Comparison of chloral hydrate and midazolam by mouth as premedicants in children undergoing otolaryngological surgery.

Chloral hydrate 25, 50 or 75 mg kg-1 or midazolam 0.4, 0.5 or 0.6 mg kg-1, all given by mouth in combination with atropine 0.03 mg kg-1, were compared as premedication in 248 children in a randomized, double-blind study. Chloral hydrate was significantly less palatable than midazolam. The anxiolytic effect of chloral hydrate 75 mg kg-1 was "good" in children younger than 5 yr, whereas the other doses of chloral hydrate, and all doses of midazolam, provided only "fair" anxiolysis in this age group. All doses of both premedicants provided good anxiolysis in the older children. A satisfactory antisialogogue effect was seen in 83-90% of each group. About 20 min after extubation, restlessness was observed in 15-25% of the younger children premedicated with chloral hydrate 25 mg kg-1 or with midazolam 0.4 or 0.6 mg kg-1. The mean total recovery score (0-10) based on activity, ventilation, heart rate, conscious level and colour ranged between 5.8 and 6.8 at 10 min and between 9 and 9.5 at 70 min after extubation in all groups. Midazolam 0.5 mg kg-1 is recommended for children less than 5 yr of age and midazolam 0.4-0.5 mg kg-1 for older ones. Chloral hydrate 75 mg kg-1 provided good anxiolysis in both age groups; however, it was less palatable than the midazolam.

RCT Entities:   Population Interventions Outcomes