Effect of Combination of Paracetamol (Acetaminophen) and Ibuprofen vs Either Alone on Patient-Controlled Morphine Consumption in the First 24 Hours After Total Hip Arthroplasty: The PANSAID Randomized Clinical Trial
| Autor: | Kasper Højgaard Thybo, Ole Mathiesen, Rune Frederiksen, Henrik Morville Schrøder, Jan Gottfrid Bjørck, Kamilla Skovmand, Mariam Nersesjan, Daniel Hägi-Pedersen, Jørn Wetterslev, Janus Christian Jakobsen, Laura Smedegaard Kruuse, Morten Buus-Nielsen, Niels Anker Pedersen, Charlotte Voss Sørensen, Harald Schmidt, Søren Overgaard, Peter Lindholm, Jørgen B. Dahl |
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| Rok vydání: | 2019 |
| Předmět: |
Male
Pain Postoperative/drug therapy medicine.medical_treatment Arthroplasty Replacement Hip Administration Oral Ibuprofen Placebo 01 natural sciences law.invention Ibuprofen/administration & dosage 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Double-Blind Method law Acetaminophen/administration & dosage Statistical significance medicine Humans 030212 general & internal medicine Analgesics Non-Narcotic/administration & dosage 0101 mathematics Adverse effect Acetaminophen Aged Pain Measurement Original Investigation Pain Postoperative Analgesics Opioid/administration & dosage Morphine business.industry organic chemicals 010102 general mathematics General Medicine Analgesics Non-Narcotic Middle Aged Arthroplasty Analgesics Opioid Arthroplasty Replacement Hip/adverse effects Morphine/administration & dosage Anesthesia Drug Therapy Combination Female business medicine.drug |
| Zdroj: | Thybo, K H, Hägi-Pedersen, D, Dahl, J B, Wetterslev, J, Nersesjan, M, Jakobsen, J C, Pedersen, N A, Overgaard, S, Schrøder, H M, Schmidt, H, Bjørck, J G, Skovmand, K, Frederiksen, R, Buus-Nielsen, M, Sørensen, C V, Kruuse, L S, Lindholm, P & Mathiesen, O 2019, ' Effect of Combination of Paracetamol (Acetaminophen) and Ibuprofen vs Either Alone on Patient-Controlled Morphine Consumption in the First 24 Hours after Total Hip Arthroplasty : The PANSAID Randomized Clinical Trial ', JAMA-Journal of the American Medical Association, vol. 321, no. 6, pp. 562-571 . https://doi.org/10.1001/jama.2018.22039 |
| ISSN: | 1538-3598 |
| DOI: | 10.1001/jama.2018.22039 |
| Popis: | Importance: Multimodal postoperative analgesia is widely used but lacks evidence of benefit.Objective: Investigate beneficial and harmful effects of 4 nonopioid analgesics regimens.Design, 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. Final date of follow-up was January 1, 2018.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.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 Results: Among 559 randomized participants (mean age, 67 years; 277 [50%] women), 556 (99.5%) completed the trial and were included in the analysis. Median 24-hour morphine consumption was 20 mg (99.6% CI, 0-148) in the PCM + IBU group, 36 mg (99.6% CI, 0-166) for PCM alone, 26 mg (99.6% CI, 2-139) for IBU alone, and 28 mg (99.6% CI, 2-145) for HS-PCM + IBU. The median difference in morphine consumption between the PCM + IBU group vs PCM alone was 16 mg (99.6% CI, 6.5 to 24; P Conclusions and Relevance: Among patients undergoing THA, paracetamol plus ibuprofen significantly reduced morphine consumption compared with paracetamol alone in the first 24 hours after surgery; there was no statistically significant increase in SAEs in the pooled groups receiving ibuprofen alone vs with paracetamol alone. However, the combination did not result in a clinically important improvement over ibuprofen alone, suggesting that ibuprofen alone may be a reasonable option for early postoperative oral analgesia.Trial Registration: ClinicalTrials.gov Identifier: NCT02571361. |
| Databáze: | OpenAIRE |
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