Abstract

Despite their widespread use, the comparative safety and efficacy of chloral hydrate vs. midazolam for sedation of children has not been adequately studied. In a double-blind, randomized trial, we enrolled 40 children, ages 2 mo. to 8 yrs., in an out-patient neuroimaging study. Following informed consent and initial vital signs, children received identically appearing liquids of equal volume of either chloral hydrate (75 mg/kg; max. 2 gm) or midazolam (0.5 mg/kg; max. 10 mg) by mouth. Children were monitored serially for changes in arterial blood pressure, oxygen saturation, pulse, respiration, and anxiety. Efficacy was judged by evaluating the child's readiness for and ability to complete the intended scan. Supplemental dosing was administered for inadequate sedation 30 min after initial medication. Comparisons were performed using chi-square for dichotomous and an unpaired student's t test for continuous data, with significance set at P≤ 0.05. Of 40 enrolled children, 33 completed the protocol, for 13 computerized axial tomography and 20 magnetic resonance imaging studies. Efficacy was significantly improved for the chloral hydrate group, based upon the ability to perform the scan (100% vs. 50% for midazolam) and the need for supplementary dosing (9% vs. 55% for midazolam), P<0.05. Mean duration of sedation was not different (95± 26 min vs. 76 ± 39 for midazolam; P=NS). No physiological deterioration occurred and no oxygen administration or resuscitation was required. We conclude that oral chloral hydrate provides more effective sedation than midazolam for brief neuroimaging studies at these dosages.

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