Oral transmucosal fentanyl citrate for preanaesthetic medication of paediatric cardiac surgery patients.

The safety and efficacy of oral transmucosal fentanyl citrate (OTFC) as a preanaesthetic medication were evaluated in 42 children aged two to twelve years scheduled to undergo general anaesthesia for open cardiac surgery. Patients were randomly assigned to receive either a placebo lozenge or a lozenge of 15-20 micrograms.kg-1) OTFC 45 min preoperatively and were managed in a double-blinded manner. Heart rate, respiratory rate (RR), blood pressure, and digital pulse oximetry (SpO2) were monitored throughout the study. Scoring systems were utilized to evaluate sedation, anxiety, cooperation, and ease and quality of parental separation and anaesthetic induction. Adverse effects were noted. Preoperatively, sedation was observed in both groups, but children receiving OTFC had significantly less distress at time of separation from parents. Clinically significant less distress at and SpO2 were observed more frequently in children in the OTFC group than in the placebo group. The authors conclude that, in paediatric cardiac surgical patients, OTFC induces preoperative sedation and facilitates separation of the patients from their parents, but is associated with decreases in respiratory rate and SpO2 that may be of clinical importance.

RCT Entities:   Population Interventions Outcomes