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
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 hrs 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.