OBJECTIVE: To compare sedation outcomes for chloral hydrate (CH) and midazolam (MD) as sedative agents for diagnostic procedures in children. METHODS: A prospective, randomized, double-blinded study conducted between July 2005 and October 2006, at the Pediatric Day Care Unit (DCU), King Abdulaziz Medical City, Riyadh, Saudi Arabia. After meeting the inclusion criteria and getting informed consent, patients were randomized, given the study drug, and monitored for sedation outcomes. RESULTS:Two hundred and seventy-five patients who had 292 sedation sessions for diagnostic procedures were included in the study. Due to missing data, 286 sedations were included in the final analysis; 144 in the CH and 142 in the MD group. Both groups were comparable with respect to demographic and baseline characteristics. The CH compared to MD group, had a higher sedation success rate, shorter time to achieve sedation, shorter length of stay in DCU, and longer sedation duration. In both study groups, patients who required a second dose tended to be older and heavier. No major side effects were encountered. The CH group had a significantly higher mean sedation scores at 15, 30, 45, and 60 minutes. CONCLUSION: Chloral hydrate compared to MD, had a shorter time to achieve sedation, a higher success rate, less need for a second dose, and decreased the time spent in the DCU. Older and heavier patients are more likely to require a second dose of the study drug to be sedated.
RCT Entities:
OBJECTIVE: To compare sedation outcomes for chloral hydrate (CH) and midazolam (MD) as sedative agents for diagnostic procedures in children. METHODS: A prospective, randomized, double-blinded study conducted between July 2005 and October 2006, at the Pediatric Day Care Unit (DCU), King Abdulaziz Medical City, Riyadh, Saudi Arabia. After meeting the inclusion criteria and getting informed consent, patients were randomized, given the study drug, and monitored for sedation outcomes. RESULTS: Two hundred and seventy-five patients who had 292 sedation sessions for diagnostic procedures were included in the study. Due to missing data, 286 sedations were included in the final analysis; 144 in the CH and 142 in the MD group. Both groups were comparable with respect to demographic and baseline characteristics. The CH compared to MD group, had a higher sedation success rate, shorter time to achieve sedation, shorter length of stay in DCU, and longer sedation duration. In both study groups, patients who required a second dose tended to be older and heavier. No major side effects were encountered. The CH group had a significantly higher mean sedation scores at 15, 30, 45, and 60 minutes. CONCLUSION:Chloral hydrate compared to MD, had a shorter time to achieve sedation, a higher success rate, less need for a second dose, and decreased the time spent in the DCU. Older and heavier patients are more likely to require a second dose of the study drug to be sedated.