Transdermal fentanyl for cancer pain: Trial sequential analysis of 3406 patients from 35 randomized controlled trials

J Cancer Res Ther. 2018;14(Supplement):S14-S21. doi: 10.4103/0973-1482.171368.


Objective: The aim of this study was to assess the effectiveness and safety of transdermal fentanyl for the treatment of moderate or severe cancer-related pain.

Materials and methods: Electronic databases including PubMed, Embase, the Cochrane Library, Web of Science, Chinese National Knowledge Infrastructure, the Chinese Biomedical Literature Database, and Chongqing Weipu and Wanfang Database were searched for relevant studies published prior to January 2015. Only randomized controlled trials on the use of the transdermal fentanyl patch for the treatment of cancer pain were selected. Two reviewers independently screened the studies and extracted data. The quality assessment of the studies included was based on the Cochrane Handbook for Systematic Reviews of Interventions (version 5.1.0). RevMan 5 (version 5.3) and Trial Sequential Analysis software (TSA, version 2.1, provided by Copenhagen Trial Unit, Denmark) were used for data analyses.

Results: A total of 35 studies involving 3406 participants met the inclusion criteria for this meta-analysis. There was no statistically significant difference with regard to the effectiveness of management for cancer pain between the use of transdermal fentanyl patch and oral morphine (risk ratio = 1.00, 95% confidence interval, 0.97-1.03, P > 0.05). TSA results demonstrated that the cumulative Z-score crossed its monitoring boundaries, and therefore, reliable conclusions had been drawn. Moreover compared with oral morphine, the use of transdermal fentanyl patch resulted in statistically significantly decreased incidence of constipation, nausea and vomiting, drowsiness, and urinary retention. There was a significantly greater incidence of skin irritation in patients who used a transdermal fentanyl patch (P < 0.05).

Conclusions: The findings from this study demonstrate that use of transdermal fentanyl for the management of moderate or severe cancer pain had more advantages compared to oral morphine.

Keywords: Cancer pain; meta-analysis; oral morphine; systematic review; transdermal fentanyl; trial sequential analysis.

Publication types

  • Meta-Analysis
  • Review
  • Systematic Review

MeSH terms

  • Administration, Cutaneous
  • Analgesics, Opioid / administration & dosage*
  • Cancer Pain / drug therapy*
  • Fentanyl / administration & dosage*
  • Humans
  • Neoplasms / complications
  • Odds Ratio
  • Pain Measurement
  • Randomized Controlled Trials as Topic
  • Treatment Outcome


  • Analgesics, Opioid
  • Fentanyl