SAFETY AND EFFICACY OF ORAL TRIAZOLAM IN CHILDREN

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The safety and efficacy of most oral benzodiazepines for sedation of children is unknown. Yet, there is ample evidence that adverse events occur with unfortunate regularity during sedation in dental care settings with children. This study is a randomized double blind clinical trial where 96 three-to-five year-old children are assigned to either active drug (o.015 or 0.03 mg/kg) or placebo before dental treatment. The objective of the research is to establish the efficacy, safety, and optimal dosing regimen for oral triazolam in pediatric sedation, a paradigm for surgical premedication, in order to provide a rational clinical pharmacological basis for the use this drug which is commonly used yet currently unapproved. The specific aims are: a. To determine the efficacy of oral triazolam administered as a premedication to children in dental practice in comparison to a placebo. b. To assess the safety of oral triazolam in children. c. To study visual and memory side effects of triazolam in children.