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A randomized double-blinded trial of chloral hydrate with or without hydroxyzine versus placebo for pediatric dental sedation.

Chloral hydrate and hydroxyzine are a drug combination frequently used by practitioners to sedate pediatric dental patients, but their effectiveness has not been compared to a negative control group in humans. The aim of this crossover, double-blinded study was to evaluate the effect of these drugs compared to a placebo, administered to young children for dental treatment. Thirty-five dental sedation sessions were carried out on 12 uncooperative ASA I children aged less than 5 years old. In each session patients were randomly assigned to groups P (placebo), CH (chloral hydrate 75 mg/kg) and CHH (chloral hydrate 50 mg/kg plus hydroxyzine 2.0 mg/kg). Vital signs and behavioral variables were evaluated every 15 min. Comparisons were statistically analyzed using Friedman and Wilcoxon tests. P, CH and CHH had no differences concerning vital signs, except for breathing rate. All vital signs were in the normal range. CH and CHH promoted more sleep in the first 30 min of treatment. Overall behavior was better in CH and CHH than in P. CH, CHH and P were effective in 62.5%, 61.5% and 11.1% of the cases, respectively. Chloral hydrate was safe and relatively effective, causing more satisfactory behavioral and physiological outcomes than a placebo.