The effect of premedication with OTFC, with or without ondansetron, on postoperative agitation, and nausea and vomiting in pediatric ambulatory patients

Background: The purpose of this study was to evaluate, in the pediatric ambulatory surgical population, the efficacy of: (i) oral transmucosal fentanyl citrate (OTFC), when given preoperatively, to reduce postoperative excitement associated with sevoflurane, and (ii) intravenous ondansetron to reduce postoperative nausea and vomiting (PONV) associated with OTFC. Methods: This randomized, double-blinded, placebo controlled study evaluated the efficacy of OTFC [normal dose (ND) = 10-15 mug.kg(-1) or low dose = 100 mug] compared with placebo in the prevention of postoperative agitation; and the efficacy of ondansetron (0.1 mg.kg(-1) to 4 mg) compared with placebo to reduce PONV associated with OTFC. Results: There were 125 patients evaluated (2-10 years old, ASA class I or II and weight 10-40 kg). Preoperatively OTFC was associated with an increased likelihood of cooperation at baseline (P = 0.018). Postoperatively there was a higher incidence of vomiting in children that received OTFC. The anxiety/agitation of patients entering the PACU was significantly less in children who received OTFC ND (P < 0.001). This effect decreased over time. Patients with respiratory adverse events related to the study drug were significantly higher in groups who received OTFC, however, they were not of clinical significance. OTFC was associated with delays in time for eligibility to PACU discharge (P = 0.003). Conclusions: Even though OTFC reduced early postoperative agitation the increase in side effects, namely PONV and prolonged recovery times, limits its clinical usefulness. The study demonstrates the tradeoffs between anxiety and agitation vs vomiting, respiratory events and prolonged recovery times. Ambulatory pediatric patients undergoing procedures in which opioids would be routinely used might benefit the most from OTFC combined with ondansetron as part of the anesthetic technique.