Single dose oral paracetamol (acetaminophen) for postoperative pain

Abstract

Background: Paracetamol (acetaminophen) and non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for the relief of mild and moderate pain arising from headache, musculoskeletal conditions and dysmenorrhoea. A prior Cochrane systematic review concluded that paracetamol is also effective for postoperative pain, but additional trials have since been published. This review sought to evaluate the efficacy and safety of paracetamol using current data, and to compare the findings with other analgesics evaluated in the same way.

Objectives: To assess the efficacy of single dose oral paracetamol for the treatment of acute postoperative pain.

Search strategy: We searched the Cochrane Library (Issue 3, 2002), the trials register of the Cochrane Pain, Palliative and Supportive Care group (November 2002); MEDLINE (1966 to May 1996); PubMed (1996 to August 2001); EMBASE (1980 to 1996); the Oxford Pain Relief Database (1950 to 1994); and reference lists of articles in order to update an existing version of the review.

Selection criteria: Randomised, double-blind, placebo-controlled clinical trials of paracetamol for acute postoperative pain in adults.

Data collection and analysis: Two reviewers independently assessed trial quality and extracted data. The area under the 'pain relief versus time' curve was used to derive the proportion of patients with paracetamol or placebo experiencing least 50% pain relief over four to six hours using validated equations. The number-needed-to-treat (NNT) was calculated using 95% confidence intervals. Information on adverse effects was also collected.

Main results: Forty-seven reports that enrolled 4186 patients (2561 patients were treated with a single oral dose of paracetamol and 1625 with placebo) met the inclusion criteria and were included in the analyses. The NNTs for at least 50% pain relief over four to six hours following a single dose of paracetamol were as follows: 325 mg NNT 3.8 (2.2 to 13.3); 500 mg NNT 3.5 (2.7 to 4.8); 600/650 mg NNT 4.6 (3.9 to 5.5); 975/1000 mg NNT 3.8 (3.4 to 4.4); and 1500 mg NNT 3.7 (2.3 to 9.5). Sub-group analysis showed no significant differences between smaller and larger trials, or lower and higher quality trials. Drug-related study withdrawals were rarely reported. Studies reported a variable incidence of adverse effects that were generally mild and transient. There were no statistically significant differences in the frequency of reported adverse effects between paracetamol 975/1000 mg and placebo.

Reviewer's conclusions: Single doses of paracetamol are effective analgesics for acute postoperative pain and give rise to few adverse effects.