A clinical trial of propofol vs midazolam for procedural sedation in a pediatric emergency department.

OBJECTIVE: To compare the effectiveness, recovery time from sedation, and complication rate of propofol with those of midazolam when used for procedural sedation in the pediatric emergency department (PED).
METHODS: A prospective, blinded, randomized, clinical trial comparing propofol and midazolam was conducted in the PED of a tertiary pediatric center. Eligible patients were aged 2-18 years with isolated extremity injuries necessitating closed reduction. All patients received morphine for pain, then were randomized to receive propofol or midazolam for sedation. Vital signs, pulse oximetry, and sedation scores were recorded prior to sedation and every 5 minutes thereafter until recovery. Recovery time, time from cast completion to discharge, and other time intervals during the PED course and all sedation-related complications were also recorded.
RESULTS: Between August 1996 and October 1997, 91 patients were enrolled. Demographic data, morphine doses, and sedation scores were similar between the propofol and midazolam groups. Mean +/- SD recovery time for the propofol group was 14.9+/-11.1 minutes, compared with 76.4+/-47.5 minutes for the midazolam group, p<0.001. Mild transient hypoxemia was the most significant complication, occurring in 5 of 43 (11.6%) patients given propofol and 5 of 46 (10.9%) patients given midazolam (odds ratio 1.08, 95% CI = 0.24 to 4.76).
CONCLUSION: In this study, propofol induced sedation as effectively as midazolam but with a shorter recovery time. Complication rates for propofol and midazolam were comparable, though the small study population limits the power of this comparison. Propofol may be an appropriate agent for sedation in the PED; however, further study is necessary before routine use can be recommended.

RCT Entities:   Population Interventions Outcomes