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Meta-Analysis
. 2009 Jul 8;2009(3):CD002763.
doi: 10.1002/14651858.CD002763.pub2.

Single dose oral oxycodone and oxycodone plus paracetamol (acetaminophen) for acute postoperative pain in adults

Helen Gaskell  1 , Sheena Derry, R Andrew Moore, Henry J McQuay
Affiliations
Meta-Analysis

Single dose oral oxycodone and oxycodone plus paracetamol (acetaminophen) for acute postoperative pain in adults

Helen Gaskell et al. Cochrane Database Syst Rev. .

Abstract

Background: Oxycodone is a strong opioid agonist used to treat severe pain. It is commonly combined with milder analgesics such as paracetamol. This review updates a previous review that concluded, based on limited data, that all doses of oxycodone exceeding 5 mg, with or without paracetamol, provided analgesia in postoperative pain, but with increased incidence of adverse events compared with placebo. Additional new studies provide more reliable estimates of efficacy and harm.

Objectives: To assess efficacy, duration of action, and associated adverse events of single dose oral oxycodone, with or without paracetamol, in acute postoperative pain in adults.

Search strategy: Cochrane CENTRAL, MEDLINE, EMBASE and Oxford Pain Relief Database, searched in May 2009.

Selection criteria: Randomised, double blind, placebo-controlled trials of single dose orally administered oxycodone, with or without paracetamol, in adults with moderate to severe acute postoperative pain.

Data collection and analysis: Two review authors independently assessed trial quality and extracted data. Pain relief or pain intensity data were extracted and converted into the dichotomous outcome of number of participants with at least 50% pain relief over 4 to 6 hours, from which relative risk and number-needed-to-treat-to-benefit (NNT) were calculated. Numbers of participants remedicating over specified time periods, and time-to-use of rescue medication, were sought as additional measures of efficacy. Adverse events and withdrawals information was collected.

Main results: This updated review includes 20 studies, with 2641 participants. For oxycodone 15 mg alone compared with placebo, the NNT for at least 50% pain relief was 4.6 (95% Confidence Interval 2.9 to 11). For oxycodone 10 mg plus paracetamol 650 mg, the NNT was 2.7 (2.4 to 3.1). A dose response was demonstrated for this outcome with combination therapy. Duration of effect was 10 hours with oxycodone 10 mg plus paracetamol 650 mg, and 4 hours with half that dose. Fewer participants needed rescue medication over 6 hours at the higher dose. Adverse events occurred more frequently with combination therapy than placebo, but were generally described as mild to moderate in severity and rarely led to withdrawal.

Authors' conclusions: Single dose oxycodone is an effective analgesic in acute postoperative pain at doses over 5 mg; oxycodone is two to three times stronger than codeine. Efficacy increases when combined with paracetamol. Oxycodone 10 mg plus paracetamol 650 mg provides good analgesia to half of those treated, comparable to commonly used non-steroidal anti-inflammatory drugs, with the benefit of longer duration of action.

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Conflict of interest statement

RAM and HJM have undertaken research/consultants for various pharmaceutical companies. RAM and HJM have received lecture fees from pharmaceutical companies for presentations on analgesics research and other healthcare interventions. RAM, HJM, HG and SD have received research support from charities, government and industry sources at various times. Support for this review came from Oxford Pain Research, the NHS Cochrane Collaboration Programme Grant Scheme, and NIHR Biomedical Research Centre Programme.

JR received lecture fees from pharmaceutical companies for presentations on analgesics research and other healthcare interventions, and received research support from charities, government and industry sources at various times.

Figures

1
1
Forest plot of comparison: 4 Oxycodone 5 mg plus paracetamol 325 mg, outcome: 4.1 Participants with at least 50% pain relief over 4 to 6 hours.
2
2
Forest plot of comparison: 2 Oxycodone 10 mg plus paracetamol 650 mg, outcome: 2.1 Participants with at least 50% pain relief over 4‐6 hours.
3
3
Forest plot of comparison: 6 Oxycodone 10 mg plus paracetamol 1000 mg, outcome: 6.1 Participants with at least 50% pain relief over 4 to 6 hours.
4
4
Forest plot of comparison: 2 Oxycodone 10 mg plus paracetamol 650 mg, outcome: 2.3 Participants using rescue medication within 6 hours.
5
5
Forest plot of comparison: 2 Oxycodone 10 mg plus paracetamol 650 mg, outcome: 2.2 Participants with at least one adverse event.
1.1
1.1. Analysis
Comparison 1 Oxycodone 5 mg v placebo, Outcome 1 Participants with at least 50% pain relief over 4 to 6 hours.
1.2
1.2. Analysis
Comparison 1 Oxycodone 5 mg v placebo, Outcome 2 Participants using rescue medication within 6 hours.
1.3
1.3. Analysis
Comparison 1 Oxycodone 5 mg v placebo, Outcome 3 Participants with at least one adverse event.
2.1
2.1. Analysis
Comparison 2 Oxycodone 15 mg versus placebo, Outcome 1 Participants with at least 50% pain relief over 4 to 6 hours.
3.1
3.1. Analysis
Comparison 3 Oxycodone CR versus placebo, Outcome 1 Participants with at least 50% pain relief over 4 to 6 hours.
4.1
4.1. Analysis
Comparison 4 Oxycodone 5 mg plus paracetamol 325 mg, Outcome 1 Participants with at least 50% pain relief over 4 to 6 hours.
4.2
4.2. Analysis
Comparison 4 Oxycodone 5 mg plus paracetamol 325 mg, Outcome 2 Participants using rescue medication within 6 hours.
4.3
4.3. Analysis
Comparison 4 Oxycodone 5 mg plus paracetamol 325 mg, Outcome 3 Participants with at least one adverse event.
5.1
5.1. Analysis
Comparison 5 Oxycodone 10 mg plus paracetamol 650 mg, Outcome 1 Participants with at least 50% pain relief over 4‐6 hours.
5.2
5.2. Analysis
Comparison 5 Oxycodone 10 mg plus paracetamol 650 mg, Outcome 2 Participants using rescue medication within 6 hours.
5.3
5.3. Analysis
Comparison 5 Oxycodone 10 mg plus paracetamol 650 mg, Outcome 3 Participants using rescue medication within 8 hours.
5.4
5.4. Analysis
Comparison 5 Oxycodone 10 mg plus paracetamol 650 mg, Outcome 4 Participants with at least one adverse event.
6.1
6.1. Analysis
Comparison 6 Oxycodone 10 mg plus paracetamol 1000 mg, Outcome 1 Participants with at least 50% pain relief over 4 to 6 hours.
6.2
6.2. Analysis
Comparison 6 Oxycodone 10 mg plus paracetamol 1000 mg, Outcome 2 Participants using rescue medication within 24 hours.
6.3
6.3. Analysis
Comparison 6 Oxycodone 10 mg plus paracetamol 1000 mg, Outcome 3 Participants with at least one adverse event.
See this image and copyright information in PMC

Update of

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MeSH terms