Journal of Dental Research, Vol 78, 1197-1203, Copyright © 1999 by International & American Associations for Dental Research Online Journals
A randomized clinical trial of triazolam in 3- to 5-year-olds
M. Raadal, S. E. Coldwell, T. Kaakko, P. Milgrom, P. Weinstein, V. Perkis and H. W. Karl
Department of Odontology-Pedodontics, Faculty of Dentistry, University of Bergen, Norway.
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).
