Safety, Tolerability, and Effect on Opioid Use of Meloxicam IV Following Orthopedic Surgery.

ABSTRACT:

Objective

A Phase 3 randomized multicenter, double-blind, placebo-controlled trial (NCT02720692) compared once-daily intravenous (IV) meloxicam 30 mg to placebo, when added to the standard of care pain management regimens, in adults with moderate-to-severe pain following major elective surgery and concluded that meloxicam IV had a safety profile similar to placebo and reduced opioid consumption.

Methods

In this post hoc subgroup analysis of orthopedic surgery subjects, 379 subjects received meloxicam IV 30 mg or IV-administered placebo every 24 hrs for ≤7 doses. Safety was assessed via AEs, laboratory tests, vital signs, and ECG, with an emphasis on specific AEs, including injection site reactions, bleeding, cardiovascular, hepatic, renal, thrombotic, and wound healing event

SUBMITTER: Sharpe KP 

PROVIDER: S-EPMC6982445 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature