Authors: Steven M. Green, Daniel S. Tsze, Mark G. Roback
Journal: Annals of Emergency Medicine, 2025
DOI: 10.1016/j.annemergmed.2025.05.003
Study Type: Observational registry analysis
Data Source: Pediatric Sedation Research Consortium (PSRC)
Time Frame: July 1, 2004 – July 1, 2024
🔍 Background and Rationale
Ketamine remains one of the most frequently used agents for procedural sedation in pediatric emergency departments. Despite its widespread use and strong safety record, questions have persisted regarding its risks—particularly in children with upper respiratory infections, obstructive sleep apnea, or other predisposing factors.
Previous studies, including a 2009 meta-analysis, were limited in size and scope. The PSRC offered a unique opportunity to evaluate ketamine use across thousands of cases in a real-world, multicenter emergency department setting.
🎯 Study Objectives
- To quantify the frequency of critical and high-risk adverse events during ketamine-only procedural sedation in children.
- To identify clinical predictors associated with these adverse outcomes.
🧪 Methods
- The study analyzed 12,780 pediatric ketamine sedation encounters from 84 institutions over a 20-year period.
- Only cases where ketamine was used as the sole sedative in emergency departments were included.
- Adverse events were categorized as:
- Critical: Events involving potential for death or long-term harm.
- High-risk: Events requiring active intervention but without long-term harm (e.g., laryngospasm, apnea requiring ventilation).
📊 Results
✅ Critical Events
- Incidence: 2 cases (0.016%; 95% CI 0.0019–0.057)
- Details:
- One case of suspected pulmonary aspiration (no desaturation, no intervention).
- One case of anaphylaxis requiring unplanned hospitalization.
- Outcome: No deaths or permanent harm.
⚠️ High-Risk Events
- Incidence: 67 events (0.52%; 95% CI 0.41–0.66)
- Breakdown:
- 41 cases required positive pressure ventilation
- 36 cases involved apnea
- 7 cases involved laryngospasm
🔍 Predictive Factors
- Increased Risk:
- Age ≥10 years
- Opioid co-administration
- Not Predictive:
- Upper respiratory infection
- Obstructive sleep apnea
- Higher American Society of Anesthesiologists (ASA) physical status
📌 Study Limitations
- Self-Reported Data: The registry relies on voluntary reporting, which may introduce reporting bias or inconsistencies in event classification.
- Institutional Variability: Differences in sedation technique, monitoring standards, and provider experience across centers may affect the generalizability of findings.
- Lack of Narrative Detail: Limited qualitative data on how adverse events were recognized and managed.
- Observational Design: No causality can be inferred; only associations are described.
💡 Clinical Implications
- Reassurance with Evidence: The findings reinforce the exceptional safety profile of ketamine in pediatric procedural sedation—especially when used alone.
- Opioid Caution: Combining opioids with ketamine should be done judiciously, particularly in older children.
- Rethinking Contraindications: Traditional avoidance of ketamine in children with upper respiratory infections or obstructive sleep apnea may warrant reconsideration, as these factors were not associated with increased adverse events.
- Airway Readiness Still Paramount: While serious complications are rare, sedation should always be performed with full monitoring, skilled personnel, and immediate airway intervention capability.
🧠 Conclusion
This landmark study provides the most robust evidence to date on the safety of ketamine as a sole sedative agent in pediatric emergency departments. With an extremely low incidence of critical events and a manageable profile of high-risk events, ketamine continues to be a frontline agent when used with vigilance.
“Safe sedation is not just about the drug — it’s about preparation, presence, and practice.”
