A double-blind randomized controlled trial investigating the effectiveness of topical bupivacaine in reducing distress in children following extractions under general anaesthesia

Objective. This study was designed to investigate the effectiveness of topical bupivacaine (0.25%) in reducing postoperative distress following extraction of teeth under general anaesthesia in children. Design. The study was a double-blind randomized controlled trial. Setting. The study was conducted in a dental hospital. Sample. The sample comprised 135 children aged between 2 and 12 years of age who were undergoing outpatient general anaesthesia for simple dental extractions. Methods. The children were randomly allocated to one of two groups: the bupivacaine group (the study group) comprised 68 children whilst the sterile water group (the control group) comprised 67. Following the extraction of their teeth, children had swabs soaked in the appropriate solution placed over the exposed teeth sockets. A five-point face scale was employed by an independent observer to evaluate the distress for each child. Evaluation of distress was made preoperatively, on recovery from the general anaesthetic, and again, 15 min following recovery from the anaesthetic. Results. There were no statistically significant differences between the mean distress scores for the bupivacaine and sterile water groups preoperatively, postoperatively or 15 min postoperatively. For both groups, however, there were significant increases in distress scores between the preoperative and 15 min postoperative assessment scores. Conclusion. Extraction of teeth under general anaesthesia does cause distress in children. There is no evidence that topical bupivacaine reduces this distress when compared to sterile water.