Journal Article

Randomised crossover trial of transdermal fentanyl and sustained release oral morphine for treating chronic non-cancer pain

Donald, Royden, Allan, Laurie, Kalso, Eija, Hays, Helen, Jensen, Niels-Henrik, Bolt, Michiel, de Waroux, Bernard Le Polain

2001

Overview

Abstract Objectives: To compare patients' preference for transdermal fentanyl or sustained release oral morphine, their level of pain control, and their quality of life after treatment. Design: Randomised, multicentre, international, open label, crossover trial. Setting: 35 centres in Belgium, Canada, Denmark, Finland, the United Kingdom, the Netherlands, and South Africa. Participants: 256 patients (aged 26-82 years) with chronic non-cancer pain who had been treated with opioids. Main outcome measures: Patients' preference for transdermal fentanyl or sustained release oral morphine, pain control, quality of life, and safety assessments. Results: Of 212 patients, 138 (65%) preferred transdermal fentanyl, whereas 59 (28%) preferred sustained release oral morphine and 15 (7%) expressed no preference. Better pain relief was the main reason for preference for fentanyl given by 35% of patients. More patients considered pain control as being “good” or “very good” with fentanyl than with morphine (35% v 23%, P=0.002). These results were reflected in both patients' and investigators' opinions on the global efficacy of transdermal fentanyl. Patients receiving fentanyl had on average higher quality of life scores than those receiving morphine. The incidence of adverse events was similar in both treatment groups; however, more patients experienced constipation with morphine than with fentanyl (48% v 29%, P<0.001). Overall, 41% of patients experienced mild or moderate cutaneous problems associated with wearing the transdermal fentanyl patch, and more patients withdrew because of adverse events during treatment with fentanyl than with morphine (10% v 5%). However, within the subgroup of patients naive to both fentanyl and morphine, similar numbers of patients withdrew owing to adverse effects (11% v 10%, respectively). Conclusion: Transdermal fentanyl was preferred to sustained release oral morphine by patients with chronic non-cancer pain previously treated with opioids. The main reason for preference was better pain relief, achieved with less constipation and an enhanced quality of life. What is already known on this topic The clinical use of potent opioids in the treatment of chronic non-cancer pain is supported by retrospective, survey data and small randomised controlled trials showing efficacy and safety Studies with transdermal fentanyl have shown efficacy and preference over sustained release oral morphine in the treatment of cancer pain What this study adds This is the first study to provide comparative data supporting treatment options with potent opioids for chronic non-cancer pain Both transdermal fentanyl and sustained release oral morphine provided effective and well tolerated pain relief During fentanyl treatment patients experienced superior pain relief, higher quality of life, and less constipation; fentanyl was preferred to morphine by 65% of patients

• Publisher: British Medical Journal Publishing Group,British Medical Association,BMJ Publishing Group Ltd,BMJ Publishing Group LTD,BMJ
• Subject: Administration, Cutaneous / Adult / Aged / Aged, 80 and over / Analgesics / Analgesics, Opioid - administration & dosage / Analgesics, Opioid - therapeutic use / Cancer / Chronic Disease / Constipation / Controlled release / Cross over studies / Delayed-Action Preparations / Disease / Dosage / Dosage and administration / Drug therapy / Evaluation / Family medical history / Female / Fentanyl / Fentanyl - administration & dosage / Fentanyl - therapeutic use / Humans / Male / Middle Aged / Morphine / Morphine - administration & dosage / Morphine - therapeutic use / Narcotics / Nervous system / Opioid analgesics / Pain / Pain - drug therapy / Pain management / Patient Satisfaction / Pragmatism / Preferences / Primary Care / Quality of life / Transdermal application / Transdermal drug delivery systems / Transdermal medication