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      Single dose oral ibuprofen plus paracetamol (acetaminophen) for acute postoperative pain

      systematic-review

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          Abstract

          Background

          Combining two different analgesics in fixed doses in a single tablet can provide better pain relief than either drug alone in acute pain. This appears to be broadly true across a range of different drug combinations, in postoperative pain and migraine headache. Some combinations of ibuprofen and paracetamol are available for use without prescription in some acute pain situations.

          Objectives

          To assess the efficacy and adverse effects of single dose oral ibuprofen plus paracetamol for acute postoperative pain using methods that permit comparison with other analgesics evaluated in standardised trials using almost identical methods and outcomes.

          Search methods

          We searched the Cochrane Central Register of Controlled Trials (CENTRAL) on The Cochrane Library (Issue 4 of 12, 2013), MEDLINE (1950 to May 21st 2013), EMBASE (1974 to May 21st 2013), the Oxford Pain Database, ClinicalTrials.gov, and reference lists of articles.

          Selection criteria

          Randomised, double‐blind clinical trials of single dose, oral ibuprofen plus paracetamol compared with placebo or the same dose of ibuprofen alone for acute postoperative pain in adults.

          Data collection and analysis

          Two review authors independently considered trials for inclusion in the review, assessed quality, and extracted data. We used validated equations to calculate the area under the pain relief versus time curve and derive the proportion of participants with at least 50% of maximum pain relief over six hours. We calculated relative risk (RR) and number needed to treat to benefit (NNT) for ibuprofen plus paracetamol, ibuprofen alone, or placebo. We used information on use of rescue medication to calculate the proportion of participants requiring rescue medication and the weighted mean of the median time to use. We also collected information on adverse events.

          Main results

          Searches identified three studies involving 1647 participants. Each of them examined several dose combinations. Included studies provided data from 508 participants for the comparison of ibuprofen 200 mg + paracetamol 500 mg with placebo, 543 participants for the comparison of ibuprofen 400 mg + paracetamol 1000 mg with placebo, and 359 participants for the comparison of ibuprofen 400 mg + paracetamol 1000 mg with ibuprofen 400 mg alone.

          The proportion of participants achieving at least 50% maximum pain relief over 6 hours was 69% with ibuprofen 200 mg + paracetamol 500 mg, 73% with ibuprofen 400 mg + paracetamol 1000 mg, and 7% with placebo, giving NNTs of 1.6 (1.5 to 1.8) and 1.5 (1.4 to 1.7) for the lower and higher doses respectively compared with placebo. For ibuprofen 400 mg alone the proportion was 52%, giving an NNT for ibuprofen 400 mg + paracetamol 1000 mg compared with ibuprofen alone of 5.4 (3.5 to 12).

          Ibuprofen + paracetamol at the 200/500 mg and 400/1000 mg doses resulted in longer times to remedication than placebo. The median time to use of rescue medication was 7.6 hours for ibuprofen 200 mg + paracetamol 500 mg, 8.3 hours with ibuprofen 400 mg + paracetamol 1000 mg, and 1.7 hours with placebo. Fewer participants needed rescue medication with ibuprofen + paracetamol combination than with placebo or ibuprofen alone. The proportion was 34% with ibuprofen 200 mg + paracetamol 500 mg, 25% with ibuprofen 400 mg + paracetamol 1000 mg, and 79% with placebo, giving NNTs to prevent use of rescue medication of 2.2 (1.8 to 2.9) and 1.8 (1.6 to 2.2) respectively compared with placebo. The proportion of participants using rescue medication with ibuprofen 400 mg was 48%, giving an NNT to prevent use for ibuprofen 400 mg + paracetamol 1000 mg compared with ibuprofen alone of 4.3 (3.0 to 7.7).

          The proportion of participants experiencing one or more adverse events was 30% with ibuprofen 200 mg + paracetamol 500 mg, 29% with ibuprofen 400 mg + paracetamol 1000 mg, and 48% with placebo, giving NNT values in favour of the combination treatment of 5.4 (3.6 to 10.5) and 5.1 (3.5 to 9.5) for the lower and higher doses respectively. No serious adverse events were reported in any of the included studies. Withdrawals for reasons other than lack of efficacy were fewer than 5% and balanced across treatment arms.

          Authors' conclusions

          Ibuprofen plus paracetamol combinations provided better analgesia than either drug alone (at the same dose), with a smaller chance of needing additional analgesia over about eight hours, and with a smaller chance of experiencing an adverse event.

          Single dose oral ibuprofen plus paracetamol (acetaminophen) for acute postoperative pain

          Acute pain is often felt soon after injury, and most people who have surgery will have pain of moderate or severe intensity without treatment for their pain. In many, though not all, circumstances, the pain can be treated with oral analgesics. Many oral analgesics are available, and this review is one of a series examining how effective each one is, at particular doses.

          This review examines a combination of fixed doses of ibuprofen and paracetamol (known as acetaminophen in the USA and some parts of the world). Both are commonly used analgesics, which probably work by different mechanisms. We know that combining different analgesics in the same tablet gives good pain relief to more people than either analgesic alone, at the same dose.

          This review found data in three clinical trials, involving 1647 people with moderate or severe pain after having wisdom teeth removed. This is used commonly to test analgesic effectiveness, because results are applicable to other forms of acute pain after trauma.

          Ibuprofen 200 mg plus paracetamol 500 mg or ibuprofen 400 mg plus paracetamol 1000 mg provided effective pain relief for about 7 in 10 (70%) of participants, compared with just under 1 in 10 (7%) of participants with placebo. The analgesic effects lasted longer and there were fewer adverse events with the combinations than with placebo.

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          Author and article information

          Contributors
          andrew.moore@omkltd.org
          Journal
          Cochrane Database Syst Rev
          Cochrane Database Syst Rev
          14651858
          10.1002/14651858
          The Cochrane Database of Systematic Reviews
          John Wiley & Sons, Ltd (Chichester, UK )
          1469-493X
          24 June 2013
          June 2013
          28 May 2019
          : 2013
          : 6
          : CD010210
          Affiliations
          University of Oxford deptPain Research and Nuffield Department of Clinical Neurosciences (Nuffield Division of Anaesthetics) Pain Research UnitChurchill Hospital Oxford UK OX3 7LE
          Oxford UK
          Plymouth UK
          Author notes

          Editorial Group: Cochrane Pain, Palliative and Supportive Care Group.

          Article
          PMC6485825 PMC6485825 6485825 CD010210 CD010210.pub2
          10.1002/14651858.CD010210.pub2
          6485825
          23794268
          686da1f5-e2d2-411d-bdb0-4ace80d72953
          Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
          History
          : 14 November 2012
          Categories
          Medicine General & Introductory Medical Sciences

          Ibuprofen/administration & dosage,Analgesics, Non‐Narcotic,Pain, Postoperative/drug therapy,Humans,Ibuprofen,Acute Pain,Randomized Controlled Trials as Topic,Analgesics, Non‐Narcotic/administration & dosage,Administration, Oral,Pain, Postoperative,Analgesics, Non‐Narcotic/adverse effects,Ibuprofen/adverse effects,Acute Pain/drug therapy,Adult,Drug Combinations,Acetaminophen/adverse effects,Acetaminophen,Acetaminophen/administration & dosage

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