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 micrograms/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.(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes