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

BMJ 2001; 322 doi: https://doi.org/10.1136/bmj.322.7295.1154 (Published 12 May 2001) Cite this as: BMJ 2001;322:1154
  1. Laurie Allan (northwick.pain{at}bigfoot.com), directora,
  2. Helen Hays, associate clinical professorb,
  3. Niels-Henrik Jensen, head of departmentc,
  4. Bernard Le Polain de Waroux, staff anaesthesiologistd,
  5. Michiel Bolt, anaesthesiologiste,
  6. Royden Donald, specialist anaesthetistf,
  7. Eija Kalso, headg
  1. a Chronic Pain Services, Northwick Park and St Mark's NHS Trust, Harrow, Middlesex HA1 3UJ,
  2. b Department of Family Medicine, University of Alberta, Edmonton, Alberta, Canada T6G 2C8,
  3. c Multidisciplinary Pain Centre, Department of Anaesthesiology, Herlev University Hospital, DK-2730, Denmark,
  4. d Cliniques Universitaires St-Luc, 1200 Brussels, Belgium,
  5. e Alg Ziekenhuis Eemland De Lichtenberg, 3818 ES Amersfoort, Netherlands,
  6. f Strand Private Hospital, Cape Town 7139, South Africa,
  7. g Helsinki University Central Hospital Pain Clinic, 00290 Helsinki, Finland
  1. Correspondence to: L Allan
  • Accepted 13 December 2000

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

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

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

Footnotes

  • Funding The study was supported by a grant from Janssen Research Foundation, Belgium.

  • Competing interests LA receives support from both Janssen-Cilag, the manufacturer of transdermal fentanyl (Durogesic) and Napp Laboratories, the manufacturer of sustained release morphine. EK has been reimbursed by Janssen-Cilag for participation at a meeting sponsored by Janssen-Cilag.

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