title: An open label study of oral transmucosal fentanyl citrate (OTFC) for the treatment of breakthrough cancer pain.
abstract: Ten patients with advanced cancer and breakthrough pain between the ages of 39 and 78 received oral transmucosal fentanyl citrate (10-15 micrograms/kg) 4 or 5 times each over 2 days (42 total administrations) in an open study. Baseline vital sign and rating scale results did not vary over administrations, except for heart rate which showed an 8 beats/min decrease over 4 administrations. Heart rate and oxygen saturation did not vary significantly over 120 min of evaluation, and minimal changes in blood pressure and respiration rate were found. Significant reduction in pain scores as measured by a pain descriptive scale, the McGill-Melzack scale, and a numeric (VAS) scale were seen at all evaluations from 5 to 120 min. Average time to onset of pain relief was 9.5 min after administration. Wellbeing was significantly increased at all evaluations. Activity level as recorded by the investigator was significantly reduced from 10 to 30 min after administration, however, activity level as reported by the patient was significantly increased at 5 min and from 60 to 120 min after OTFC administration. There were no significant adverse effects.
authors.affiliation: Department of Anesthesiology, Pain Management Center, University of Utah Health Sciences Center, Salt Lake City, UT 84132 U.S.A. School of Medicine, University of Leiden, LeidenThe Netherlands.
authors.forename: Perry G
authors.initials: PG
authors.lastname: Fine
authors.forename: Marco
authors.initials: M
authors.lastname: Marcus
authors.forename: Just A
authors.initials: JA
authors.lastname: De Boer
authors.forename: Bianca
authors.initials: B
authors.lastname: Van der Oord
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D001794:Blood Pressure; D005283:Fentanyl / Q000008:administration & dosage* / Q000627:therapeutic use; D006801:Humans; D008875:Middle Aged; D009061:Mouth Mucosa; D009369:Neoplasms / Q000503:physiopathology*; D010147:Pain Measurement; D010148:Intractable Pain / Q000188:drug therapy* / Q000503:physiopathology; D013997:Time Factors
chemical_list: D005283:Fentanyl