ORAL TRANSMUCOSAL FENTANYL CITRATE FOR PREMEDICATION OF CHILDREN UNDERGOING LACERATION REPAIR

Study objective: To evaluate the safety and efficacy of two doses of o ral transmucosal fentanyl citrate (OTFC) for premedication of children undergoing laceration repair. Design: Prospective, randomized, nonbli nded study. Setting: Urban pediatric emergency department. Participant s: Thirty children aged 2 to 8 years requiring laceration repair. Inte rventions: Premedication with either 10 to 15 mug/kg or 15 to 20 mug/k g of OTFC. Results: Activity score, vital signs, oxygen saturation, an d pain scores were recorded before and after administration of OTFC. A ctivity scores decreased significantly 15 to 60 minutes after OTFC. Th e physician suturing the wound rated the child's sedation/pain control as excellent or good in 83% of patients. Vital signs changes were not clinically remarkable. Oxygen saturations remained at 95% or more exc ept in one child who experienced a transient decrease to 91%. Adverse effects were not serious but included vomiting in 20% of the lower-dos e group and 47% of the higher-dose group. There were no significant di fferences between dose groups for activity or pain score changes, phys ician assessment, discharge times, or adverse events. Conclusion: Both doses of OTFC reduced activity with comparable efficacy, with no seri ous vital signs changes. However, the higher-dose group had a greater number (P = NS) of adverse effects.