The oral transmucosal formulation of fentanyl citrate (OTFC) has been reported to be an effective sedative, providing convenient and atraumatic sedation for children prior to general anesthesia or painful diagnostic procedures. Thirty-three young children (24-60 months of age) scheduled for outpatient general anesthesia for treatment of dental caries were enrolled in this randomized placebo-controlled clinical trial. To determine the effectiveness of the OTFC premedication, patient behavior was evaluated using three distinct outcome ratings. A sedation score rated behavior in the waiting room prior to OTFC as well as 10 minutes and 20 minutes after OTFC. A separation score rated the child's response to being separated from his/her parent or guardian for transport to the dental operatory. Finally, a cooperation score rated the child's acceptance of the mask induction. The OTFC formulation was well tolerated by most of the children in this study. Compared with the placebo oralet, the active OTFC improved behavior for separation from the parent (P < .05) and cooperation with the mask induction (P < .05). The duration of surgery and the time of recovery did not differ between placebo and active premedication. Side effects including respiratory and cardiovascular complications were reported more frequently in the active fentanyl group. Continuous monitoring of respiratory function is essential when using this unique and effective formulation of fentanyl for pediatric preanesthetic sedation.
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