A randomized, controlled trial of IV versus IM ketamine for sedation of pediatric patients receiving emergency department orthopedic procedures

Study objective: We compare adverse events, efficacy, and length of sedation of intravenous (IV) versus intramuscular (IM) ketamine procedural sedation and analgesia for orthopedic procedures in the emergency department (ED). Methods: Pediatric patients receiving ketamine for orthopedic procedures were enrolled in a prospective, randomized, controlled trial in a children's hospital ED. All patients were initially randomized to receive ketamine either 1 mg/kg IV or 4 mg/kg IM. Demographics, adverse events, sedation efficacy, and length of sedation were recorded. Results: Two hundred twenty-five patients were randomized (116 IV, 109 IM). Two hundred eight patients, aged 14 months to 15 years, completed the study, 109 IV and 99 IM. Respiratory adverse events were similar between groups (IV 8.3% versus IM 4.0%; odds ratio [OR] 0.47; 95% confidence interval [CI] 0.14 to 1.6). Vomiting in the ED was more common in the IM group (26.3% versus 11.9%; OR 2.60; 95% Cl 1.2 to 5.9). Using the Faces Pain Scale, patients in the IM group reported significantly less pain from the procedure. Video observers reported significantly lower distress in the IM group during the painful procedure (Observation Score of Behavioral Distress scores 0.35 IM versus 0.74 IV; mean difference 0.38; 95% Cl 0.04 to 0.72). Length of sedation was significantly longer in the IM group (median 129 versus 80 minutes). Satisfaction of sedation was high in parents and physicians, with no difference in reported satisfaction between groups. This study was terminated early because of nursing resistance based on the longer recovery times observed in patients receiving ketamine IM. Conclusion: In this study of pediatric sedation for orthopedic procedures, we found that ketamine 4 mg/kg IM was more effective than 1 mg/kg IV but demonstrated significantly longer recovery times and more vomiting.