Oral transmucosal fentanyl citrate (OTFC) for the treatment of postoperative pain.

Author(s): Ashburn MA, Lind GH, Gillie MH, de Boer AJ, Pace NL, Stanley TH

Affiliation(s): Department of Anesthesiology, University of Utah Health Sciences Center, Salt Lake City 84132.

Publication date & source: 1993-02, Anesth Analg., 76(2):377-81.

Publication type: Clinical Trial; Randomized Controlled Trial

Oral transmucosal fentanyl citrate (OTFC) has been used in a variety of clinical situations. This study was designed to determine if OTFC could provide analgesia to patients with acute pain after major surgery. Following written informed consent, 38 ASA Physical Status I-III patients undergoing either a total hip replacement or total knee arthroplasty were studied prospectively. The patients were randomly allocated to receive either OTFC (7-10 micrograms/kg) or a placebo identical in appearance to an OTFC unit. General anesthesia was administered for surgery, and patient-controlled analgesia (PCA) with morphine was initiated in all patients. The PCA interval dose was adjusted to provide adequate analgesia as determined by the patient and physician; the PCA lock-out time 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 hour) 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 being 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 variables were analyzed. Twenty-eight patients completed the study, 13 in the control group and 15 in the OTFC group. There were no significant differences between the study groups as to patients' age, gender, ASA classification, or surgical procedure. In addition, there were no differences between the groups in the number of PCA attempts or delivered dose of morphine during the prestudy or poststudy periods.(ABSTRACT TRUNCATED AT 250 WORDS)