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

Abstract

Abstract Background

Tenoxicam is a non‐steroidal anti‐inflammatory drug (NSAID) licensed for use in rheumatic disease and other musculoskeletal disorders in the UK, and is widely available in other countries worldwide. This review sought to evaluate the efficacy and safety of oral tenoxicam in acute postoperative pain, using clinical studies of patients with established pain, and with outcomes measured primarily over 6 hours using standard methods. This type of study has been used for many decades to establish that drugs have analgesic properties.

Objectives

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

Search methods

We searched The Cochrane Library (Issue 1, 2009), MEDLINE (March 2009); EMBASE via Ovid (March 2009); the Oxford Pain Relief Database.

Selection criteria

Randomised, double‐blind, placebo‐controlled clinical trials of oral tenoxicam for relief of acute postoperative pain in adults.

Data collection and analysis

Two review authors independently assessed trial quality and extracted data. The area under the "pain relief versus time" curve was used to derive the proportion of participants with tenoxicam experiencing least 50% pain relief over 4 to 6 hours, using validated equations. The number needed to treat to benefit (NNT) was calculated using 95% confidence intervals (CI). The proportion of participants using rescue analgesia over a specified time period, and time to use of rescue analgesia, were sought as additional measures of efficacy. Information on adverse events and withdrawals was also collected.

Main results

Not one of sixteen studies identified by the searches and examined in detail studied oral tenoxicam in patients with established postoperative pain and therefore no results are available.

Authors' conclusions

In the absence of evidence of efficacy for oral tenoxicam in acute postoperative pain, its use in this indication is not justified at present. Because trials clearly demonstrating analgesic efficacy in the most basic of acute pain studies is lacking, use in other indications should be evaluated carefully. Given the large number of available drugs of this and similar classes which are effective, there is no urgent research agenda for this particular drug.

Author(s)

Owen A Moore, Mairead McIntyre, R Andrew Moore, Sheena Derry, Henry J McQuay

Abstract

Plain language summary

Single dose oral tenoxicam for acute postoperative pain in adults

Pain is commonly experienced after surgical procedures. Acute postoperative pain of moderate or severe intensity is often used (as a model) to test whether or not drugs are effective painkillers. In this case we could find no studies that tested oral tenoxicam against placebo. It is possible that the studies were done, but not reported, because they were used only to register tenoxicam with licensing authorities throughout the world. However, this leaves an important gap in our knowledge, and it means that we cannot be confident about using oral tenoxicam for acute painful conditions.

Author(s)

Owen A Moore, Mairead McIntyre, R Andrew Moore, Sheena Derry, Henry J McQuay

Reviewer's Conclusions

Authors' conclusions

Implications for practice

In the absence of evidence of efficacy for oral tenoxicam in acute postoperative pain, its use in this indication is not justified. Because trials clearly demonstrating analgesic efficacy in the most basic of acute pain studies is lacking, use in other indications should be evaluated carefully.

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.

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