Effi cacy and safety of premedication with single dose of oral pregabalin in children with dental anxiety: A randomized double-blind placebo-controlled crossover clinical trial

Abstract

Background: Dental anxiety is a relatively frequent problem that can lead to more serious problems

such as a child entering a vicious cycle as he/she becomes reluctant to accept the required dental

treatments. The aim of this randomized double-blind clinical trial study was to evaluate the anxiolytic

and sedative effect of pregabalin in children.

Materials and Methods: Twenty-fi ve children were randomized to a double-blind placebocontrolled

crossover clinical trial. Two visits were scheduled for each patient. At the fi rst visit, 75 mg

pregabalin or placebo was given randomly, and the alternative was administered at the next visit.

Anxiolytic and sedative effects were measured using the visual analogue scale. The child’s behavior

was rated with the Frankl behavioral rating scale and the sedation level during the dental procedure

was scored using the Ramsay sedation scale. The unpaired, two-tailed Student’s t-test was used to

compare the mean changes of visual analog scale (VAS) for anxiety in the pregabalin group with

that of the placebo group. A repeated measures MANOVA model was used to detect differences in

sedation level in the pregabalin and placebo groups regarding the interaction of 3-time measurements;

sub-group analysis was performed using Student’s t-test. The Mann–Whitney U-test was used to

analyze the nonparametric data of the Frankl and Ramsay scales. A P < 0.05 was considered signifi cant.

Results: The reduction of the VAS-anxiety score from 2 h post-dose was statistically signifi cant in

the pregabalin group. From 2 h to 4 h post-dose, the VAS-sedation score increased signifi cantly in the

pregabalin group. The child’s behavior rating was not signifi cantly different between the groups. The number

of “successful” treatment visits was higher in the pregabalin group compared to the placebo group.

Conclusion: Signifi cant anxiolytic and sedative effects can be anticipated 2 h after oral administration

of pregabalin without serious side effects.

Key Words: Anxieties, dental anxiety, sedatives