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

• Published in: Journal of pain and symptom management 2016-07, Vol.52 (1), p.27-34
• Main Authors: Mercadante, Sebastiano, MD, Aielli, Federica, MD, Adile, Claudio, MD, Costanzi, Andrea, MD, Casuccio, Alessandra, BS
• Format: Article
• Language: English
• Subjects: Administration, Oral; Analgesics - administration & dosage; Anesthesia & Perioperative Care; breakthrough pain; Breakthrough Pain - drug therapy; Cancer pain; Cancer Pain - drug therapy; Cross-Over Studies; Female; Fentanyl - administration & dosage; fentanyl pectin nasal spray; Humans; Male; Middle Aged; Morphine - administration & dosage; Nasal Sprays; oral morphine; Pain Measurement; Pain Medicine; Pectins - administration & dosage; Treatment Outcome
• ISSN: 0885-3924; 1873-6513
• DOI: 10.1016/j.jpainsymman.2016.01.010

Abstract Context 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. Objectives 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. Methods 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. Results 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