• Sebastiano Mercadante, Claudio Adile, Arturo Cuomo, Federica Aielli, Andrea Cortegiani, Alessandra Casuccio, and Giampiero Porzio.
• Anesthesia and Intensive Care Unit and Pain Relief and Palliative Care Unit, La Maddalena Cancer Center, Palermo, Italy. Electronic address: terapiadeldolore@lamaddalenanet.it.
• J Pain Symptom Manage. 2015 Nov 1; 50 (5): 579-86.

ContextFentanyl 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.ObjectivesThe 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.MethodsCancer 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.ResultsIn 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.ConclusionWhen 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.Copyright © 2015 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

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