Preanesthetic medication in children: a comparison of oral transmucosal fentanyl citrate versus placebo.

Initial studies have suggested that oral transmucosal fentanyl citrate (OTFC) in a dose of 15-20 micrograms/kg may be a safe and effective preanesthetic medication in children and adults, but this has not been demonstrated in a randomized, double-blind fashion. The purpose of this study was to determine in a randomized, double-blind manner, the efficacy of a lollipop containing fentanyl citrate as a preanesthetic medication before surgery in children. Forty health ASA physical status 1 or 2 children 3-12 yr of age were divided randomly and in double-blind fashion into two groups. Group 1 received the lollipop containing OTFC and group 2 received a placebo lollipop. An appropriate size lollipop was chosen so that if the patient received fentanyl, the total dose would be 15-20 micrograms/kg. Anxiety, sedation, and separation scores were assessed preoperatively and ease of induction was rated. Oxygen saturation and respiratory rate were monitored. Time intervals from preanesthetic to induction and from recovery room (PACU) admission to discharge were noted. Recovery room behavior was assessed upon admission and discharge. Complications and the need for postoperative opioids were noted. OTFC produced significantly more sedation and less anxiety compared with that following placebo. Respiratory rate was significantly decreased in the OTFC group, but oxygen saturation was not significantly different between groups. Anxiety and separation scores and the quality of induction were better in the OTFC group. There was a higher incidence of nausea and pruritus in the fentanyl group. OTFC did not prolong the PACU stay.

RCT Entities:   Population Interventions Outcomes