Dataset Information

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.

ABSTRACT: 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?

SUBMITTER: Thybo KH

PROVIDER: S-EPMC6439592 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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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.

Thybo Kasper Højgaard KH Hägi-Pedersen Daniel D Dahl Jørgen Berg JB Wetterslev Jørn J Nersesjan Mariam M Jakobsen Janus Christian JC Pedersen Niels Anker NA Overgaard Søren S Schrøder Henrik M HM Schmidt Harald H Bjørck Jan Gottfrid JG Skovmand Kamilla K Frederiksen Rune R Buus-Nielsen Morten M Sørensen Charlotte Voss CV Kruuse Laura Smedegaard LS Lindholm Peter P Mathiesen Ole O

JAMA 20190201 6

<h4>Importance</h4>Multimodal postoperative analgesia is widely used but lacks evidence of benefit.<h4>Objective</h4>Investigate beneficial and harmful effects of 4 nonopioid analgesics regimens.<h4>Design, setting, and participants</h4>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.<h4>Interventions ...[more]

PMID: 30747964

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Project description:ObjectivesTo evaluate the efficacy of intravenous (IV) ibuprofen (Caldolor) administration in the management of acute pain in orthopedic trauma patients and to minimize opioid use.DesignRandomized controlled trial, double-blind, parallel, placebo-controlled.SettingLevel 1 Trauma Center.PatientsA total of 99 consecutive orthopedic trauma patients with fractures of the ribs, face, extremities, and/or pelvis were randomized to receive either 800 mg IV ibuprofen (53 patients) or placebo (44 patients) administered every 6 hours for a total of 8 doses within 48 hours of admission and the same PRN medications along with 20-mg IV/PO Pepcid twice a day. To establish pain reduction efficacy, the analysis was consequently performed in the modified intent-to-treat group that included 74 randomized subjects with a baseline pain score greater than 2. The primary outcomes were reduction in opioid consumption and decrease in pain intensity (PI).InterventionAdministration of study medications.Outcome measurementsPI measured by Numerical Rating Scale, opioid consumption adjusted to morphine equivalent dose, and time to first narcotic administration.ResultsThe 2 groups had comparable baseline characteristics: age, sex distribution, mechanism of injury, type of injury, injury severity score, and PI. IV ibuprofen statistically significantly reduced opioid consumption compared with placebo during the initial 48-hour period (P = 0.017). PI calculated as PI differences was statistically different only at 8-hour interval after Caldolor administration. Time to first narcotic medication was significantly longer in the Caldolor group (hazard ratio: 1.640; 95% confidence interval, 1.009-2.665; P = 0.046).ConclusionsIV ibuprofen provided adequate analgesia, prolonged time to first narcotic administration, and was opioid-sparing for the treatment of pain in orthopedic trauma patients, which makes Caldolor a recommended candidate for managing acute pain in the diverse orthopaedic trauma population.Level of evidenceTherapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Project description:ImportanceAcetaminophen (paracetamol) and ibuprofen are the most widely prescribed and available over-the-counter medications for management of fever and pain in children. Despite the common use of these medications, treatment recommendations for young children remain divergent.ObjectiveTo compare acetaminophen with ibuprofen for the short-term treatment of fever or pain in children younger than 2 years.Data sourcesSystematic search of the databases MEDLINE, Embase, CINAHL, and the Cochrane Central Register of Controlled Trials and the trial registers ClinicalTrials.gov and the Australian New Zealand Clinical Trials Registry from inception to March 2019, with no language limits.Study selectionStudies of any design that included children younger than 2 years and directly compared acetaminophen with ibuprofen, reporting antipyretic, analgesic, and/or safety outcomes were considered. There were no limits on length of follow-up.Data extraction and synthesisFollowing the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guideline, 2 authors independently extracted data and assessed quality. Data were pooled using a fixed-effects method if I2 was less than 50% and using a random-effects method if I2 was 50% or greater.Main outcomes and measuresThe primary outcomes were fever or pain within 4 hours of treatment onset. Safety outcomes included serious adverse events, kidney impairment, gastrointestinal bleeding, hepatotoxicity, severe soft tissue infection, empyema, and asthma and/or wheeze.ResultsOverall, 19 studies (11 randomized; 8 nonrandomized) of 241 138 participants from 7 countries and various health care settings (hospital-based and community-based) were included. Compared with acetaminophen, ibuprofen resulted in reduced temperature at less than 4 hours (4 studies with 435 participants; standardized mean difference [SMD], 0.38; 95% CI, 0.08-0.67; P = .01; I2 = 49%; moderate quality evidence) and at 4 to 24 hours (5 studies with 879 participants; SMD, 0.24; 95% CI, 0.03-0.45; P = .03; I2 = 57%; moderate-quality evidence) and less pain at 4 to 24 hours (2 studies with 535 participants; SMD, 0.20; 95% CI, 0.03-0.37; P = .02; I2 = 25%; moderate-quality evidence). Adverse events were uncommon. Acetaminophen and ibuprofen appeared to have similar serious adverse event profiles (7 studies with 27 932 participants; ibuprofen vs aceteminophen: odds ratio, 1.08; 95% CI, 0.87-1.33; P = .50, I2 = 0%; moderate-quality evidence).Conclusions and relevanceIn this study, use of ibuprofen vs acetaminophen for the treatment of fever or pain in children younger than 2 years was associated with reduced temperature and less pain within the first 24 hours of treatment, with equivalent safety.

Dataset Information

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.

Publications

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.

Similar Datasets

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