title: Fentanyl Pectin Nasal Spray Versus Oral Morphine in Doses Proportional to the Basal Opioid Regimen for the Management of Breakthrough Cancer Pain: A Comparative Study.
abstract: Fentanyl products have shown superiority over oral opioids for the management of breakthrough cancer pain (BTcP). However, these studies did not use an appropriate patient selection, and drugs have been compared using a different rationale.
  
  
  
  The aim of this randomized, crossover, controlled study was to compare the efficacy and safety of fentanyl pectin nasal spray (FPNS) and oral morphine (OM), given in doses proportional to opioid daily doses.
  
  
  
  Cancer patients with pain receiving ≥60 mg of OM equivalents/day and presenting with ≤3 episodes of BTcP/day were included. Patients received, in a randomized, crossover manner, FPNS or OM at doses proportional to the daily opioid regimen in four consecutive episodes of BTcP. Pain intensity was measured before (T0), 15 (T15), and 30 minutes (T30) after study drugs.
  
  
  
  A total of 167 episodes were treated, 82 with FNPS and 85 with OM. A statistical difference in pain intensity between the two groups was observed at T15, but not at T30 (P = 0.018 and P = 0.204, respectively). In a greater number of episodes treated with FPNS, there was a pain decrease of ≥33% in comparison with OM after 15 and 30 minutes (76.5% vs. 32.8%, and 89% vs. 54.9%, respectively). Similar differences were found in the decrease in pain intensity of ≥50% after 15 and 30 minutes (52.3% vs. 11.4%, and 75% vs. 45.8%, respectively). The difference was highly significant at T15 (P < 0.0005). The mean (SD) pain difference at T15 of FPNS and OM were 3.24 (1.7) and 2.70 (1.2), respectively, whereas the mean (SD) SPIDs30 of FPNS and OM were 4.87 (1.7) and 4.54 (1.5), respectively. The difference was highly significant at T15 (P = 0.019). No severe adverse effects after study drug administration were observed.
  
  
  
  When used in doses proportional to the basal opioid regimen, FPNS showed a superior analgesic effect over OM for the management of BTcP. Only minor adverse effects were found with both medications.
authors.affiliation: Anesthesia and Intensive Care Unit and Pain Relief and Palliative Care Unit, La Maddalena Cancer Center, Palermo, Italy. Electronic address: terapiadeldolore@lamaddalenanet.it.
authors.forename: Sebastiano
authors.initials: S
authors.lastname: Mercadante
authors.affiliation: Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.
authors.forename: Federica
authors.initials: F
authors.lastname: Aielli
authors.affiliation: Anesthesia and Intensive Care Unit and Pain Relief and Palliative Care Unit, La Maddalena Cancer Center, Palermo, Italy.
authors.forename: Claudio
authors.initials: C
authors.lastname: Adile
authors.affiliation: Department of Oncology, Hospital Sant'Andrea, University of Rome, Rome, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Costanzi
authors.affiliation: Department of Experimental Biomedicine and Clinical Neuroscience, University of Palermo, Palermo, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Casuccio
mesh_terms: D000284:Administration, Oral; D000700:Analgesics / Q000008:administration & dosage*; D059390:Breakthrough Pain / Q000188:drug therapy*; D000072716:Cancer Pain / Q000188:drug therapy*; D018592:Cross-Over Studies; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009020:Morphine / Q000008:administration & dosage*; D059085:Nasal Sprays; D010147:Pain Measurement; D010368:Pectins / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D000700:Analgesics; D059085:Nasal Sprays; D009020:Morphine; D010368:Pectins; D005283:Fentanyl
keywords: Cancer pain; breakthrough pain; fentanyl pectin nasal spray; oral morphine