دورية أكاديمية
أعرض في EDS

Efficacy and Safety of an Intravenous Acetaminophen/Ibuprofen Fixed-dose Combination After Bunionectomy: a Randomized, Double-blind, Factorial, Placebo-controlled Trial.

التفاصيل البيبلوغرافية
العنوان: Efficacy and Safety of an Intravenous Acetaminophen/Ibuprofen Fixed-dose Combination After Bunionectomy: a Randomized, Double-blind, Factorial, Placebo-controlled Trial.
المؤلفون: Daniels SE; Optimal Research LLC, Austin, TX, USA., Playne R; AFT Pharmaceuticals Ltd, Auckland, New Zealand., Stanescu I; AFT Pharmaceuticals Ltd, Auckland, New Zealand. Electronic address: ioana@aftpharm.com., Zhang J; AFT Pharmaceuticals Ltd, Auckland, New Zealand., Gottlieb IJ; Chesapeake Research Group, Pasadena, MD, USA., Atkinson HC; AFT Pharmaceuticals Ltd, Auckland, New Zealand.
المصدر: Clinical therapeutics [Clin Ther] 2019 Oct; Vol. 41 (10), pp. 1982-1995.e8. Date of Electronic Publication: 2019 Aug 22.
نوع المنشور: Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: Excerpta Medica Country of Publication: United States NLM ID: 7706726 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1879-114X (Electronic) Linking ISSN: 01492918 NLM ISO Abbreviation: Clin Ther Subsets: MEDLINE
أسماء مطبوعة: Publication: 1998- : Belle Mead, NJ, : Excerpta Medica
Original Publication: Princeton, N. J., Excerpta Medica.
مواضيع طبية MeSH: Acetaminophen/*administration & dosage , Analgesics/*administration & dosage , Anti-Inflammatory Agents, Non-Steroidal/*administration & dosage , Bunion/*surgery , Ibuprofen/*administration & dosage, Adolescent ; Adult ; Aged ; Analgesia ; Double-Blind Method ; Drug Combinations ; Female ; Humans ; Infusions, Intravenous ; Male ; Middle Aged ; Pain Management ; Pain, Postoperative/drug therapy ; Treatment Outcome ; Young Adult
مستخلص: Purpose: Multimodal analgesia with acetaminophen and/or nonsteroidal anti-inflammatory drugs is recommended for the treatment of postoperative pain. Although oral fixed-dose combinations (FDCs) are available, parenteral administration may be clinically justified. The goal of this study was to investigate the clinical efficacy and safety of an intravenous FDC of ibuprofen and acetaminophen after bunionectomy.
Methods: This study was a prospective, randomized, double-blind, multicenter, placebo-controlled factorial clinical trial conducted at 2 clinical research centers in the United States between November 2016 and June 2017. Eligible patients (male and female subjects, aged 18-65 years, reporting pain intensity levels ≥40 mm on a 100-mm visual analog scale (VAS) after distal, first metatarsal bunionectomy) were randomized (3:3:3:2) to receive the FDC (ibuprofen 300 mg + acetaminophen 1000 mg), ibuprofen 300 mg, acetaminophen 1000 mg, or placebo (vehicle), administered as 15-minute intravenous infusions every 6 hours for 48 hours. The primary efficacy end point was the time-adjusted sum of pain intensity differences from baseline over 48 hours (SPID 48 ). In addition to VAS pain intensity scores, pain relief scores, time to perceptible and meaningful pain relief, the use of rescue medication, and participant's global evaluations of the study drug were recorded. Adverse events occurring during the 48-hour treatment period were included in the safety analysis.
Findings: A total of 276 participants were enrolled; most were female (82%), the mean age was 42.4 years, and the median baseline VAS was 67 mm, indicating moderate to severe pain. SPID 48 was significantly higher for the FDC (23.4 [2.5] mm) than for ibuprofen (9.5 [2.5] mm), acetaminophen (10.4 [2.5] mm), and placebo (-1.3 [3.1] mm; all, P < 0.001). The superior analgesic effect of the FDC was supported by a range of secondary end points, including reduced opioid usage rates (75% for FDC, 92% for ibuprofen, 93% for acetaminophen, and 96% for placebo; all, P < 0.005). The safety profile of the FDC was comparable to that of intravenous ibuprofen or acetaminophen alone. Three participants withdrew from the study due to adverse events: 2 in the ibuprofen group and 1 in the acetaminophen group.
Implications: The study found that repeated administration of an intravenous FDC of ibuprofen and acetaminophen provided statistically significant improvement in SPID 48 over comparable doses of either monotherapy without an increase in adverse events. ClinicalTrials.gov identifier: NCT02689063.
(Copyright © 2019. Published by Elsevier Inc.)
فهرسة مساهمة: Keywords: acetaminophen; bunionectomy; combination therapy; ibuprofen; postoperative pain
سلسلة جزيئية: ClinicalTrials.gov NCT02689063
المشرفين على المادة: 0 (Analgesics)
0 (Anti-Inflammatory Agents, Non-Steroidal)
0 (Drug Combinations)
362O9ITL9D (Acetaminophen)
WK2XYI10QM (Ibuprofen)
تواريخ الأحداث: Date Created: 20190827 Date Completed: 20200623 Latest Revision: 20200623
رمز التحديث: 20231215
DOI: 10.1016/j.clinthera.2019.07.008
PMID: 31447129
قاعدة البيانات: MEDLINE
الوصف
تدمد:1879-114X
DOI:10.1016/j.clinthera.2019.07.008