Single dose oral fenoprofen for acute postoperative pain in adults Stable (no update expected for reasons given in 'What's new')

Abstract

Abstract Background

Fenoprofen is a non‐steroidal anti‐inflammatory drug (NSAID), available in several different countries, but not widely used.

Objectives

To assess the efficacy of single dose oral fenoprofen in acute postoperative pain, and associated adverse events.

Search methods

We searched Cochrane CENTRAL, MEDLINE, EMBASE and the Oxford Pain Relief Database for studies to December 2010.

Selection criteria

Single oral dose, randomised, double‐blind, placebo‐controlled trials of fenoprofen for relief of established moderate to severe postoperative pain in adults.

Data collection and analysis

Studies were assessed for methodological quality and data extracted by two review authors independently. Summed total pain relief (TOTPAR) or pain intensity difference (SPID) over 4 to 6 hours was used to calculate the number of participants achieving at least 50% pain relief. These derived results were used to calculate, with 95% confidence intervals, the relative benefit compared to placebo, and the number needed to treat (NNT) for one participant to experience at least 50% pain relief over 4 to 6 hours. Numbers of participants using rescue medication over specified time periods, and time to use of rescue medication, were sought as additional measures of efficacy. Information on adverse events and withdrawals was collected.

Main results

Five studies (696 participants) met the inclusion criteria; 24 participants were treated with fenoprofen 12.5 mg, 23 with fenoprofen 25 mg, 79 with fenoprofen 50 mg, 78 with fenoprofen 100 mg, 146 with fenoprofen 200 mg, 55 with fenoprofen 300 mg, 43 with zomepirac 100 mg, 30 with morphine 8 mg, 77 with codeine 60 mg, and 141 with placebo. Participants had pain following third molar extraction, laparoscopy, minor day surgery and episiotomy. The NNT for at least 50% pain relief over 4 to 6 hours with a single dose of fenoprofen 200 mg compared to placebo was 2.3 (1.9 to 3.0). There were insufficient data to analyse other doses or active comparators, time to use of rescue medication, or numbers of participants needing rescue medication. There was no difference in numbers of participants experiencing any adverse events between fenoprofen 200 mg and placebo. No serious adverse events or adverse event withdrawals were reported in these studies.

Authors' conclusions

Oral fenoprofen 200 mg is effective at treating moderate to severe acute postoperative pain, based on limited data for at least 50% pain relief over 4 to 6 hours. Efficacy of other doses, other efficacy outcomes, and safety and tolerability could not be assessed.

Author(s)

Maria X Traa, Sheena Derry, R Andrew Moore

Abstract

Plain language summary

Single dose oral fenoprofen for acute postoperative pain in adults

Fenoprofen is a non‐steroidal anti‐inflammatory drug (NSAID) that is used as a painkiller (analgesic). Five studies looking at a total of 696 participants were included. Because fewer than 200 participants were treated with any one dose of fenoprofen within each study, results must be treated with caution. A good level of pain relief was experienced by better than one in two (over half; 57%) of those with moderate or severe postoperative pain after a single dose of fenoprofen 200 mg, compared to about 1 in 7 (14%) with placebo. This level of pain relief is comparable to that experienced with ibuprofen 400 mg. The frequency of adverse events did not differ between fenoprofen 200 mg and placebo in these studies.

Author(s)

Maria X Traa, Sheena Derry, R Andrew Moore

Reviewer's Conclusions

Authors' conclusions

Implications for practice

Fenoprofen appears to be an effective analgesic for relief of postoperative pain following a variety of procedures, based on this very limited data set. No serious adverse events were reported in any of the studies, though numbers were too small to exclude rare but serious harm.

Implications for research

Given the large number of available drugs of this and similar classes to treat postoperative pain, there is no urgent research agenda, and indeed the most recent studies identified were published in the mid 1980s. More studies could more accurately determine efficacy, but are unlikely to be performed because of well known alternatives. Such studies would need to improve reporting of outcomes other than pain relief and pain intensity difference, such as adverse events and time to remedication.

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