title: Fentanyl Buccal Tablet vs. Oral Morphine in Doses Proportional to the Basal Opioid Regimen for the Management of Breakthrough Cancer Pain: A Randomized, Crossover, Comparison Study.
abstract: BACKGROUND
  Fentanyl products have shown superiority to oral opioids for the management of breakthrough cancer pain (BTcP). However, these studies did not use appropriate patient selection, and drugs have been compared by using different rationales.
  
  
  OBJECTIVE
  The aim of this randomized, crossover, controlled study was to compare efficacy and safety of fentanyl buccal tablets (FBTs) and oral morphine (OM), given in doses proportional to opioid daily doses.
  
  
  METHODS
  Cancer patients with pain receiving ≥60 mg or more of oral morphine equivalents per day and presenting with ≤3 episodes of BTcP per day were included. In a randomized, crossover manner, patients received FBT or OM at doses proportional to the daily opioid regimen in four consecutive episodes of BTcP. Pain intensity was measured before (T0) and 15 (T15) and 30 minutes (T30), after study drugs.
  
  
  RESULTS
  In total, 263 episodes of BTcP were treated. A statistical difference in changes in pain intensity-decrease of ≥33% and ≥50%-between the two groups was observed at T15 and T30 (P < 0.0005). No severe adverse effects after study drug administration were observed.
  
  
  CONCLUSIONS
  When used in doses proportional to the basal opioid regimen, FBT showed a clear superiority and was well tolerated when compared with OM during the first 30 minutes, which is the approximate target for a timely intervention required for a BTcP medication.
authors: Anesthesia and Intensive Care Unit and Pain Relief and Palliative Care Unit, La Maddalena Cancer Center, Palermo, Italy. Electronic address: terapiadeldolore@lamaddalenanet.it.
authors: Sebastiano
authors: S
authors: Mercadante
authors: Anesthesia and Intensive Care Unit and Pain Relief and Palliative Care Unit, La Maddalena Cancer Center, Palermo, Italy.
authors: Claudio
authors: C
authors: Adile
authors: Anesthesia and Pain Therapy, National Cancer Institute Pascale, Naples, Italy.
authors: Arturo
authors: A
authors: Cuomo
authors: Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.
authors: Federica
authors: F
authors: Aielli
authors: Section of Anesthesia, Analgesia, Intensive Care and Emergency, Department of Biopathology, Medical and Forensic Biotechnologies, Policlinico P. Giaccone, University of Palermo, Palermo, Italy.
authors: Andrea
authors: A
authors: Cortegiani
authors: Department of Experimental Biomedicine and Clinical Neuroscience, University of Palermo, Palermo, Italy.
authors: Alessandra
authors: A
authors: Casuccio
authors: Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.
authors: Giampiero
authors: G
authors: Porzio
mesh_terms: D000278:Administration, Buccal; D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000009:adverse effects; D059390:Breakthrough Pain / Q000188:drug therapy* / Q000503:physiopathology; D018592:Cross-Over Studies; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009020:Morphine / Q000008:administration & dosage* / Q000009:adverse effects; D009369:Neoplasms / Q000188:drug therapy / Q000503:physiopathology; D010147:Pain Measurement; D057240:Patient Preference; D016896:Treatment Outcome
chemical_list: D000701:Analgesics, Opioid; D009020:Morphine; D005283:Fentanyl
keywords: Cancer pain; breakthrough pain; fentanyl buccal tablet; oral morphine