. Rescue medications were administered to a higher proportion of patients in the sham TENS group (73% vs 45%), and more patients rated the degree of pain relief as better or much better in the TENS group (55% vs 26%). More patients in the intervention group were satisfied with their treatment (78% vs 50%). Listen to the SGEM podcast to hear Kara respond to our five nerdy points.  Convenience Sample: This trial used a convenience sample of patients enrolled only when research assistants were available (weekday business hours). Restricting recruitment in this way creates a risk of selection bias and limits generalizability because the study population may differ systematically from all ED back-pain patients. For example, patients who present to the ED at night and on weekends may have different injury mechanisms, comorbidities, pain severity or expectations. Compromised Masking: Although the trial was designed to be patient and assessor-mask, most patients correctly guessed their group allocation (95% TENS and 83% sham). When masking is not maintained, especially for subjective outcomes like pain scores, patients’ expectations can influence reported outcomes (placebo/nocebo effects). This can inflate the apparent benefit in the intervention arm, a form of differential measurement bias. True allocation concealment and maintaining blinding integrity are central to avoiding biased estimates of effect in RCTs. However, it is difficult to think about how such an intervention could be delivered without patients guessing correctly. Clinical vs Statistical Significance: The trial’s primary outcome did reach statistical significance (mean pain reduction difference 1.2 points, 95% CI 0.5–1.9) p =0.002. However, the effect size was close to or below many published minimum clinically important difference (MCID) thresholds for acute pain of around 1.5 on a 0–10 scale. Overemphasis on statistical significance without weighing clinical relevance can lead to the adoption of interventions that improve scores in a way that is detectable to researchers but not perceptible or valuable to patients. Small Sample Size: Patient recruitment in the ED is notoriously difficult due to difficulties staffing research staff at all hours of the day and during acute conditions. The authors recruited an adequate number of patients (n=80) for their power analysis; however, this resulted in large confidence intervals and ranges. Small studies are more vulnerable to random error and chance imbalances in prognostic factors, even with randomization. This increases the likelihood that the observed effect could be an overestimate (small-study effect) and reduces confidence in the precision of the result. Single-Centred: Because the trial was conducted in a single ED, the findings may not translate directly to other practice environments. Results from a tertiary academic centre (often with more resources, specialist staff, and research infrastructure) may not reflect community EDs, rural settings, or different health systems. Patient demographics, case mix, staff expertise, and even equipment quality can influence both the feasibility of the intervention and its observed effect. Without replication in multiple, diverse sites,

Reference:  Othman AA, et al. Combined ketamine and midazolam vs. midazolam alone for initial treatment of pediatric generalized convulsive status epilepticus (Ket-Mid study): A randomized controlled trial. Pediatric Neurology. June 2025 Date: May 27, 2025 Dr. James Chamberlain Guest Skeptic: Dr. James Chamberlain is a pediatric emergency medicine attending physician at Children’s National Hospital in Washington, DC where he is the Director of Data Analytics and Informatics for the Division of Emergency Medicine. He is also a Professor of Emergency Medicine and Pediatrics at George Washington School of Medicine and Health Sciences. He has led or co-led two large national trials of status epilepticus and is starting a third, the Ketamine adjuvant for Established Status Epilepticus Treatment Trial (KESETT). Case: A two-year-old boy with a known seizure disorder is brought to the emergency department (ED) by his family for a seizure at home. The episode is described as generalized tonic-clonic activity which self-resolved after about a minute. He was post-ictal afterwards and has not fully returned to baseline. He has not had any recent fevers or illnesses. During your conversation with his parents, he starts seizing again. You administer two doses of a benzodiazepine, but the seizure continues. You give an additional levetiracetam load, which stops the seizure activity, and he is admitted to the hospital for observation. Afterwards, a medical trainee you are working with says to you, “I read that there’s been interest in other medications like ketamine in the treatment of seizures. Do you think there would have been any benefit in giving ketamine earlier?” Background: We often see children presenting with seizures in the ED. Currently, the standard of care recommends the use of benzodiazepines such as midazolam as first-line treatment. Midazolam, but not the other benzodiazepines, can be given intravenously, intramuscularly, intranasally, or as a buccal paste. Sometimes this works and stops the seizure activity. Sometimes it does not. Seizures that are refractory to treatment are dangerous and can lead to neuronal injury, long-term deficits, or even death. We want to stop seizure activity as quickly as we can. The typical management of seizures is to give a benzodiapene. If that does not work, give a second dose. If that still doesn't stop the seizure, then administer another anti-seizure medication like levetiracetam, fosphenytoin, or valproate. There’s been increasing interest in the use of ketamine for seizures. There are several factors that make ketamine potentially a very powerful drug for status epilepticus. Ketamine is an NMDA receptor antagonist and therefore theoretically should break the vicious cycle of status. There have been dozens of animal studies in at least 4 different species demonstrating efficacy as early treatment of status. In some of these studies, ketamine and other NMDA receptor antagonists are neuroprotective. In humans, ketamine is widely used for super refractory status, when all other medications have failed. Estimates are that it is about 70% effective for this indication. We have a long track record of using ketamine safely in the emergency department setting and growing experience in EMS. Ketamine is well tolerated, short-acting, and preserves protective airway reflexes and ventilation. Even very large accidental overdoses have been well tolerated. The one caveat is that we don’t know if all these safety parameters hold in the condition of status epilepticus, but limited case series have not shown safety problems. Currently, it is not part of conventional therapy for pediatric status epilepticus, but there is thought that it may work synergistically with benzodiazepines in stopping seizures. Clinical Question: Is ketamine combined with midazolam more effective than midazolam alone in the treatment of pediatric generalized convulsive status epilepticus? Reference:  Othman AA, et al. Combined ketamine and midazolam vs. midazolam alone for initial treatment of pediatric generalized convulsive status epilepticus (Ket-Mid study): A randomized controlled trial. Pediatric Neurology. June 2025 Population: Children 6 months to 16 years presenting with generalized convulsive status epilepticus without prior treatment with antiseizure medications (ASMs) for the current episode. This was defined as clinically detectable generalized tonic-clonic convulsions that persist or recur without regaining consciousness in between for longer than 5 minutes. Exclusions: Previous treatment with ASM, traumatic brain injury (TBI), conditions associated with increased intracranial pressure, hypertension, glaucoma, hyperthyroidism, pheochromocytoma, end-stage kidney or liver disease, cardiac disease, history of alcohol intake, hypoglycemia, hyperglycemia, inborn errors of metabolism, known allergy or contraindication to study drugs, known or suspected psychiatric disorder, failure to get IV access in first 5 minutes of stabilization, cessation of seizures within the first 5 minutes, and failure to obtain informed consent. Intervention: IV ketamine (2 mg/kg) plus IV midazolam (0.2 mg/kg) Comparison: IV placebo plus IV midazolam Outcome: Primary: Cessation of clinical seizures at 5 minutes post-drug administration Secondary: Need for repeat midazolam during the first 15 minutes of study timeframe, seizure cessation at 15, 35, and 55 minutes, seizure control, adverse events (hypotension, hypertension, arrhythmia, emergence phenomenon, rash), need for intubation, and mortality. Type of Study: Randomized, two-group, parallel, 1:1 superiority, double-masked, placebo-controlled trial Authors’ Conclusions: “Ketamine-midazolam combination may be more effective than midazolam alone for the initial treatment of pediatric GCSE, but this should be confirmed in future research.” Quality Checklist for Randomized Clinical Trials: The study population included or focused on those in the emergency department. Yes The patients were adequately randomized. Yes The randomization process was concealed. Yes  The patients were analyzed in the groups to which they were randomized. Yes  The study patients were recruited consecutively (i.e. no selection bias). Unsure The patients in both groups were similar with respect to prognostic factors. Yes All participants (patients, clinicians, outcome assessors) were unaware of group allocation. Yes All groups were treated equally except for the intervention. Unsure  Follow-up was complete (i.e. at least 80% for both groups). Yes All patient-important outcomes were considered. Yes The treatment effect was large enough and precise enough to be clinically significant. Yes Financial conflicts of interest. No financial conflicts of interest Results: They included 144 children. Half were assigned to the ketamine and midazolam group, and the other half were assigned to the placebo and midazolam group. The most common causes of generalized convulsive status epilepticus include febrile seizures and known epilepsy. Eleven percent had a CNS infection, and four percent had other or unknown etiologies. Key Results: The combination of ketamine and midazolam was superior to midazolam alone in treating children with generalized convulsive status epilepticus. Primary Outcome:  In the combined ketamine and midazolam group, 76.4% of patients had cessation of seizure activity compared to 20.8% of the patients who only received midazolam. Risk Ratio (RR) 3.7 (95% CI: 2.3 to 5.9, p< 0.001) Secondary Outcomes:   The ketamine and midazolam group also had higher percentages of seizure cessation at 15, 35, and 55 minutes. The ketamine and midazolam group had lower percentages of requiring repeat midazolam (23.6% vs 79.3%) or endotracheal intubation (4.2% vs 20.8%). Selection Bias The authors screened 251 patients for eligibility. They excluded around 40% because they didn't meet the inclusion criteria. There was a long list of exclusion criteria. While some of the conditions they excluded could be determined quickly, there are others listed, such as conditions associated with increased intracranial pressure, hyperthyroidism, pheochromocytoma, inborn errors of metabolism, and known or suspected psychiatric disorders that need some time to work up. We’re not sure how they were able to make determinations of all of those potential medical problems before enrollment. This may lead to a selection bias. Primary Outcome Their primary outcome was the cessation of clinical seizure activity, but what about subclinical seizures? One of the challenges in the ED of treating seizures is that we can give medications that stop the clinical seizure activity we can see. Afterwards, when the patient has stopped clinically seizing but is sleepy and has not returned to baseline, we have to try and figure out if they are still not back and baseline because they are post-ictal, sedated from all of the seizure medications, or subclinically seizing. Fortunately, subclinical status is less common in children. It is possible they missed subclinical seizures in this trial, which are important to recognize and treat. From an evidence-based medicine perspective, valid outcome measures are those that are objective, reliably assessed, and aligned with patient-important endpoints. EEG serves as a critical tool to meet these standards in the context of seizure management. Unfortunately, its absence in this trial limits the internal validity and the generalizability to other centers where EEG is routinely used in managing status epilepticus. Future and ongoing studies of status epilepticus in the United States will require placement of a rapid EEG to obviate this ascertainment bias and improves the rigor of the outcome assessment,

Date: July 10, 2025 Guest Skeptics: Professor Timothy Caulfield is a Canadian professor of law at the University of Alberta, the Research Director of its Health Law Institute. His area of expertise is in legal, policy and ethical issues in medical research and its commercialization. This is another SGEM Xtra book review. Tim was our guest skeptic a few years ago, discussing his book called Relax, Dammit! A User’s Guide to the Age of Anxiety. He is back on the SGEM to discuss his latest book called The Certainty Illusion: What You Don't Know and Why It Matters. I asked Tim several questions about his book. Please listen to the podcast to hear his responses.  Questions for Professor Caulfield The book is structured into three main parts. In Part I: The Science Illusion, you examine how scientific language and imagery are co-opted to confer credibility on dubious claims. You discuss how quantum physics has been misappropriated by the wellness and alternative medicine industries. Why do you think "quantum" has become such a powerful marketing tool? The phrase "It’s Science!" is often used to shut down debate. What are the dangers of weaponizing the language of science? You talk about Zombie Science (ideas that refuse to die despite mountains of evidence). I’ve given a lecture for the Gateway Centre of Excellence in Rural Health on zombie ideas about hospital crowding. What is a good example of zombie science in health and wellness? At the end of Part I, you introduce ‘The Humility Fix" as a potential solution. Can you explain why intellectual humility is a necessary antidote to misinformation? In Part II: The Goodness Illusion, you unpack how concepts of health, sustainability, and morality are manipulated to create a false sense of certainty. You explore things like "health halos," in which terms like "clean," "organic," and "natural" are used to mislead consumers. Can you expand on that concept? You list 12 words in total that you call the "Devious Dozen". These are a set of misleading or overhyped health and wellness claims that exploit public perception and create a false sense of certainty. These terms and concepts are often used in marketing, politics, and public discourse to manipulate consumers and reinforce misinformation. Do you have a couple of favourites? You also talk about how virtue signalling and ideological narratives shape public opinion, often overriding evidence-based reasoning. The idea that our desire to do what’s "right" can be exploited through misleading claims about health, wellness, and even sustainability. What’s an example of this in the medical field, and how can healthcare professionals push back against it? You also discuss the White Hat Bias in this section of the book. It is a phenomenon where research findings are distorted in the service of what is perceived as a noble or righteous cause. This bias leads to the overrepresentation of certain findings, particularly in fields like public health, nutrition, and medicine, where there is strong societal motivation to support outcomes. Who coined the term White Hat Bias? Can you give an example of the White Hat Bias from the COVID-19 pandemic? In Part III of the book, you discuss The Opinion Illusion. This delves into how the digital age has fueled an economy of opinion, where ratings, reviews, and social media influence create misleading perceptions of truth and expertise. How has the “opinion economy” shaped modern decision-making? How has this shift impacted our ability to discern truth from misinformation? You highlight the influence of online reviews and rankings. Why do people trust anonymous reviews more than expert opinions or personal recommendations? What role do algorithms play in distorting our perception of consensus and credibility?  The book isn’t all doom and gloom. You do offer some solutions for navigating this chaotic information environment.  What would it look like if you could design an ideal system for verifying the credibility of online opinions? How can individuals cultivate a healthier skepticism toward online rankings without becoming entirely cynical? What role do educational institutions and policymakers play in addressing the certainty illusion in digital spaces? You mention that authenticity itself has been commodified. Do you think there is a way to reclaim genuine trust in reviews and expert opinions? What’s the most surprising or unexpected thing you discovered while researching The Certainty Illusion? That’s it for this SGEM Xtra. Remember, the SGEM is about cutting the knowledge translation (KT) window down from over ten years to less than a year, but ultimately, it’s about patients getting the best care, based on the best evidence. REMEMBER TO BE SKEPTICAL OF ANYTHING YOU LEARN, EVEN IF YOU HEARD IT ON THE SKEPTICS’ GUIDE TO EMERGENCY MEDICINE.

Reference: Kemal et al. Emergency department utilization by youth before and after firearm injury. AEM July 2025 Date: July 28, 2025 Guest Skeptic: Dr. Kirsty Challen is a Consultant in Emergency Medicine in the UK and an evidence-based medicine advocate. She's a seasoned knowledge translator with her wonderful PaperinaPic infographics.   Case: Your non-US emergency department (ED) has recently been shaken by the attendance of a teenager with a gunshot injury. Subsequent investigation has found he attended a different hospital in the region six weeks ago with a stab wound. The team wonders if that attendance was an opportunity to intervene. Background: Firearm injuries are now the leading cause of death in youth in the United States, surpassing motor vehicle collisions.[1] While the immediate clinical management of gunshot wounds is well covered in emergency medicine training, there is less clarity around what happens before and after that ED visit. Could we identify these high-risk youth earlier? Do patterns of ED use provide clues for intervention? The ED often serves as the primary healthcare contact point for youth exposed to community violence. Some youth injured by firearms may have prior ED visits for mental health crises or minor injuries, presenting opportunities for preventative strategies. But are we missing these cues? Additionally, once youth survive a firearm injury, they face elevated risk for repeat injury, psychological trauma, and even death. Understanding post-injury healthcare utilization may reveal missed chances for intervention, particularly in general EDs that may lack pediatric-specific resources. Clinical Question: Do youth with firearm injuries have increased emergency department utilization before and after their injury compared to their peers? Reference: Kemal et al. Emergency department utilization by youth before and after firearm injury. AEM July 2025 Population: Youth aged 10 to 19 years who had an index ED visit for a firearm injury in 2019 across eight US states, identified from the Healthcare Cost and Utilization Project database. Exclusion: Youth who lacked the data to assess 90 days before or after the index injury, and those without longitudinal ED visit linkage, injuries from non-power firearms, and recurrent visits with firearm injury. Exposure: Having sustained a firearm injury as indexed by an ED visit. Comparison: ED utilization by the same patients in the 90 days before and after the firearm injury. Outcomes: Primary Outcome: Number and types of ED visits 90 days before and after the index firearm injury. Secondary Outcomes: Types of ED visits and recurrence of trauma. Type of Study: Retrospective cohort study using linked administrative claims data. Dr. Samaa Kemal This is an SGEMHOP, and we are pleased to have the lead author on the episode. Dr. Samaa Kemal is an early-career pediatric emergency medicine clinician-investigator at Ann & Robert H. Lurie Children's Hospital of Chicago. Her work is primarily focused on the intersection of violence and health equity in children. Her research priorities are focused on developing and implementing novel and effective solutions to prevent violent injuries and subsequent adverse outcomes in children.  Authors’ Conclusions: “Youth have high rates of ED utilization before and after firearm injury. Half of firearm-injured youth receive their emergency care exclusively in general EDs. Implementing firearm injury prevention and intervention efforts in all ED settings is critical.” Quality Checklist for Observational Study: Did the study address a clearly focused issue? Yes Did the authors use an appropriate method to answer their question? Yes Was the cohort recruited in an acceptable way? Yes Was the exposure accurately measured to minimize bias? Yes Was the outcome accurately measured to minimize bias? Yes Have the authors identified all important confounding factors? No Was the follow-up of subjects complete enough? Yes How precise are the results? Fairly precise Do you believe the results? Yes Can the results be applied to the local population? No Do the results of this study fit with other available evidence? Yes Funding of the Study? Eunice Kennedy Shriver National Institute of Child Health and Human Development Results: The median age was approximately 17 years; predominantly male and from racially minoritized groups. Key Result: Youth frequently used EDs before and after injury, suggesting opportunities for early identification and intervention. Primary Outcome: 12.8% of youth had at least one ED visit in the 90 days before the firearm injury, and 22.1% had at least one in the 90 days after. Secondary Outcomes: Of those with post-injury ED visits, 26% had recurrent trauma; mental health and assault-related visits were common. Listen to the SGEM podcast to hear Samaa answer our five nerdy questions.  Confounding by Indication and Unmeasured Covariates: One of the primary threats to internal validity in observational studies is confounding. This is especially true when data sources like administrative datasets lack key clinical variables. In this study, firearm-injured youth were not matched to potential confounders such as socioeconomic status, prior trauma history, or mental health diagnoses beyond what was coded. How do you think these unmeasured confounders bias the estimates of associations, because differences in post-injury ED use may reflect underlying vulnerabilities rather than the effect of firearm injury? Linkage, Follow-up and Dependence on Datasets: You chose these states because you considered that the linkage between ED and inpatient databases was most accurate. Could you talk us through that? How do you assess the accuracy of linkage? Misclassification of Exposure or Outcome Using Administrative Codes: The reliance on ICD-10 and Clinical Classification Software codes in the Healthcare Cost and Utilization Project (HCUP) databases raises the risk of misclassification bias. Diagnosis codes may be inconsistently applied, and key distinctions such as intentional vs. unintentional firearm injury or severity of psychological outcomes might be missed. Such misclassification is particularly problematic if it differs systematically between groups, which could attenuate or exaggerate true differences in ED utilization. What steps did you take to mitigate against misclassification bias? Lack of Information on Non-ED Care and Social Determinants of Health: The study's reliance solely on ED and inpatient data from the HCUP SID and SEDD datasets omits health care utilization in outpatient, urgent care, or community mental health settings. This may underestimate or misrepresent total healthcare use, particularly for youth who might shift to non-ED resources post-trauma. How do you think this gap could bias interpretations about the burden on emergency services, thus threatening external validity when generalizing to broader healthcare utilization patterns? Temporal Ambiguity and Reverse Causation Risks: Although the study uses a pre-post design anchored on the injury date, temporal ambiguity remains a concern. Reverse causation refers to a scenario where the outcome is not solely a consequence of the exposure, but rather that both the exposure and outcome share a common underlying cause, or that the outcome may have even predatedor influenced the exposure. For example, higher ED utilization post-injury could be attributed not only to the firearm event itself but also to progressive deterioration from unmeasured pre-existing factors. What do you think about the potential for reverse causation? Comment on the Authors’ Conclusion Compared to the SGEM Conclusion: The authors’ conclusions are supported by the data but should be interpreted with caution. While they call for adapting interventions to all general EDs, this study cannot determine whether such interventions would be effective. SGEM Bottom Line: Firearm-injured youth frequently present to the ED both before and after injury, representing potential missed opportunities for prevention and follow-up care. Case Resolution: The second ED visit wasn't entirely unpredictable. The best predictor of future behaviour is often past behaviour. Recognizing this pattern, your hospital begins piloting a violence intervention program targeting youth with prior ED visits for assault or behavioural concerns. The plan on collect data and see if the intervention has a positive impact. Dr. Kirsty Challen Clinical Application: ED providers could use visit history to flag high-risk youth and advocate for violence intervention referrals, social work consults, or follow-up care plans. However, there is a lack of evidence that such interventions would be effective. Further studies are needed to test various interventions, especially in non-pediatric EDs. What Do I Tell the Patient? You have had a couple of visits to the ED recently. We are worried about you. Are you interested in talking to someone about the violence in your life? Keener Kontest: The last episode’s winner was David Pecora. He knew that STI we were looking for was Syphilis. The word syphilis comes from the mythic Greek shepherd, Syphilus, who was cursed by the god Apollo with a dread disease Listen to the SGEM podcast for this week’s question. If you know, then send an email to thesgem@gmail.com with “keener” in the subject line. The first correct answer will receive a shoutout on the next episode. Now it is your turn, SGEMers. What do you think of this episode on youth firearm injury and ED utilization? What questions do you have for Samaa and their team? Post your comments on social media using #SGEMHOP. The best social media feedback will be published in AEM. Remember to be skeptical of anything you learn,

Reference: Bourke EM, et al. PEAChY-O: Pharmacological Emergency Management of Agitation in Children and Young People: A Randomized Controlled Trial of Oral Medication. Annals of Emergency Medicine. Feb 2025 Date: April 29, 2025 Guest Skeptic: Dr. Brad Sobolewski, is a pediatric emergency medicine physician at Cincinnati Children’s Hospital and Professor of Pediatrics at the University of Cincinnati College of Dr. Brad Sobolewski Medicine. He is the creator of the PEMBlog and host of PEM Currents: The Pediatric Emergency Medicine Podcast. Brad is passionate about using digital media to translate complex clinical concepts into engaging, accessible educational content. His work centers on advancing knowledge sharing through innovative, tech-forward approaches to medical education. Case: A 14-year-old girl with no known medical or psychiatric history presents to the emergency department (ED) with her family for aggression. Her parents tell you that they have been getting into arguments a lot recently. Today, she became so angry that she started punching and kicking the walls at home. You interview the girl and perform your physical examination, and determine that there are likely no medical diagnoses contributing to her aggression, nor that she has sustained any injuries requiring immediate management. After you leave the room and her parents enter, you hear them get into another argument, and she gets more agitated. The staff try a combination of de-escalation techniques, but she continues to be aggressive and starts threatening the staff. A nurse working with you asks, “I don’t think our de-escalation techniques are working. Do you want to give her something to help calm her down? We have olanzapine or diazepam here. Which one do you want to give?”  Background: Pediatric agitation can be defined as a clinical state characterized by heightened motor activity, emotional arousal, and often aggressive or disruptive behavior outside of expected developmental norms. It can be triggered by many things like underlying psychiatric disorders, medical conditions (like delirium, hypoxia, or metabolic disturbances), substance intoxication or withdrawal, and situational stressors, such as hospitalization or separation from caregivers​. In the ED setting, pediatric agitation presents unique challenges. Not only can it compromise the safety of the child, caregivers, and medical staff, but it can also delay care and exacerbate underlying conditions​. When a child presents with extreme agitation or aggression, the first step is to take a broad, thoughtful approach. We can’t just assume it’s a psychiatric issue. Medical causes like hypoglycemia, intoxication, or even something like new-onset diabetic ketoacidosis can present this way. Missing these diagnoses could be dangerous. Once we’ve ruled out organic causes, the focus shifts to early recognition and de-escalation. We try to identify the signs that a child is becoming more agitated before they escalate further. The goal is to intervene early and often with non-pharmacologic strategies. This can mean adjusting the environment: dimming the lights, reducing noise, giving the child space, or removing extra staff from the room. Sometimes something as simple as offering a snack, a drink, or a comfort item can make a big difference. Re-direction, distraction, and using calm, supportive language can also go a long way. Of course, there are times when those strategies aren’t enough, and we may need to use physical restraints or medications. But that should never be our starting point. The overarching goal is to approach these situations with empathy and respect. Support the child and their family while protecting everyone’s safety, including our own. There’s no perfect medication for agitation so it really depends on the situation. If the child is cooperative, start with an oral option. It gives the child a bit of control and helps avoid the trauma of restraint or an IM injection. When oral meds aren’t possible and the child poses a risk to themselves or others, IM options may be necessary. In those cases, it’s important to know what medications (dosing, onset, and potential side effects) are available and what local protocols recommend. The choice also depends on why the child is agitated. Antipsychotics, benzodiazepines, antihistamines, or even ketamine all have a role, but each comes with considerations based on the child’s history and the clinical scenario. Whatever we use, the goal is to reduce distress safely and respectfully, while keeping everyone protected. Brad I have actually done a whole podcast series in collaboration with the EMSC innovation and Improvement Center and emDocs on agitation. Clinical Question: Is oral olanzapine or oral diazepam more effective in achieving successful sedation in pediatric patients with acute severe behavioral disturbances? Reference: Bourke EM, et al. PEAChY-O: Pharmacological Emergency Management of Agitation in Children and Young People: A Randomized Controlled Trial of Oral Medication. Annals of Emergency Medicine. Feb 2025 Population: Children ages 9 to 17 years presenting to the ED with acute severe behavioral disturbances (Sedation Assessment Tool score of +1 to +3) that persisted despite nonpharmacological management that the clinician deemed to require oral medication Excluded: Known allergy or contraindication to the study medication, pregnant patients, history of known long QT syndrome, reversible organic cause contributing to agitation, parent/guardian request/refuse study drugs, treating clinicians decided alternative route, drug, or therapy was more appropriate Intervention: Oral dose of olanzapine​. Comparison: Oral diazepam. Outcome: Primary: Successful sedation (Sedation Assessment Tool (SAT) score ≤ 0 without need for additional sedation one-hour post-randomization)​. Secondary: Parent/guardian and medical staff satisfaction, medication-related adverse events, length of stay, disposition, and whether the participant ingested medication. Trial: Open-label, multicenter, randomized controlled trial. Authors’ Conclusions: “There was no evidence that oral olanzapine resulted in a greater proportion of participants with acute severe behavioral disturbance achieving successful sedation at one hour post randomization than oral diazepam. Neither medication resulted in any serious adverse events; however, approximately 40% of participants in each group did not achieve successful sedation.” Quality Checklist for Randomized Clinical Trials: The study population included or focused on those in the emergency department. Yes The patients were adequately randomized. Yes The randomization process was concealed. Yes The patients were analyzed in the groups to which they were randomized. Yes The study patients were recruited consecutively (i.e. no selection bias). Unsure The patients in both groups were similar with respect to prognostic factors. Yes All participants (patients, clinicians, outcome assessors) were unaware of group allocation. No  All groups were treated equally except for the intervention. Unsure Follow-up was complete (i.e. at least 80% for both groups). Yes  All patient-important outcomes were considered. Yes The treatment effect was large enough and precise enough to be clinically significant. No Financial conflicts of interest. No financial conflicts of interest Results: They enrolled 348 patients across nine sites. 176 were in the olanzapine group and 172 were in the diazepam group. Median age was around 15 years, with slightly more female patients. Key Results: Oral olanzapine and diazepam had similar efficacy in achieving successful sedation in children with acute severe behavioral disturbance. However, 40% of participants in each group were not successfully sedated. Primary Outcome: In the olanzapine group, 61% of participants were successfully sedated compared to 57% from the diazepam group. (aRD 3.6%, 95% CI -6.7 to 14, p=0.49). 10% of patients in both groups received additional sedation medication prior to measurement of the primary outcome. Secondary Outcomes: There was not much difference between the two groups in many of these outcomes. 2% in each group had a study-related adverse event (aRD 0.5%, 95% CI -4.2 to 5.3) by first hour post randomization. There were a few more adverse events up until time of discharge or 48 hours after discharge, 3% in the olanzapine group compared to 4% in the diazepam group. This difference was not clinically significant (aRD -3.6%, 95% CI -7.9 to 0.6). Further episodes of behavioral disturbance (23% olanzapine vs 26% diazepam) and requirement for mechanical restraints were also similar between the two groups. Selection Bias During the study, 491 patients were eligible but not enrolled. We are not certain why these patients were missed. Additionally, one of the inclusion criteria was that the patient had a behavioral disturbance that persisted despite nonpharmacological management, and the clinician determined required oral medications. We must acknowledge that while this is pragmatic, there is a great degree of subjectivity in that decision. There is a related trial including patients who received IM medications. Caution with Disparities We are glad that the authors included ethnicity in the patient demographics. We must acknowledge that despite our best efforts, we are not perfect, and disparities are present in the care we provide [1]. In the United States, studies demonstrate children of color are less likely to get pain medications for fractures or appendicitis and more likely to get mistriaged in the emergency department. These disparities exist in mental health and management of behavioral crises as well.

Date: July 9, 2025 Guest Skeptics: Dr. Cindy Bitter is an Associate Professor in the Division of Emergency Medicine at Saint Louis University. She has a Master’s in Bioethics, and she is passionate about EM capacity building and physician resilience, especially improving wellness through time in nature.    Dr. Amy Bi is a graduate from the SSM Health Saint Louis University Emergency Medicine residency and the University of Missouri School of Medicine. She is interested in continuing medical education, orange theory, and travelling. This is an SGEM Xtra episode, which takes us back to the late '90s to explore the intersection of pop culture and professional practice through the lens of Buffy the Vampire Slayer. It's similar to the episodes we did about Star Trek, Top Gun, Dark Knight, Ted Lasso, and The Pitt. Cindy reached out to me about a presentation she made at the HumanisEM conference. It's an interdisciplinary conference that explores the intersections of the Health Humanities and Emergency Medicine, started in 2023. The presentation at the conference was inspired by a conversation with female residents about why Buffy remains a must-watch show for young professionals, especially in medicine. In the lecture, we explore lessons from the show that resonate with emergency physicians and healthcare professionals. Click on the LINK for a copy of the slides. There may be some people like me who are not familiar with the show. Buffy the Vampire Slayer premiered in 1997 and ran for seven seasons. Its central premise was that the seemingly dumb blonde chick who is the first to get killed in horror movies is trained to fight back. Ultimately, the monsters were symbols of the challenges we face on the way to growing up and creating a meaningful life. The show hid a healthy dose of existential philosophy under the quips, music, and 90s fashion, and continues to gain fans more than 20 years after it ended. Career Advice from Buffy the Vampire Slayer Honour Your Calling Quote: “You talk about slaying like it’s a job, it’s not. It’s who you are”. What’s My Line? Part 2; S2, ep 10. Writer: Marti Noxon Our path in medicine is somewhat different than the “one girl in all the world” who is destined to fight the forces of darkness, but there are analogies. Buffy sometimes struggles with her calling but ultimately accepts her path (Prophecy Girl). And she shows that this is not a single event, but something she chooses every day (What’s My Line, Anne, Amends). We come to medicine with our own set of strengths and skills, choose our path, and actively reaffirm it as we complete years of education and residency training. There are certainly challenges in our healthcare system, but there is also connection and sometimes even joy. Meeting Challenges Quote: “Bottom line is, even if you see 'em coming, you're not ready for the big moments. No one asks for their life to change, not really. But it does. So, what are we, helpless? Puppets? No. The big moments are gonna come. You can't help that. It's what you do afterwards that counts. That's when you find out who you are.” Becoming, part 1; S2, ep 22. Writer: Joss Whedon Quote: “From now on, we won’t just face our worst fears, we will seek them out. There’s only one thing in this world more powerful than evil, and that’s us.” Bring on the Night; S7, ep 10. Writer: Marti Noxon with Douglas Petrie Medical school, residency, and even attending life are filled with learning from students, residents, coworkers, nurses, colleagues, and administrators. We must incorporate new evidence into our practice, learn from mistakes, and improve for future encounters. New situations come at us all the time; it’s how we strategize and confront them that counts. That might mean reading up on disease presentations we do not see often or practicing high-acuity, low-occurrence procedures. Knowing we are prepared for the challenges we see can give us confidence. Work-Life Balance and Leaning into your Humanity Quote: “It’s the 90s, the 1990s in point of fact. I can do both. Clark Kent has a job, I just want to go on a date… If the apocalypse comes, beep me.” Never Kill a Boy on the First Date; S1, ep 5. Writer: Rob Des Hotel & Dean Batali Quote: “You know how you’re always trying to save, oh, every single person in the world? Did it ever occur to you, you are one of them?” You’re Welcome. Angel S5, ep 12. Writer: Joss Whedon, David Greenwalt, David Fury One theme in the early seasons of BtVS is the tension between Buffy’s duties as a Slayer and her desire to have a normal life. This sometimes goes awry, as her efforts to continue her normal high school activities find her hexed (Witch), rendered helpless by a cursed Halloween costume (Halloween), and almost eaten by a lizard demon (Reptile Boy). But eventually, she finds a path that provides her a stable-ish home life and meaningful friendships while being a Slayer. In season five, Buffy cuts herself off from her emotions, worrying that the burdens of being the slayer are turning her to stone. To be successful and avoid burnout, we must process the sorrows we encounter and lean into the joy. We often make tough choices without full information, doing the best we can with less-than-optimal situations. Sometimes we can offer reassurance that a patient’s symptoms are not dangerous, sometimes we must tell patients or families about an impending death, sometimes the best we can offer is a comforting presence and minimizing suffering. We must offer ourselves the same grace we give so freely to others. Challenging Dogma Quote: “I appreciate your thoughts on the matter, in fact I encourage you to always challenge me when you feel it’s appropriate. You should never be cowed by authority. Except, of course, in this instance, when I am clearly right and you are clearly wrong.” I Only Have Eyes for You; S2, ep 19. Writer: Marti Noxon Much of what we do in EM is not well-grounded in the medical evidence, but it is important to seek out new evidence and stay current in the literature. And acknowledge things that are tradition or “dogma” rather than evidence-based. Some of us will even choose to contribute to expanding that evidence base! But it is crucial to be a critical reader of the literature even if research “isn’t your thing”. This is especially important to me as an attending - I ask our senior residents to teach me something every shift - sometimes from an article they read, a podcast I haven’t listened to, or a new technique with ultrasound. Being a Girl and A Badass  Quote: “Yes, date, and shop, and hang out, and go to school, and save the world from unspeakable demons. You know, I want to do girly stuff”. Faith, Hope and Trick; S3, ep 3. Writer: David Greenwalt Quote: “Did we not put the “grr” in girl? Living Conditions,S4, ep2. Writer: Marti Noxon Replace “demons” with “diseases,” and you have a pretty good mission statement for Women in Medicine. Buffy starts the show as a stereotypical high school girl, more interested in clothes and popularity than academics or saving the world. As she grows into her role, she incorporates her fashion sense into the job, patrolling in her favourite orange tank top and her “stylish yet affordable” boots. She is physically strong, but never feels the need to suppress her feminine side to fulfill her duties as Slayer. Likewise, we can be our authentic selves and show our personality while fulfilling our professional roles - wear those colourful scrubs or your favourite rhinestone barrette on duty. Final thoughts about what you learned from the TV series Buffy the Vampire Slayer Seeking Mentorship and Asking for Help  Quote: “Sometimes the most adult thing you can do is ask for help when you need it.” Grave, S6, ep 22. Writer: David Fury The mentor/ surrogate father relationship between Buffy and her Watcher, Mr. Giles is one of the best-developed relationships in the show. Mr. Giles loses his position in the Watchers Council over his affection for his charge. Several new Watchers are sent, but Buffy leaves the Council when it proves unwilling to support her objectives. After some months without a formal mentor, Buffy again asks Giles to be her Watcher. Even after she completes her formal training, she recognizes her need for mentorship and seeks out Mr. Giles’ help. In the final season of the show, Buffy becomes a mentor, responsible for all the potential Slayers who have not yet been called. She tries to train them, but early on, they lack the strength and the focus needed to take on the role. In the series finale, she finds a way to share her power with the Potentials, building an army to defeat evil.  Finding Your Team - The Power of Friendship It cannot be summarized into a single quote from the show, as it happens so many times that a one-liner doesn’t capture the theme, but… Buffy’s friends are known as the Scoobies, and each of them plays an important role in her mission. This is called out by one of the villains as a reason that Buffy has lasted longer in the role of Slayer than most. As Buffy draws strength from her friends, our relationships with our families, friends and coworkers can help us through rough times. Women in EM must lift each other, sharing resources, collaborating on scholarly activity, and even socializing, which can remind us that we don’t have to do it alone. Criticisms/Controversies Though celebrated for its feminist themes, the show has also been critiqued for embodying a narrow brand of feminism. Issues include: Costume choices catering to the male gaze Outdated jokes and stigmas (e.g., gay panic, slut-shaming, fat-phobia) Toxic behaviours that go unaddressed

Reference: Arnold CG, et al. Performance of individual criteria of the Pediatric Emergency Care Applied Research Network (PECARN) intraabdominal injury prediction rule. Acad Emerg Med. Jan 2025 Date: May 7, 2025 Dr. Sandi Angus Guest Skeptic : Dr. Sandi Angus is a Paediatric and Adult Emergency Medicine Registrar in the Shrewsbury and Telford Hospital NHS Trust. She is passionate about paediatric EM, wellbeing and medical education. Case: A ten-year-old boy presents to your emergency department (ED) after being involved in a motor vehicle collision at high speed. Emergency Medical Service (EMS) tells you that he was properly restrained. His parents were also in the vehicle and are currently being brought to the ED as well. He appeared a bit dazed initially, but he has had a Glasgow Coma Scale (GCS) score of 15 throughout transport. Your primary survey is unremarkable. He complains of some abdominal pain, although you note a soft abdomen on exam and no seatbelt sign. As you complete your secondary survey, he vomits once, which is non-bloody. A medical trainee working with says to you, “He says his stomach hurts and threw up. Do you think we need to CT scan his abdomen?” Background: Intra-abdominal injury (IAI) in children is a significant concern for emergency physicians. This is particularly true in cases of blunt trauma. Although relatively uncommon compared to adults, IAIs in children can be life-threatening. We have to identify them early and manage them appropriately. The organs most frequently injured include the spleen, liver, and kidneys, but any abdominal organ can be affected​. Diagnosing IAIs in pediatric patients poses a unique challenge. Children often present with subtle clinical findings, and the physical examination can be unreliable due to factors such as altered mental status, distracting injuries, or the child’s inability to articulate their symptoms​. Imaging modalities like computed tomography (CT) are the gold standard for diagnosis, but CT use must be balanced against the risks of ionizing radiation. Traditionally, clinicians relied heavily on their clinical gestalt, but this approach can miss injuries or lead to unnecessary imaging. The risks of CT imaging are not inconsequential. Children are more radiosensitive than adults, and for each  abdominal or pelvic scan, the lifetime risks of cancer are 1 per 500 scans, irrespective of the age at exposure. However, this is actually very small compared with the background risk of developing cancer in a lifetime, which is 1 in 3, so if your scan is clinically justified, the benefit is likely to outweigh the potential harm [1]. To improve diagnostic accuracy and minimize unnecessary CT scans, clinical decision rules (CDRs) or “tools” have been developed. One such tool, the Pediatric Emergency Care Applied Research Network (PECARN) clinical prediction rule for intra-abdominal injuries, identifies children at very low risk of clinically important IAIs, aiming to safely reduce CT utilization​ [2-3]. This rule was composed of seven variables, all of which could be collected on history and physical exam. There was no need for labs or imaging in this decision rule. These seven variables were: Evidence of abdominal wall trauma or seat belt sign GCS <14 and blunt abdominal trauma Abdominal tenderness Thoracic wall trauma Complaint of abdominal pain Decreased breath sounds Vomiting If all seven variables were negative, the child was at very low risk of having intra-abdominal injury requiring intervention and the decision rule recommended against a CT scan. Despite the benefits of existing decision rules, the question remains how best to apply these tools when only one or two PECARN criteria are positive—a clinical gray zone not well characterized in earlier validation studies. Understanding the individual performance of PECARN rule components in predicting IAI is crucial for refining decision-making in pediatric trauma care. Clinical Question: What is the risk for intraabdominal injuries requiring acute intervention (IAIAI) in children with one or two positive PECARN intraabdominal injury rule variables? Reference: Arnold CG, et al. Performance of individual criteria of the Pediatric Emergency Care Applied Research Network (PECARN) intraabdominal injury prediction rule. Acad Emerg Med. Jan 2025 Population: Children <18 years with blunt torso trauma Excluded: Injury occurring >24 hours before ED presentation, penetrating trauma, pre-existing neurological disorder preventing reliable abdominal exam, pregnancy, transfer from another hospital with prior abdominal imaging. All patients who were negative for the original PECARN prediction rule or had more than two variables present. Intervention: Application of the PECARN intraabdominal injury prediction rule with one or two positive variables Comparison: None Outcome: Primary Outcome: Intraabdominal injury undergoing acute intervention (death caused by IAI, therapeutic laparotomy, angiographic embolization, blood transfusion, or ≥2 nights of IV fluids). Secondary Outcomes: Any intraabdominal injury (injuries to the liver, spleen, urinary tract, gastrointestinal tract, pancreas, gallbladder, adrenals, vasculature, or fascial defects).  Trial: Planned secondary analysis of a prospective multicenter observational study Authors’ Conclusions: “Few children with blunt torso trauma and one or two PECARN predictor variables present have IAIAI. Those with GCS score <14, however, are at highest risk for IAI.” Quality Checklist for Clinical Decision Rules: Did the study population include or focus on those in the emergency department? Yes Where was the study conducted (external validity)? Six emergency departments in the United States Were the patients included in the study representative of those with the problem? Yes Were all important predictor variables and outcomes explicitly specified? Yes Is this a prospective, multicenter study including a broad spectrum of patients and clinicians (Level II study)? Yes Did clinicians interpret individual predictor variables and score the clinical decision rule reliably and accurately? Unsure (not detailed clearly in the abstract) Is this an impact analysis of a previously validated clinical decision rule (Level I study)? No For a Level I study, was the impact on clinician behavior and patient-centric outcomes reported? N/A Was the follow-up sufficiently long and complete? Yes Was the effect large enough and precise enough to be clinically significant? Yes Who funded the trial? Eunice Kennedy Shriver National Institute of Child Health and Human Development Did the authors declare any conflicts of interest? No conflicts declared Results: The original study included 7,542 children with blunt torso trauma across six emergency departments. Of those children, 2,986 (39.6%, 95% CI 38.5 to 40.7) had one or two PECARN positive variables. The median age was 9.8 years and slightly over half (56%) were male. CT scans were obtained in 1236 (41%) of the patients. Key Results: Few children with one or two positive PECARN rule variables had IAI, with the highest risk in those with GCS <14. The presence of isolated abdominal pain, vomiting, or tenderness was not associated with IAI. Primary Outcome: Of the 1,639 patients who had one variable positive, 21 (1.3%, 95% CI 0.8-2) had intra-abdominal injuries undergoing acute intervention. Of the 1347 who had two variables positive, 27 (2%, 95% CI 1.3-2.9) had intra-abdominal injuries undergoing acute intervention. Secondary Outcome: Of those 2986 patients enrolled, 227 (7.6%, 95% CI 6.7-8.6) had intra-abdominal injuries. They also broke it down by each individual variable and how many patients were diagnosed with intra-abdominal injury and intra-abdominal injury undergoing acute intervention. GCS≤14 was the most important individual predictor variable for intra-abdominal injury undergoing acute intervention. Inclusion Criteria: It’s important to review the inclusion criteria from the original study because we do not think this clinical decision rule should be applied indiscriminately to every child with abdominal trauma. A large proportion of the children included in the original study had some pretty severe mechanisms of injury (32% from motor vehicle collisions, 19% were struck by a vehicle, and 13% due to fall from height. Be careful in applying this clinical decision tool to less severe mechanisms. They excluded patients who had injury that occurred over 24 hours ago. Many of us may have encountered a patient in the emergency department who complains of belly pain from a blunt abdominal injury a day ago and were perhaps seen at an urgent care facility or tried to wait it out. Although they were not part of the patient population in this study, would it be inappropriate to use this clinical decision tool on those patients? Partial Verification Bias: In this secondary analysis, only around 40% of patients included had CT scans. What about those who did not? In the original derivation study, there was one patient with a splenic laceration who returned after being discharged from the ED without imaging who underwent splenic artery embolization. It is possible that some of these patients who did not undergo CT scan still had intra-abdominal injuries that were missed. This does highlight the primary outcome that they defined as IAI undergoing acute intervention. It is arguably more patient oriented, they missed some IAI but maybe it was not clinically significant. I’ve admitted low grade splenic or liver laceration to the hospital who were observed without any intervention except a repeat hemoglobin before being sent home. Spectrum Bias: