Oral Paracetamol Versus Combination Oral Analgesics for Acute Musculoskeletal Injuries - 19/09/19
Abstract |
Study objective |
We compare paracetamol with a combination of paracetamol, ibuprofen, and codeine for pain relief in acute minor musculoskeletal injuries.
Methods |
This was a prospective, double-blind, randomized, active-controlled, parallel-arm study at an urban tertiary hospital emergency department. Participants were aged 18 to 65 years and had acute (<48 hours) closed limb or trunk injuries with moderate pain (greater than 3/10). A single dose of 1 g of paracetamol, 400 mg of ibuprofen, and 60 mg of codeine was compared with a single dose of 1 g of paracetamol, placebo ibuprofen, and placebo codeine. The minimum detectable difference in pain was taken as 1.3.
Results |
Baseline characteristics and pain were similar. There were clinically detectable reductions in pain at rest at 60 minutes for paracetamol: –1.6; 95% confidence interval (CI) –2.2 to –1.1); n=59 and the combination –2.0; 95% CI –2.5 to –1; n=59; difference –0.4; 95% CI –1.1 to 0.29; P=.26. At 120 minutes, the reduction in pain was –2.4; 95% CI –3.2 to –1.6 for paracetamol (n=30) and –2.9; 95% CI –3.7 to –2.2 for the combination (n=35); difference –0.5; 95% CI –1.6 to 0.5; P=.32. Rescue analgesia was required by 4 of 59 patients in the paracetamol group and 5 of 60 in the combination group (P>.99). More participants in the combination group had adverse events: 14 of 60 versus 5 of 59 in the paracetamol group, relative risk 2.8; 95% CI 1.1 to 7.2. No adverse events were serious.
Conclusion |
Combining oral paracetamol, ibuprofen, and codeine as the initial treatment for pain associated with acute musculoskeletal injuries was not superior to paracetamol alone for pain reduction at 60 minutes or need for rescue analgesia, with more adverse events in the combination group.
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| Please see page 522 for the Editor’s Capsule Summary of this article. |
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| Supervising editor: Steven M. Green, MD. Specific detailed information about possible conflict of interest for individual editors is available at editors. |
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| Author contributions: PJ conceived the study. PJ, JG, MC, and CK designed the trial and obtained research funding. JG, MC, and PJ supervised the conduct of the trial and data collection. JG and MC undertook recruitment of patients and together with PJ, managed the data, including quality control. PJ and CK provided statistical advice on study design and PJ analyzed the data. JG and PJ drafted the manuscript, and all authors contributed substantially to its revision. PJ takes responsibility for the paper as a whole. |
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| All authors attest to meeting the four ICMJE.org authorship criteria: (1) Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND (2) Drafting the work or revising it critically for important intellectual content; AND (3) Final approval of the version to be published; AND (4) Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. |
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| Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (see www.icmje.org). The authors have stated that no such relationships exist. The study was funded by grants from the Auckland District Health Board A+ (study 7983), Auckland, New Zealand, and the Australasian College for Emergency Medicine Morson-Taylor Research Award 2018, Melbourne, Victoria, Australia |
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| Trial registration number: ACTRN 12618000020280 |
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| The researchers had complete independence from funders. All authors, external and internal, had full access to all of the data (including statistical reports and tables) in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. |
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Vol 74 - N° 4
P. 521-529 - octobre 2019 Retour au numéro
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