THE USE OF ORAL TRANSMUCOSAL FENTANYL CITRATE FOR PAINFUL PROCEDURES IN CHILDREN

Objective. To investigate the efficacy and safety of oral transmucosal fentanyl (OTFC) in providing analgesia and sedation for painful diagn ostic procedures in children. Design. Randomized, placebo-controlled c linical trial. Method. Forty-eight children referred to the University of Connecticut Division of Pediatric Hematology/Oncology for bone mar row aspiration or lumbar puncture were randomized to receive either OT FC (15 to 20 mu g/kg) or a placebo lollipop. Thirty minutes after admi nistration, the procedure was begun. An anesthesiologist monitored the child's heart rate, blood pressure, and oxygen saturation every 10 mi nutes. At the conclusion of the procedure, the nurse, the child's pare nt, and all children over 8 years of age were asked to rate the pain a ssociated with the procedure using a 1 to 10 visual analogue scale. Yo ung children (less than 8) used a modified scale, the Oucher, yielding a 0 to 5 score. Results. Significant differences in pain ratings betw een the OTFC and placebo groups were noted on the pain scores of the p arents (P =.005), nurses (P =.001), younger children (P =.006), and ol der children (P =.013), and median pain scores in the OTFC group were reduced to tolerable levels. Vomiting (P =.003) and itching (P =.001) were more common in the OTFC group, but no clinically significant vita l sign deviations occurred. Conclusion. OTFC is safe and effective for use in relieving the pain of pediatric procedures, but frequency of v omiting may restrict its clinical usefulness.