TRANSDERMAL FENTANYL IN THE MANAGEMENT OF CANCER PAIN IN AMBULATORY PATIENTS - AN OPEN-LABEL PILOT-STUDY

We performed an open-label Pilot study to define analgesic efficacy, a cceptability and toxicity of transdermal fentanyl in an ambulatory pop ulation of patients with cancer pain. Our 7-day study included 35 pati ents, all of whom had failed a trial of an opioid analgesic convention ally used for moderate pain. Patients received either a 25 mu g/hr or 50 mu g/hr fentanyl transdermal patch depending on pier opioid dose. P ain was measured daily utilizing visual analogue (VAS) and categorical (CAT) scales. Hours of nighttime sleep, quality of life, toxicities, and use of rescue medication were also assessed. There was a 24%-29% r eduction in mean VAS and CAT pain scores as compared with the baseline and a 25% increase in mean hours of nighttime sleep. Fifty-nine perce nt of those patients responding (46% of all study patients) were satis fied to very satisfied with the analgesia provided by transdermal fent anyl. Six percent of an study patients were not at all satisfied with the pain relief obtained. Toxicities were similar to those seen with o ther opioids. No patient developed severe sedation or respiratory depr ession. The 25-50 mu g/hr patch appears to be a safe starting dosage i n ambulatory patients previously receiving opioids conventionally used for moderate pain.