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

Author:

Berkowitz Richard D1,Steinfeld Richard2,Sah Alexander P3,Mack Randall J4ORCID,McCallum Stewart W4,Du Wei5,Black Libby K4,Freyer Alex4,Coyle Erin4

Affiliation:

1. University Orthopedic and Joint Replacement Center, Tamarac, Florida, USA

2. Orthopaedic Center of Vero Beach, Vero Beach, Florida, USA

3. Institute for Joint Restoration & Research, Fremont, California, USA

4. Baudax Bio Inc., Malvern, Pennsylvania, USA

5. Clinical Statistics Consulting, Blue Bell, Pennsylvania, USA

Abstract

Abstract Objective To evaluate the effect of perioperative meloxicam IV 30 mg 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 30 mg 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 ± 1.37 mg 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 30 mg 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.

Funder

Baudax Bio

Recro Pharma, Inc.

Publisher

Oxford University Press (OUP)

Subject

Anesthesiology and Pain Medicine,Neurology (clinical),General Medicine

Reference47 articles.

1. A qualitative and quantitative needs assessment of pain management for hospitalized orthopedic patients;Cordts;Orthopedics,2011

2. A procedure-specific systematic review and consensus recommendations for postoperative analgesia following total knee arthroplasty;Fischer;Anaesthesia,2008

3. American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: An updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management;Anesthesiology,2012

4. Orthopaedic postoperative pain management;Pasero;J Perianesth Nurs,2007

5. Management of postoperative pain: A clinical practice guideline from the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council;Chou;J Pain,2016

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