Safety and Efficacy of Perioperative Intravenous Meloxicam for Moderate-to-Severe Pain Management in Total Knee Arthroplasty: A Randomized Clinical Trial

被引:7
作者
Berkowitz, Richard D. [1 ]
Steinfeld, Richard [2 ]
Sah, Alexander P. [3 ]
Mack, Randall J. [4 ]
McCallum, Stewart W. [4 ]
Du, Wei [5 ]
Black, Libby K. [4 ]
Freyer, Alex [4 ]
Coyle, Erin [4 ]
机构
[1] Univ Orthoped & Joint Replacement Ctr, Tamarac, FL USA
[2] Orthopaed Ctr Vero Beach, Vero Beach, FL USA
[3] Inst Joint Restorat & Res, Fremont, CA USA
[4] Baudax Bio Inc, 490 Lapp Rd, Malvern, PA 19355 USA
[5] Clin Stat Consulting, Blue Bell, PA USA
关键词
Acute Pain; Health Economic Outcomes; Intravenous Meloxicam; Safety; Postsurgical Pain; NONSTEROIDAL ANTIINFLAMMATORY DRUGS; AMERICAN-SOCIETY; NANOCRYSTAL FORMULATION; PRACTICE GUIDELINES; POSTOPERATIVE PAIN; ANALGESIC EFFICACY; ENHANCED RECOVERY; SURGERY; PLACEBO; ANESTHESIA;
D O I
10.1093/pm/pnab016
中图分类号
R614 [麻醉学];
学科分类号
100217 ;
摘要
Objective. To evaluate the effect of perioperative meloxicam IV 30mg on opioid consumption in primary total knee arthroplasty (TKA). Design. Multicenter, randomized, double-blind, placebo-controlled trial. Subjects. In total, 181 adults undergoing elective primary TKA. Methods. Subjects received meloxicam 30mg or placebo via an IV bolus every 24 hours, the first dose administered prior to surgery as part of a multimodal pain management protocol. The primary efficacy parameter was total opioid use from end of surgery through 24 hours. Results. Meloxicam IV was associated with less opioid use versus placebo during the 24 hours after surgery (18.9 +/- 1.32 vs 27.7 +/- 1.37mg IV morphine equivalent dose; P<0.001) and was superior to placebo on secondary endpoints, including summed pain intensity (first dose to 24 hours postdosing, first dose to first assisted ambulation, and first dose to discharge) and opioid use (48-72 hrs., 0-48 hrs., 0-72 hrs., hour 0 to end of treatment, and the first 24 hours after discharge). Adverse events (AEs) were reported for 69.9% and 92.0% of the meloxicam IV and placebo groups, respectively; the most common AEs were nausea (40% vs. 59%), vomiting (16% vs 22%), hypotension (14% vs 15%), pruritus (15% vs 11%), and constipation (11% vs 13%). Conclusions. Perioperative meloxicam IV 30mg as part of a multimodal analgesic regimen for elective primary TKA reduced opioid consumption in the 24-hour period after surgery versus placebo and was associated with a lower incidence of AEs typically associated with opioid use.
引用
收藏
页码:1261 / 1271
页数:11
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