title: Sublingual administration of fentanyl to cancer patients is an effective treatment for breakthrough pain: results from a randomized phase II study.
abstract: In this study we evaluated the efficacy and tolerability of sublingual fentanyl (SLF) for breakthrough pain (BTP) in adult opioid-tolerant cancer patients. Patients received one dose of placebo, SLF 100, 200 and 400 microg in random order at four pain episodes. The primary efficacy endpoint was pain intensity difference (PID) from baseline. Twenty-seven patients received study medication. Overall PID increased significantly with SLF 400 microg versus placebo (8.57 mm, p <0.0001). Improvements were statistically different from placebo at 15 min (p = 0.005). SLF 100 and 200 microg showed a numerical trend towards improved pain relief. A dose that gave a clinically important reduction in pain (PID > 20 mm) was identified by 95% of patients. Reduced use of rescue medication (p < 0.001, SLF 400 microg) and improved global assessment of treatment (p = 0.0146, SLF 400 microg) confirmed these differences as clinically important. Nausea and dizziness were the most common treatment-related adverse effects. SLF appears to be a fast, effective and well-tolerated treatment for BTP.
authors.affiliation: Sahlgrenska Akademin, Göteborg University, Gothenburg, Sweden.
authors.forename: Bo
authors.initials: B
authors.lastname: Lennernäs
authors.forename: Ingela
authors.initials: I
authors.lastname: Frank-Lissbrant
authors.forename: Hans
authors.initials: H
authors.lastname: Lennernäs
authors.forename: Karl Mikael
authors.initials: KM
authors.lastname: Kälkner
authors.forename: Rob
authors.initials: R
authors.lastname: Derrick
authors.forename: Julian
authors.initials: J
authors.lastname: Howell
mesh_terms: D000286:Administration, Sublingual; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D018592:Cross-Over Studies; D004244:Dizziness / Q000139:chemically induced; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009369:Neoplasms / Q000150:complications*; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D010147:Pain Measurement / Q000379:methods; D010919:Placebos; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000701:Analgesics, Opioid; D010919:Placebos; D005283:Fentanyl