J D'Agostino1, T E Terndrup. 1. Department of Emergency Medicine, State University of New York Health Science Center at Syracuse, 13210, USA. dagostinj@mailbox.hscsyr.edu
Abstract
OBJECTIVE: The comparative safety and efficacy of chloral hydrate and midazolam for sedation of children has not been adequately studied. METHODS: In a double-blind randomized trial, at a single university hospital, we enrolled 40 children, ages 2 months to 8 years, in an out-patient neuroimaging study. Children judged to require sedation were enrolled during a 14-month period ending August 1995. They received identically appearing liquids of equal volume of either chloral hydrate (75 mg/kg, maximum 2 g) or midazolam (0.5 mg/kg, maximum 10 mg) by mouth. Children were monitored for changes in arterial blood pressure, oxygen saturation, pulse, respiration and anxiety. Efficacy was judged by evaluating the child's ability to complete the intended scan. Supplemental dosing was administered to children who were judged inadequately sedated 30 minutes after the initial medication. RESULTS: Interim analysis demonstrated a significant sedation failure rate. Of 40 enrolled children, 33 completed the protocol. Efficacy was significantly improved for the chloral hydrate group for both ability to perform the scan, chloral hydrate = 11/11 (100%, 95% CI = 72-100) vs. midazolam = 11/22 (50%, 95% CI = 29-71), and the need for supplementary dosing, chloral hydrate = 1/11 (9%, 95% CI = 0-26) vs midazolam = 12/22 (55%, 95% CI = 34-76), P<0.05. Mean duration of sedation was not significantly different. No physiological deterioration occurred and no oxygen administration was required. CONCLUSIONS: We conclude that, in these doses, oral chloral hydrate may provide more effective sedation than midazolam for brief neuroimaging studies in young children.
RCT Entities:
OBJECTIVE: The comparative safety and efficacy of chloral hydrate and midazolam for sedation of children has not been adequately studied. METHODS: In a double-blind randomized trial, at a single university hospital, we enrolled 40 children, ages 2 months to 8 years, in an out-patient neuroimaging study. Children judged to require sedation were enrolled during a 14-month period ending August 1995. They received identically appearing liquids of equal volume of either chloral hydrate (75 mg/kg, maximum 2 g) or midazolam (0.5 mg/kg, maximum 10 mg) by mouth. Children were monitored for changes in arterial blood pressure, oxygen saturation, pulse, respiration and anxiety. Efficacy was judged by evaluating the child's ability to complete the intended scan. Supplemental dosing was administered to children who were judged inadequately sedated 30 minutes after the initial medication. RESULTS: Interim analysis demonstrated a significant sedation failure rate. Of 40 enrolled children, 33 completed the protocol. Efficacy was significantly improved for the chloral hydrate group for both ability to perform the scan, chloral hydrate = 11/11 (100%, 95% CI = 72-100) vs. midazolam = 11/22 (50%, 95% CI = 29-71), and the need for supplementary dosing, chloral hydrate = 1/11 (9%, 95% CI = 0-26) vs midazolam = 12/22 (55%, 95% CI = 34-76), P<0.05. Mean duration of sedation was not significantly different. No physiological deterioration occurred and no oxygen administration was required. CONCLUSIONS: We conclude that, in these doses, oral chloral hydrate may provide more effective sedation than midazolam for brief neuroimaging studies in young children.