Randomized clinical trial of propofol versus methohexital for procedural sedation during fracture and dislocation reduction in the emergency department.

UNLABELLED: Although methohexital has been well studied for use in emergency department (ED) procedural sedation (PS), propofol has been evaluated less extensively for ED use.
OBJECTIVE: The authors hypothesized that there is no difference in the depth of sedation and the rate of respiratory depression (RD) between propofol and methohexital in PS during the reduction of fractures and dislocations in the ED.
METHODS: This was a randomized prospective study of nonintoxicated adult patients undergoing PS for fracture or dislocation reduction in the ED between July 2001 and March 2002. Patients were randomized to receive either propofol or methohexital, 1 mg/kg intravenously, followed by repeat boluses of 0.5 mg/kg every 2 minutes until adequate sedation was achieved. Doses, vital signs, end-tidal CO(2) (ETCO(2)) by nasal cannulae, pulse oximetry, and bispectral electroencephalogram analysis (BIS) scores were recorded. RD was defined as an ETCO(2) greater than 50 torr, an oxygen saturation less than 90% at any time, or an absent ETCO(2) waveform. After returning to baseline mental status, patients completed three 100-mm visual analog scales (VASs) regarding pain associated with the procedure, recall of the procedure, and satisfaction. RD rates and VAS outcomes were compared with chi-square tests.
RESULTS: There were 109 patients enrolled; six were excluded for study protocol violations. Of the remaining 103 patients, 52 received methohexital (reduction successful in 94%) and 51 received propofol (98% successful). No cardiac rhythm abnormalities or significant decline in systolic blood pressure (>20%) was detected. Six patients required bag-valve-mask-assisted ventilations during the procedure, all for less than 1 minute; four of these patients received methohexital, and two received propofol. By the authors' definition, RD was seen in 25 of 52 (48%) patients receiving methohexital and 25 of 51 (49%) patients receiving propofol (p = 0.88). The mean minimum recorded BIS score was 66.2 (95% confidence interval [CI] = 62 to 70) for methohexital and 66 (95% CI = 60 to 71) for propofol. VAS results showed similar rates of reported pain, recall, and satisfaction for the two agents.
CONCLUSIONS: The authors were unable to detect a significant difference in the level of subclinical RD or the level of sedation by BIS between the two agents. The use of either agent seems to be safe in the ED.

RCT Entities:   Population Interventions Outcomes