A randomized clinical trial of triazolam in 3-to 5-year-olds

Triazolam has shown promise as a sedative agent for use in pediatric dentis try. However, the efficacy of triazolam has not been previously examined in a placebo-controlled study. The present clinical trial used a two-group, r andomized, double-blind study design to compare the efficacy of oral triazo lam with that of a placebo. The primary hypothesis tested was that triazola m would reduce negative behaviors of pediatric dental patients compared wit h a placebo. A secondary hypothesis was that triazolam would increase the e fficiency of dental treatment by reducing the need for time-consuming behav ior management by the pediatric dentist. The subjects were 54 3- to 5-year- old children, randomly assigned to the drug and placebo groups. The active drug, 0.03 mg/kg triazolam (Halcion(R)), or lactose placebo was given orall y 30 min before dental treatment. Behavior management techniques commonly u sed in pediatric dentistry were used during dental treatment. A single pedi atric dentist provided all of the dental treatment. The procedure included an inferior block anesthesia and careful attention to anesthesia effectiven ess. All sessions were videotaped and the tapes coded for child and dentist behaviors by an independent observer. There were no statistically signific ant differences between the groups with respect to completion of dental tre atment. There were no significant differences found in either the total tim e or the percent of time that the subjects exhibited disruptive movements, verbal or non-verbal distress. The total use of time in the dental chair wa s slightly higher in the placebo than in the drug group due to more time sp ent preparing the child. Contrary to preliminary reports in the literature, this investigation found little or no improvement in child behavior when t riazolam was used as a sedative compared with a placebo. However, triazolam did shorten the length of dental treatment, primarily by reducing dentist time in preparing the child for the dental procedure (e.g., establishing ra pport and shaping behavior).