Dose-titration, multicenter study of oral transmucosal fentanyl citrate for the treatment of breakthrough pain in cancer patients using transdermal fentanyl for persistent pain

Purpose: Supplemental, "as needed," administration of an opioid is a common approach to the problem of breakthrough pain in cancer patients. Oral transmucosal fentanyl citrate (OTFC) is undergoing investigation as a new treatment for breakthrough pain. The primary purpose of the study wets to demonstrate that ct single-unit dose of OTFC can safely and effectively treat break through pain. A secondary goal was to determine appropriate dosing guidelines. Patients and Methods: This was a multicenter, randomized, double-blind,dose-titration study in 62 adult cancer patients using transdermal fentanyl for persistent pain. Consenting patients provided 2 days of base line data to evaluate the performance of their usual breakthrough pain medication. Patients then randomly received 200 mu g or 400 mu g OTFC in double-blind fashion. (Patients were always assigned, rather than randomized, to 200 mu g if 400 mu g represented > 20% of around-the-clock medication.) Pain intensity (PI), pain relief (PR), and global satisfaction scores were recorded, OTFC was then titrated until the patient received adequate PR for each episode using one OTFC unit, Orders to titrate vp were ignored one third of the time to improve the blind. Two days of baseline data were compared with 2 days of OTFC data after titration identified an effective dose of OTFC, Results: Most patients (76%) found a safe and effective dose of OTFC, There was no meaningful relationship between the around-the-clack opioid regimen and the effective dose of OTFC, In open-label comparisons, OTFC produced a faster onset of relief and a greater degree of PR than patients' usual breakthrough medication. Somnolence, nausea, and dizziness were the most common side effects associated with OTFC, Conclusion: Most patients find a single OTFC dosage that adequately treats breakthrough pain. The optimal dose is found by titration and is not predicted by around-the-clack dose of opioids, (C) 1998 by American Society of Clinical Oncology.