[Oral transmucosal fentanyl citrate for the treatment of breakthrough pain. Results of a non-interventional study (NIS)]. / Oral-transmukosales Fentanylcitrat zur Therapie von Durchbruchschmerzen. Ergebnisse einer nichtinterventionellen Studie (NIS).

BACKGROUND: In a non-interventional study the efficacy and tolerability of oral transmucosal fentanyl citrate (OTFC) was studied in patients with opioid-treated cancer pain suffering from breakthrough pain. PATIENTS AND METHODS: The prospective multicenter observational trial included 406 patients. For 3-4 months, efficacy of OTFC treatment for breakthrough pain was documented using a numerical analog pain intensity scale (NAS). Further, OTFC therapy was rated and adverse events were recorded. RESULTS: With application of oral transmucosal fentanyl citrate median pain intensity fell from NAS 8 points at the beginning to NAS 2 points at the end of the study. The median effective dosage was 400 g. Tolerability was rated as good or very good by 87.5% of the patients. CONCLUSION: Oral transmucosal fentanyl citrate is a safe and effective treatment for breakthrough pain in chronic cancer-related pain.