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

Triazolam has shown promise as a sedative agent for use in pediatric dentistry. However, the efficacy of triazolam has not been previously examined in a placebo-controlled study. The present clinical trial used a two-group, randomized, double-blind study design to compare the efficacy of oral triazolam with that of a placebo. The primary hypothesis tested was that triazolam would reduce negative behaviors of pediatric dental patients compared with a placebo. A secondary hypothesis was that triazolam would increase the efficiency of dental treatment by reducing the need for time-consuming behavior 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), or lactose placebo was given orally 30 min before dental treatment. Behavior management techniques commonly used in pediatric dentistry were used during dental treatment. A single pediatric dentist provided all of the dental treatment. The procedure included an inferior block anesthesia and careful attention to anesthesia effectiveness. All sessions were video-taped and the tapes coded for child and dentist behaviors by an independent observer. There were no statistically significant differences between the groups with respect to completion of dental treatment. There were no significant differences found in either the total time 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 was slightly higher in the placebo than in the drug group due to more time spent preparing the child. Contrary to preliminary reports in the literature, this investigation found little or no improvement in child behavior when triazolam 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 rapport and shaping behavior).

RCT Entities:   Population Interventions Outcomes