ORAL TRANSMUCOSAL FENTANYL CITRATE (OTFC) FOR THE TREATMENT OF POSTOPERATIVE PAIN

Oral transmucosal fentanyl citrate (OTFC) has been used in a variety o f clinical situations. This study was designed to determine if OTFC co uld provide analgesia to patients with acute pain after major surgery. Following written informed consent, 38 ASA Physical Status I-III pati ents undergoing either a total hip replacement or total knee arthropla sty were studied prospectively The patients were randomly allocated to receive either OTFC (7-10 mug/kg) or a placebo identical in appearanc e to an OTFC unit. General anesthesia was administered for surgery, an d patient-controlled analgesia (PCA) with morphine was initiated in al l patients. The PCA interval dose was adjusted to provide adequate ana lgesia as determined by the patient and physician; the PCA lock-out ti me was not changed. On the morning after surgery, the most recent 12 h of PCA data (milligrams per hour of morphine and PCA attempts per hou r) were recorded. OTFC or placebo units were administered at times 0, 4, and 8 h during a 12-h study, resulting in three identical units bei ng completely consumed. PCA data, as well as incidence and severity of any adverse side effects, were recorded during the study and for the next 12 h. Treatment groups were compared for similarity, and study va riables were analyzed. Twenty-eight patients completed the study, 13 i n the control group and 15 in the OTFC group. There were no significan t differences between the study groups as to patients' age, gender, AS A classification, or surgical procedure. In addition, there were no di fferences between the groups in the number of PCA attempts or delivere d dose of morphine during the prestudy or poststudy periods. However, there was a significant decrease in the amount of morphine delivered t o the OTFC group via the PCA device compared to the placebo group duri ng the study period. There were no differences in the incidence or sev erity of adverse side effects between the two groups. OTFC reduces the requirements for other analgesics in patients with acute pain followi ng major orthopedic surgery. Within the settings of this study, 1 mg o f OTFC appears to be as potent as 5 mg of intravenous morphine sulfate .