Main Outcomes and Measures Two co–primary outcomes: 24-hour morphine consumption using patient-controlled analgesia in pairwise comparisons between the 4 groups (multiplicity-adjusted thresholds for statistical significance, P < .0042 minimal clinically important difference, 10 mg), and proportion of patients with 1 or more serious adverse events (SAEs) within 90 days (multiplicity-adjusted thresholds for statistical significance, P < .025). Interventions Participants were randomized to receive paracetamol (acetaminophen) 1000 mg plus ibuprofen 400 mg (n = 136 PCM + IBU), paracetamol 1000 mg plus matched placebo (n = 142 PCM), ibuprofen 400 mg plus matched placebo (n = 141 IBU), or half-strength paracetamol 500 mg plus ibuprofen 200 mg (n = 140 HS–PCM + IBU) orally every 6 hours for 24 hours postoperatively, starting 1 hour before surgery. Final date of follow-up was January 1, 2018. Objective Investigate beneficial and harmful effects of 4 nonopioid analgesics regimens.ĭesign, Setting, and Participants Randomized, blinded, placebo-controlled, 4-group trial in 6 Danish hospitals with 90-day follow-up that included 556 patients undergoing total hip arthroplasty (THA) from December 2015 to October 2017. Importance Multimodal postoperative analgesia is widely used but lacks evidence of benefit. Meaning Although the combined use of paracetamol and ibuprofen reduced immediate postoperative morphine consumption compared with paracetamol alone in patients undergoing THA, ibuprofen alone resulted in comparable pain control without increasing SAEs, suggesting that ibuprofen alone may be a reasonable option. The percentage of patients with SAEs for those in any of the ibuprofen groups vs paracetamol alone was 15% vs 11%, which was not statistically significant. Question Does paracetamol (acetaminophen) combined with ibuprofen reduce postoperative morphine usage relative to the use of each drug alone in patients undergoing total hip arthroplasty (THA), and does ibuprofen increase the incidence of serious adverse events (SAEs)?įindings In this randomized clinical trial that included 556 patients who underwent THA, morphine usage in the first 24 hours was statistically significantly lower for the combination of paracetamol 1000 mg and ibuprofen 400 mg than for either alone however, the combined medications did not meet the prespecified threshold for clinically important postoperative morphine reduction (10 mg) compared with ibuprofen alone. Shared Decision Making and Communication.Scientific Discovery and the Future of Medicine.Health Care Economics, Insurance, Payment.Clinical Implications of Basic Neuroscience.Challenges in Clinical Electrocardiography.Analyses on the Strictly Per-Protocol Population of Exploratory Outcomes Analyses on the Strictly Per-Protocol Population of Secondary OutcomesĮTable 13. Adjusted Analyses of Secondary OutcomesĮTable 12. Analyses on the Strictly Per-Protocol Population for the Co–Primary Outcome of Morphine ConsumptionĮTable 11. Analyses Adjusted for Age, Sex, Prior Use of Paracetamol, and Prior Use of NSAIDs for the Co–Primary Outcome of Morphine Consumption With 95% CIsĮTable 10. Withdrawn Because of Opioid-Associated Adverse Effects or Insufficient Pain TreatmentĮTable 9. Patients Taking NSAIDs in the Follow-up PeriodĮTable 7 Strictly Per-Protocol PopulationĮTable 8. Interaction Between Site and Intervention for the Primary Outcomes of Patients With 1 or More Modified SAEsĮTable 3. Interaction Between Site and Intervention for Pairwise Comparisons of Primary and Secondary OutcomesĮTable 2. Abstracts Written Before Breaking the Randomization CodeĮAppendix 4. Complete List of Inclusion and Exclusion CriteriaĮAppendix 2.
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