ORAL TRANSMUCOSAL FENTANYL CITRATE - RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED TRIAL FOR TREATMENT OF BREAKTHROUGH PAIN IN CANCER-PATIENTS

Background: Patients with cancer frequently experience episodes of acu te pain, i.e., breakthrough pain, superimposed on their chronic pain. Breakthrough pain is usually treated with short-acting oral opioids, m ost of which provide some relief after 15-20 minutes, with peak effect s after 30-45 minutes. Oral transmucosal fentanyl citrate (OTFC), a un ique formulation of the opioid fentanyl, has been shown to provide mea ningful pain relief within 5 minutes in patients following surgery. We conducted a multicenter, randomized, double-blinded, placebo-controll ed trial of OTFC for cancer-related breakthrough pain. Methods: Patien ts who were 18 years of age or older, receiving the equivalent of at l east 60 mg oral morphine or at least 50 mu g transdermal fentanyl per day for chronic cancer-related pain, and experiencing at least one epi sode of breakthrough pain per day were studied. After titration to an effective OTFC dose, subjects were given 10 randomly ordered treatment units (seven OTFC units and three placebo units) in the form of ident ical lozenges. If acceptable pain relief was not achieved within 30 mi nutes, subjects were instructed to take their previous breakthrough pa in medication (i.e., rescue medication). Pain intensity, pain relief, and use of rescue medication were evaluated at 15-minute intervals ove r a 60-minute period. Results: Eighty-nine of 92 patients who received the randomized treatment were assessable (i.e., treated with at least one unit of OTFC and one unit of placebo). OTFC produced significantl y larger changes in pain intensity and better pain relief than placebo at all time points (two-sided P<.0001), Episodes treated with placebo required the use of rescue medication more often than episodes treate d with OTFC (34% versus 15%; relative risk = 2.27; 95% confidence inte rval = 1.51-3.26; two-sided P<.0001), Conclusions: OTFC appears effect ive in the treatment of cancer-related breakthrough pain.