Lennernas, B., Frank-Lissbrant, I., Lennernas, H., Kalkner, K.M., Derrick, R., & Howell, J. (2010). Sublingual administration of fentanyl to cancer patients is an effective treatment for breakthrough pain: Results from a randomized phase II study. Palliative Medicine, 24(3), 286–293.doi: 10.1177/0269216309356138
To evaluate the efficacy and tolerability of sublingual fentanyl for the treatment of breakthrough pain in opioid-tolerant cancer patients
This study was conducted from July 2002 to January 2004 at five university clinics in Sweden. Patients had locally advanced or metastatic cancer and were currently
Each patient received, at four pain episodes occurring between 0700 and 1600 (defined as the treatment period), a placebo dose and 100, 200, and 400 mcg doses of sublingual fentanyl. The doses were provided in a random order, according to a computer-generated randomization list. At least one day fell between each treatment period, to avoid carry-over effects. Patients were asked to rate their pain at the onset of an episode of breakthrough pain and then at 5, 10, 15, 20, and 30 minutes postingestion of the study drug. At 60 minutes, the patients were asked to make a global assessment of the treatment by using a four-point scale.
Randomized, multicenter double-blind, four-period crossover study
Twenty-three patients completed all four treatment doses. Twenty-two of the 23 patients (95%) reported that at least one dose of the sublingual fentanyl produced a clinically important decrease in pain intensity, as measured by a decrease in pain intensity of more than 20 mm on the VAS. In regard to adverse events, 13 patients reported 15 adverse events considered to be related to the study drug. The most common treatment-related adverse effects were nausea and dizziness. Increasing the doses of sublingual fenanyl did not appear to increase the number or severity of adverse events, when evaluated related to increasing doses of sublingual fentanyl.
Within 15 minutes of administration, 400 micrograms of sublingual fentanyl proved more effective than placebo at significantly improving overall pain intensity difference. This was true over the entire treatment period. In regard to reducing pain intensity, results showed that the 100 and 200 mcg doses of sublingual fentanyl were more effective than placebo.
Further study is needed to determine, in regard to decreasing breakthrough pain, the efficacy of each of the doses of sublingual fentanyl.