Single dose oral rofecoxib for postoperative pain
Abstract
Background
Editor's note: The anti‐inflammatory drug rofecoxib (Vioxx) was withdrawn from the market at the end of September 2004 after it was shown that long‐term use (greater than 18 months) could increase the risk of heart attack and stroke. So far, other similar anti‐inflammatory drugs are unaffected. Further information is available at www.vioxx.com.
Rofecoxib is a selective cyclooxygenase‐2 (COX‐2) inhibitor that was licensed in the UK and the US for acute pain treatment and is associated with fewer gastrointestinal adverse events than conventional NSAIDs. Rofecoxib is believed to be at least as effective as conventional non‐steroidal anti‐inflammatory drugs (NSAIDs) for postoperative pain.
Objectives
To assess the analgesic efficacy and adverse effects of a single oral dose of rofecoxib for moderate to severe postoperative pain, and to compare its effectiveness with other analgesics used for treating acute pain.
Search methods
We searched The Cochrane Library (Issue 1, 2002), MEDLINE (1966 to March 2002), Biological Abstracts (1985 to Dec 2001), CINAHL (1982 to Dec 2001), Psychinfo (1967 to Jan 2002), PubMed (March 2001) and the Oxford pain database.
Selection criteria
Randomised controlled trials (RCTs) of adult patients who received either rofecoxib or placebo for postoperative pain.
Data collection and analysis
Studies were quality scored and the data extracted by two review authors independently. Summed pain relief (TOTPAR) or pain intensity difference (SPID) was extracted and converted into dichotomous information yielding the number of patients with at least 50% pain relief. These derived results were used to calculate the relative benefit (RB) and number‐needed‐to‐treat (NNT) for one patient to achieve at least 50% pain relief.
Main results
Seven studies met the inclusion criteria. All the studies were funded by Merck & Company, the manufacturer of rofecoxib. In total, 667 participants were treated with rofecoxib 50 mg and 315 with placebo. The NNT for rofecoxib 50 mg was 2.2 (95% CI 1.9 to 2.4), i.e., for every two participant treated with rofecoxib 50 mg, one participant experienced at least 50% pain relief that would not have done had they received placebo. All the studies were of short duration, and reported adverse events occurred less frequently with rofecoxib 50 mg than with placebo.
Authors' conclusions
Rofecoxib 50 mg (a dose two to four times the standard daily dose for chronic pain) is an effective single dose oral analgesic for acute postoperative pain.
PICOs
Plain language summary
Single dose oral rofecoxib for postoperative pain
The aim of this review was to assess the analgesic efficacy and adverse effects of a single oral dose of rofecoxib for moderate to severe postoperative pain, and to compare its effectiveness with other analgesics used for treating acute pain. The management of acute postoperative pain is not always straightforward, and can be poorly treated. A variety of analgesic options are available, including conventional non‐steroidal anti‐inflammatory drugs (NSAIDs) such as ibuprofen, naproxen and diclofenac. NSAIDs have pain‐relieving, antipyretic and anti‐inflammatory properties; are proven to be effective following day surgery and minor surgery; and have an opiate‐sparing effect after more major surgery. However, a major concern regarding the use of conventional NSAIDs postoperatively is the possibility of bleeding from both the operative site (because of the inhibition of platelet aggregation) (Forrest 2002) and from the upper gastrointestinal tract, (especially in patients stressed by surgery, the elderly, frail or dehydrated). Drug treatments that combine the pain‐relieving properties of NSAIDs without these adverse effects are likely to have a place in clinical practice. A new generation of NSAIDs has been developed that appear to address the problem of upper gastrointestinal bleeding. These are the 'selective cyclo‐oxygenase‐2 inhibitors' or 'coxibs'. This review found that Rofecoxib 50 mg is an effective single dose oral analgesic in acute postoperative pain but also calls for further research and an improvement in the quality of reporting, particularly with regard to aspects such as the duration of analgesia and adverse effects, would be welcomed.
Editor's note: The anti‐inflammatory drug rofecoxib (Vioxx) was withdrawn from the market at the end of September 2004 after it was shown that long‐term use (greater than 18 months) could increase the risk of heart attack and stroke. So far, other similar anti‐inflammatory drugs are unaffected. Further information is available at www.vioxx.com.
