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. 2016 Oct 11;10(10):CD011605.
doi: 10.1002/14651858.CD011605.pub2.

Fentanyl for neuropathic pain in adults

Sheena Derry  1 , Cathy Stannard, Peter Cole, Philip J Wiffen, Roger Knaggs, Dominic Aldington, R Andrew Moore
Affiliations

Fentanyl for neuropathic pain in adults

Sheena Derry et al. Cochrane Database Syst Rev. .

Abstract

Background: Opioid drugs, including fentanyl, are commonly used to treat neuropathic pain, and are considered effective by some professionals. Most reviews have examined all opioids together. This review sought evidence specifically for fentanyl, at any dose, and by any route of administration. Other opioids are considered in separate reviews.

Objectives: To assess the analgesic efficacy of fentanyl for chronic neuropathic pain in adults, and the adverse events associated with its use in clinical trials.

Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase from inception to June 2016, together with the reference lists of retrieved articles, and two online study registries.

Selection criteria: We included randomised, double-blind studies of two weeks' duration or longer, comparing fentanyl (in any dose, administered by any route, and in any formulation) with placebo or another active treatment in chronic neuropathic pain.

Data collection and analysis: Two review authors independently searched for studies, extracted efficacy and adverse event data, and examined issues of study quality and potential bias. We did not carry out any pooled analyses. We assessed the quality of the evidence using GRADE.

Main results: Only one study met our inclusion criteria. Participants were men and women (mean age 67 years), with postherpetic neuralgia, complex regional pain syndrome, or chronic postoperative pain. They were experiencing inadequate relief from non-opioid analgesics, and had not previously taken opioids for their neuropathic pain. The study used an enriched enrolment randomised withdrawal design. It was adequately blinded, but we judged it at unclear risk of bias for other criteria.Transdermal fentanyl (one-day fentanyl patch) was titrated over 10 to 29 days to establish the maximum tolerated and effective dose (12.5 to 50 µg/h). Participants who achieved a prespecified good level of pain relief with a stable dose of fentanyl, without excessive use of rescue medication or intolerable adverse events ('responders'), were randomised to continue with fentanyl or switch to placebo for 12 weeks, under double-blind conditions. Our prespecified primary outcomes were not appropriate for this study design, but the measures reported do give an indication of the efficacy of fentanyl in this condition.In the titration phase, 1 in 3 participants withdrew because of adverse events or inadequate pain relief, and almost 90% experienced adverse events. Of 258 participants who underwent open-label titration, 163 were 'responders' and entered the randomised withdrawal phase. The number of participants completing the study (and therefore continuing on treatment) without an increase of pain by more than 15/100 was 47/84 (56%) with fentanyl and 28/79 (35%) with placebo. Because only 63% responded sufficiently to enter the randomised withdrawal phase, this implies that only a maximum of 35% of participants entering the study would have had useful pain relief and tolerability with transdermal fentanyl, compared with 22% with placebo. Almost 60% of participants taking fentanyl were 'satisfied' and 'very satisfied' with their treatment at the end of the study, compared with about 40% with placebo. This outcome approximates to our primary outcome of moderate benefit using the Patient Global Impression of Change scale, but the group was enriched for responders and the method of analysis was not clear. The most common adverse events were constipation, nausea, somnolence, and dizziness.There was no information about other types of neuropathic pain, other routes of administration, or comparisons with other treatments.We downgraded the quality of the evidence to very low because there was only one study, with few participants and events, and there was no information about how data from people who withdrew were analysed.

Authors' conclusions: There is insufficient evidence to support or refute the suggestion that fentanyl works in any neuropathic pain condition.

PubMed Disclaimer

Conflict of interest statement

SD: none known.

CS: none known. She is a specialist pain physician and manages patients with chronic pain.

PC received support from Boston Scientific (2014) for travel and accommodation at a scientific meeting; Boston Scientific does not market drugs. PC is a specialist pain physician and manages patients with chronic pain.

PW: none known.

RK has consulted for Grunenthal Ltd (2014‐15) and MundiPharma Research (2015), and received lecture fees from Grunenthal Ltd (2013‐14) and Pfizer Ltd (2013‐14). He is an Associate Professor in Clinical Pharmacy Practice and Advanced Pharmacy Practitioner.

DA has received lecture fees from Grünenthal (2013, 2014, 2015) and Pfizer (2013, 2016). He is a specialist pain physician and manages patients with chronic pain.

RAM has received grant support from RB relating to individual patient‐level analyses of trial data on ibuprofen in acute pain and the effects of food on drug absorption of analgesics (2013), and from Grünenthal relating to individual patient‐level analyses of trial data regarding tapentadol in osteoarthritis and back pain (2015). He has received honoraria for attending boards with Menarini concerning methods of analgesic trial design (2014), with Novartis about the design of network meta‐analyses (2014), and RB on understanding the pharmacokinetics of drug uptake (2015).

Figures

1
1
Study flow diagram.
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
See this image and copyright information in PMC

Update of

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