The Shortened Infusion Time of Intravenous Ibuprofen Part 1: A Multicenter, Open-label, Surveillance Trial to Evaluate Safety and Efficacy

作者: Sergio D Bergese , Keith Candiotti , Sabry S Ayad , Suren Soghomonyan , Tong J Gan

DOI: 10.1016/J.CLINTHERA.2014.12.004

关键词:

摘要: Abstract Purpose The main purpose of the study was to determine safety profile and efficacy intravenous ibuprofen administered over 5 10 minutes for treatment pain or fever in hospitalized patients. Current evidence supports use infusions control reduce opioid requirements associated with surgical pain. dosing guidelines recommend that drug be 30 minutes. However, a more rapid infusion might yield additional benefits. shortened time requires study. Methods This Phase IV multicenter, open-label, surveillance clinical Thirteen centers located United States enrolled total 150 adult patients fever. Patients experiencing received 800 mg infused every 6 hours up 24 (4 doses) 400 4 (6 doses). Vital signs, adverse events, scores were assessed. exclusion criteria included inadequate access; younger than 18 years age; history allergy hypersensitivity any component ibuprofen, aspirin, other nonsteroid anti-inflammatory drugs; active hemorrhage clinically significant bleeding; pregnancy nursing; perioperative period setting coronary artery bypass graft surgery. Findings Adverse events reported 43 (29%). most common experienced by site 22 (15%) flatulence (8 [5%]). Four (3%) discontinued due infusion-site In fever, temperature decreased from baseline (mean [SD] reduction 1.5 [1.25]°F). pain, patient-reported visual analog scale 27.1 [31.29] mm). Implications demonstrates administration is well tolerated as an effective

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