Kress, H.G., Von der Laage, D., Hoerauf, K.H., Nolte, T., Heiskanen, T., Petersen, R., . . . Jensen, N.H. (2008). A randomized, open, parallel group, multicenter trial to investigate analgesic efficacy and safety of a new transdermal fentanyl patch compared to standard opioid treatment in cancer pain. Journal of Pain and Symptom Management, 36(3), 268–279.

To compare, in clinical practice, the effect and safety of a new matrix fentanyl patch (Fentanyl Improved Transdermal [FIT]) patch) to oral and other transdermal opioid treatment

Patients were randomly assigned to either FIT patch or standard opioid treatment via oral or transdermal route. Morphine was the only rescue medication allowed. Patients could receive radiotherapy and chemotherapy as well as nonpharmacologic and pharmacologic pain management therapies. Patients randomized to FIT therapy switched from existing regimens to FIT therapy by means of standard conversion ratios. Patients had an initial screening visit and four additional visits. Each evening each patient assessed his or her pain and recorded the pain rating in a diary. Adverse events were monitored in follow-up visits through the 30-day trial period and for one week longer. Patients assessed adverse events on a four-point scale and recorded the rating.

• The sample of patients who completed the trial was composed of 170 patients.
• In the FIT group, mean patient age was 63.1 years (SD = 11.04 years). In the control arm, mean patient age was 61.3 years (SD = 11.66 years).
• Of all patients, 40% were female and 60% were male.
• Overall, 11% of patients randomized were opioid naive.
• Authors did not report cancer diagnoses. All patients had a baseline Karnofsky performance score of 50 or higher.

• Multisite
• Outpatient
• Seven European countries

Randomized open-label parallel-group design

• Numeric rating scale (0–10), to measure pain intensity
• Four-point scale to rate adverse events, including constipation, nausea, sleep disturbance, and daytime drowsiness

• There was no significant difference between groups regarding pain intensity ratings.
• Subgroup analysis revealed no differences based on concomitant chemotherapy or radiotherapy or on subgroup analysis based on nocioceptive versus neuropathic pain.
• Between groups, there were no significant differences in the prevalence or severity of adverse effects.
• Authors observed no new or unexpected adverse drug reactions.

Results showed no differences, in terms of pain management or adverse effects, between the new transdermal patch and standard transdermal or oral opioid treatment. Findings suggest that the new type of patch is safe and, in terms of efficacy, similar to standard treatments.

• The study has a risk of bias due to no appropriate control group.
• Authors provided no analysis of other medications or approaches used for pain management. (These were not controlled in the study.) Authors did not report analysis of morphine use for breakthrough pain.
• Patients' diaries were the source of adverse events and pain intensity scores. Note, however, that authors stated that patients' records regarding rescue medication, for example, could not have been accurate. If patients' records were inaccurate, the study should have provided objective or observer scoring.

Transdermal fentanyl, delivered by means of conventional patch or FIT patch, is an effective means of controlling cancer pain.