STUDY OBJECTIVE: To evaluate the safety and efficacy of two doses of oral transmucosal fentanyl citrate (OTFC) for premedication of children undergoing laceration repair. DESIGN: Prospective, randomized, nonblinded study. SETTING:Urban pediatric emergency department. PARTICIPANTS: Thirty children aged 2 to 8 years requiring laceration repair. INTERVENTIONS: Premedication with either 10 to 15 micrograms/kg or 15 to 20 micrograms/kg of OTFC. RESULTS:Activity score, vital signs, oxygen saturation, and pain scores were recorded before and after administration of OTFC. Activity scores decreased significantly 15 to 60 minutes after OTFC. The 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 except in one child who experienced a transient decrease to 91%. Adverse effects were not serious but included vomiting in 20% of the lower-dose group and 47% of the higher-dose group. There were no significant differences between dose groups for activity or pain score changes, physician assessment, discharge times, or adverse events. CONCLUSION: Both doses of OTFC reduced activity with comparable efficacy, with no serious vital signs changes. However, the higher-dose group had a greater number (P = NS) of adverse effects.
RCT Entities:
STUDY OBJECTIVE: To evaluate the safety and efficacy of two doses of oral transmucosal fentanyl citrate (OTFC) for premedication of children undergoing laceration repair. DESIGN: Prospective, randomized, nonblinded study. SETTING: Urban pediatric emergency department. PARTICIPANTS: Thirty children aged 2 to 8 years requiring laceration repair. INTERVENTIONS: Premedication with either 10 to 15 micrograms/kg or 15 to 20 micrograms/kg of OTFC. RESULTS: Activity score, vital signs, oxygen saturation, and pain scores were recorded before and after administration of OTFC. Activity scores decreased significantly 15 to 60 minutes after OTFC. The 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 except in one child who experienced a transient decrease to 91%. Adverse effects were not serious but included vomiting in 20% of the lower-dose group and 47% of the higher-dose group. There were no significant differences between dose groups for activity or pain score changes, physician assessment, discharge times, or adverse events. CONCLUSION: Both doses of OTFC reduced activity with comparable efficacy, with no serious vital signs changes. However, the higher-dose group had a greater number (P = NS) of adverse effects.