Acetaminophen or Nonsteroidal Anti-Inflammatory Drugs in Acute Musculoskeletal Trauma: A Multicenter, Double-Blind, Randomized, Clinical Trial - 21/02/18
, Philipp Lirk, PhD b, Helma Goddijn, MSc a, Edwin Vandewalle, MD f, Erik Schinkel, MD h, Susan Van Dieren, PhD c, E. Marleen Kemper, PhD d, Markus W. Hollmann, PhD b, J. Carel Goslings, PhD e, gAbstract |
Study objective |
We determine whether pain treatment with acetaminophen was not inferior to nonsteroidal anti-inflammatory drugs or the combination of both in minor musculoskeletal trauma.
Methods |
The Paracetamol or NSAIDs in Acute Musculoskeletal Trauma Study was a double-blind, randomized, clinical trial conducted in 2 general practices and 2 emergency departments in the Netherlands. A total of 547 adults, aged 18 years and older, with acute blunt minor musculoskeletal extremity trauma were randomly assigned in a 1:1:1 ratio to acetaminophen 4,000 mg/day, diclofenac 150 mg/day, or acetaminophen 4,000 mg/day+diclofenac 150 mg/day during 3 consecutive days. Patients, health care staff, and outcome assessors were blinded for treatment allocation. Follow-up for each patient was 30 days. Primary outcome measures were between-group differences in mean numeric rating scale (NRS) pain scores in rest and with movement at 90 minutes after initial drug administration compared with baseline pain scores with a predefined noninferiority margin of 0.75 NRS points. Secondary outcomes included NRS pain scores during 3 consecutive days and need for additional analgesia.
Results |
One hundred eighty-two patients were treated with acetaminophen, 183 with diclofenac, and 182 with combination treatment. Intention-to-treat analysis revealed mean NRS reduction in rest –1.23 (95% confidence interval [CI] –1.50 to –0.95) and –1.72 (95% CI –2.01 to –1.44) with movement, both for acetaminophen at 90 minutes compared with baseline. Pairwise comparison in rest with diclofenac showed a difference of –0.027 (97.5% CI –0.45 to 0.39) and –0.052 (97.5% CI –0.46 to 0.36) for combination treatment. With movement, these numbers were –0.20 (97.5% CI –0.64 to 0.23) and –0.39 (97.5% CI –0.80 to 0.018), respectively. All differences were well below the predefined noninferiority margin.
Conclusion |
Pain treatment with acetaminophen was not inferior to that with diclofenac or the combination of acetaminophen and diclofenac in acute minor musculoskeletal extremity trauma, both in rest and with movement.
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| Dr. Lirk is currently affiliated with the Department of Anesthesiology, Brigham and Women’s Hospital, Boston, MA. |
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| Please see page 358 for the Editor’s Capsule Summary of this article. |
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| Supervising editor: Steven M. Green, MD |
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| Author contributions: MLR, PL, HG, EMK, MWH, and JCG designed the trial and obtained research funding. MWH and JCG supervised the conduct of the trial. MLR and HG recruited patients and collected data in the Academic Medical Center and in Gein, ES did so at Wynia & Schinkel, and EV did so in the VU Medical Center. EMK was responsible for management, packing, and distribution of study medication. SVD performed the statistical analyses. MLR drafted the article, had full access to all study data, and had final responsibility for the decision to submit for publication. All authors contributed substantially to article revision. MLR 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 ZonMw (The Netherlands Organization for Health Research and Development), grant 836011015. |
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| Trial registration numbers: NTR3982 (Dutch Trial Register) and 2013-000381-11 (European Clinical Trial Database) |
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| The funder of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. |
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| A podcast for this article is available at www.annemergmed.com. |
Vol 71 - N° 3
P. 357 - mars 2018 Retour au numéro
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