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 c omplication rate of propofol with those of midazolam when used for procedur al sedation in the pediatric emergency department (PED). Methods: A prospec tive, blinded, randomized, clinical trial comparing propofol and midazolam was conducted in the FED 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, a nd sedation scores were recorded prior to sedation and every 5 minutes ther eafter until recovery. Recovery time, time from cast completion to discharg e, 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 seda tion scores were similar between the propofol and midazolam groups. Mean +/ - SD recovery time for the propofol group was 14.9 +/- 11.1 minutes, compar ed with 76.4 +/- 47.5 minutes for the midazolam group, p < 0.001. Mild tran sient hypoxemia was the most significant complication, occurring in 5 of 43 (11.6%) patients given propofol and 5 of 46 (10.9%) patients given midazol am (odds ratio 1.08, 95% CI = 0.24 to 4.76). Conclusion: In this study, pro pofol induced sedation as effectively as midazolam but with a shorter recov ery time. Complication rates for propofol and midazolam were comparable, th ough the small study population limits the power of this comparison. Propof ol may be an appropriate agent for sedation in the PED; however, further st udy is necessary before routine use can be recommended.