The Effects of Oral Transmucosal Fentanyl Citrate Premedication on Preoperative Behavioral Responses and Gastric Volume and Acidity in Children

The authors compared the safety, efficacy, and effects on gastric volume and pH of oral transmucosal fentanyl citrate (OTFC) premedication and of placebo lollipop and no premedication in 55 children undergoing elective operations. The patients were randomly assigned to receive no premedication (group A, N = 18); OTFC containing 15–20 μg/kg of fentanyl citrate (group B, N = 18); or a placebo lollipop (group C, N = 19). Activity (sedation) and anxiety scores, vital signs (including systolic and diastolic arterial blood pressures, heart and respiratory rates), and pulse oximetry determined oxygen saturation were measured before and at 10-min intervals after premedication until the patients were taken to the operating room. Gastric contents were aspirated via an orogastric tube and analyzed for volume and pH after induction of anesthesia. Quality of induction and recovery were evaluated using scoring schedules; recovery times were measured and side effects recorded. OTFC was readily accepted and provided levels of sedation and anxiolysis significantly greater after 10 min than after no premedication or the placebo lollipop. Arterial blood pressures, heart rate, and oxygen saturations were not different among the three groups. In patients given OTFC, respiratory rates were significantly lower after 10 min than they were in patients having no premedication. When compared to patients having no premedication, patients having OTFC had slightly increased gastric volumes (14.6 ± 10 vs 7.6 ± 5.3 mL, mean ± SD). Patients having a placebo lollipop had similar gastric volumes (15.6 ± 13.5 mL) as those having OTFC. The three groups had similar gastric pH's (1.69 ± 0.31, 1.92 ± 0.53 and 1.72 ± 0.28, mean ± SD, groups A, B, and C, respectively). Induction and recovery evaluations and recovery times were also similar in the three groups. OTFC was associated with a 50% incidence of mild, nondisturbing, preoperative facial pruritus and a higher overall incidence of postoperative nausea (44%) than was premedication with the placebo lollipop (16%) or no premedication (0%). The results demonstrate that OTFC is readily accepted, safe, and more effective than no premedication or premedication with a placebo lollipop, and does not affect gastric pH but does increase gastric volume.