Sebastiano Mercadante1, Federica Aielli2, Claudio Adile3, Andrea Costanzi4, Alessandra Casuccio5. 1. Anesthesia and Intensive Care Unit and Pain Relief and Palliative Care Unit, La Maddalena Cancer Center, Palermo, Italy. Electronic address: terapiadeldolore@lamaddalenanet.it. 2. Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy. 3. Anesthesia and Intensive Care Unit and Pain Relief and Palliative Care Unit, La Maddalena Cancer Center, Palermo, Italy. 4. Department of Oncology, Hospital Sant'Andrea, University of Rome, Rome, Italy. 5. Department of Experimental Biomedicine and Clinical Neuroscience, University of Palermo, Palermo, Italy.
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 < 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. CONCLUSION: 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.
RCT Entities:
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:Cancerpatients 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 < 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. CONCLUSION: 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: Ahsan Azhar; Yu Jung Kim; Ali Haider; David Hui; Vishidha R Balankari; Margeaux Chiou Epner; Minjeong Park; Diane D Liu; Janet Williams; Susan E Frisbee-Hume; Julio A Allo; Eduardo Bruera Journal: Oncologist Date: 2018-09-25
Authors: Robert Janknegt; Marieke van den Beuken; Sjouke Schiere; Michael Überall; Roger Knaggs; Jaquie Hanley; Morten Thronaes Journal: Eur J Hosp Pharm Date: 2017-01-11