Sublingual fentanyl tablets were not noninferior to subcutaneous morphine for the treatment of severe pain episodes in patients with cancer, according to a study published in the Journal of Clinical Oncology.1
Although sublingual fentanyl is a potentially useful alternative option to parenteral opioids such as subcutaneous morphine to treat severe breakthrough cancer pain, no study has directly compared the 2 approaches.
To assess the noninferiority of sublingual fentanyl vs subcutaneous morphine during the first 30 minutes after administration, investigators enrolled 114 patients receiving stable opioid therapy who were experiencing a severe episode of breakthrough pain in a double-blind, double-dummy trial. Participants were randomly assigned to receive either 100 μg of sublingual fentanyl or 5 mg of subcutaneous morphine.
Baseline pain intensities were 7.5 in both arms. Investigators evaluated pain intensity using a 0 to 10 numerical scale at 10, 20, and 30 minutes postadministration.
Results showed mean average pain intensities assessed at 10, 20, and 30 minutes after opioid administration were 5.0 and 4.5 with sublingual fentanyl and subcutaneous morphine, respectively. The between-group difference in pain intensity was −0.49 (95% CI, −1.10 to 0.09), which did not meet the predefined noninferiority margin of −0.6.
Researchers also found that patients receiving fentanyl required a second drug dose after 30 minutes more frequently than did those given morphine (57% vs 37%).
Of note, 93% of patients preferred the sublingual route of administration.
1. Zecca E, Brunelli C, Centurioni F, Manzoni A, Pigni A, Caraceni A, et al. Fentanyl sublingual tablets versus subcutaneous morphine for the management of severe cancer pain episodes in patients receiving opioid treatment: a double-blind, randomized, noninferiority trial. J Clin Oncol. 2017 Jan 23. doi: 10.1200/JCO.2016.69.9504. [Epub ahead of print]