A Blinded, Randomized Controlled Trial to Evaluate Ketamine/Propofol Versus Ketamine Alone for Procedural Sedation in Children

Abstract

The primary objective is to compare total sedation time when ketamine/propofol is used compared with ketamine alone for pediatric procedural sedation and analgesia. Secondary objectives include time to recovery, adverse events, efficacy, and satisfaction scores. Children (aged 2 to 17 years) requiring procedural sedation and analgesia for management of an isolated orthopedic extremity injury were randomized to receive either ketamine/propofol or ketamine. Physicians, nurses, research assistants, and patients were blinded. Ketamine/propofol patients received an initial intravenous bolus dose of ketamine 0.5 mg/kg and propofol 0.5 mg/kg, followed by propofol 0.5 mg/kg and saline solution placebo every 2 minutes, titrated to deep sedation. Ketamine patients received an initial intravenous bolus dose of ketamine 1.0 mg/kg and Intralipid placebo, followed by ketamine 0.25 mg/kg and Intralipid placebo every 2 minutes, as required. One hundred thirty-six patients (67 ketamine/propofol, 69 ketamine) completed the trial. Median total sedation time was shorter (P=0.04) with ketamine/propofol (13 minutes) than with ketamine (16 minutes) alone (Δ -3 minutes; 95% confidence interval [CI] -5 to -2 minutes). Median recovery time was faster with ketamine/propofol (10 minutes) than with ketamine (12 minutes) alone (Δ -2 minutes; 95% CI -4 to -1 minute). There was less vomiting in the ketamine/propofol (2%) group compared with the ketamine (12%) group (Δ -10%; 95% CI -18% to -2%). All satisfaction scores were higher (P<0.05) with ketamine/propofol. When compared with ketamine alone for pediatric orthopedic reductions, the combination of ketamine and propofol produced slightly faster recoveries while also demonstrating less vomiting, higher satisfaction scores, and similar efficacy and airway complications.