Effects of anesthetic technique on side effects associated with fentanyl Oralet premedication.

Author(s): Malviya S, Voepel-Lewis T, Huntington J, Siewert M, Green W

Affiliation(s): Department of Anesthesiology, University of Michigan Medical Center, Ann Arbor 48109-0211, USA.

Publication date & source: 1997-08, J Clin Anesth., 9(5):374-8.

Publication type: Clinical Trial; Randomized Controlled Trial

STUDY OBJECTIVES: To evaluate the efficacy of 5 to 10 micrograms/kg of oral transmucosal fentanyl citrate (OTFC) as an anesthetic premedication, and to determine whether propofol induction reduces postoperative nausea and vomiting (PONV) in pediatric patients premedicated with OTFC undergoing outpatient surgery. DESIGN: Prospective, randomized, double-blinded study. SETTINGS: University of Michigan Health Care Systems and University of Arizona. PARTICIPANTS: 62 ASA physical status I and II children aged 4 to 14 years (8.9 +/- 0.5 years). INTERVENTIONS: Subjects were randomly assigned to one of four groups: (1) OTFC premedication and halothane induction; (2) OTFC premedication and propofol induction; (3) placebo premedication and halothane induction; and (4) placebo premedication and propofol induction. OTFC or placebo was administered 30 minutes prior to induction, and activity (sedation), apprehension, and cooperation scores were recorded before, at 15 and 30 minutes after study drug, and on induction. All perioperative adverse events were recorded. MEASUREMENTS AND MAIN RESULTS: Children who received OTFC became drowsier and had a significant change from baseline in combined activity, apprehension, and cooperation scores, whereas those who received placebo became less cooperative at induction. Patients who received OTFC experienced more adverse events overall (p < 0.001) than patients who received placebo. Additionally, OTFC patients experienced more vomiting (p < 0.001) and pruritus (p = 0.049) than controls. The incidence of PONV in patients who received OTFC and halothane induction was 50%, compared to 30% in patients receiving OTFC and a propofol induction (p = NS). CONCLUSIONS: OTFC in doses of 5 to 10 micrograms/kg was effective in producing sedation and facilitating cooperation with induction; however, it was associated with significant PONV in our study. Although propofol induction did not significantly reduce PONV in our study, further study with a larger sample, and with propofol as the sole anesthetic, may be warranted.