Báo cáo y học: " A multi-center, randomized, double-blind, parallel, placebo-controlled trial to evaluate the efficacy, safety, and pharmacokinetics of intravenous ibuprofen for the treatment of fever in critically ill and non-critically ill adults"

Tuyển tập các báo cáo nghiên cứu về y học được đăng trên tạp chí y học quốc tế cung cấp cho các bạn kiến thức về ngành y đề tài: A multi-center, randomized, double-blind, parallel, placebo-controlled trial to evaluate the efficacy, safety, and pharmacokinetics of intravenous ibuprofen for the treatment of fever in critically ill and non-critically ill adults. | Morris et al. Critical Care 2010 14 R125 http content 14 3 R125 c CRITICAL CARE RESEARCH Open Access A multi-center randomized double-blind parallel placebo-controlled trial to evaluate the efficacy safety and pharmacokinetics of intravenous ibuprofen for the treatment of fever in critically ill and non-critically ill adults Peter E Morris 1 John T Promes2 Kalpalatha KGuntupalli3 Patrick E Wright4 and Murray M Arons5 Abstract Introduction Hospitalized patients are often unable to ingest or tolerate oral antipyretics and recently an aqueous formulation of intravenous IV ibuprofen was approved by the US-FDA for the reduction of fever in adults. Methods We evaluated IV ibuprofen to reduce fever exceeding F measured as the percentage of subjects achieving a temperature F at four hours after a single dose of IV ibuprofen vs. placebo. Secondary evaluations included the effect on temperature at 24 hours. Nine sites randomized patients to receive either a placebo or IV ibuprofen 100 200 or 400 mg and patients were given four hours for six doses. Subjects were excluded for platelet count 30 k and or creatinine mg dL. Results At entry there were no significant baseline differences between the IV ibuprofen group and placebo n 120. At four hours the number percentage with T F was Placebo n 9 28 32 100 mg IV ibuprofen n 19 31 61 P 200 mg iV ibuprofen n 21 30 70 P 400 mg IV ibuprofen n 24 31 77 P . A total of 53 120 patients 44 were prospectively defined as critically ill at baseline and similar temperature reductions were observed in this subgroup. There were no statistically significant differences between treatment groups or when compared to placebo in transfusion bleeding renal failure or mortality. Conclusions All doses of IV ibuprofen tested reduced fever at four hours and throughout the first 24 hours of dosing. The 400 mg dose was effective in lowering temperature to normal and maintaining this over the first 24 hours

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