Efficacy and Safety of Intravenous Meloxicam in Subjects with Moderate-to-Severe Pain Following Abdominoplasty
Neil K. Singla, MD; Matthew Bindewald, MD; Sonia Singla, DO; David Leiman, MD; Harold Minkowitz, MD; Stewart W. McCallum, MD; Randall J. Mack, BS; Rosemary Keller, PhD, CRNP; Alex Freyer, PharmD; Wei Du, PhD
Background: A nanocrystal intravenous (IV) formulation of meloxicam is being studied with the aim of providing postoperative analgesia.
Methods: This randomized, multicenter, double-blind, placebo-controlled trial evaluated meloxicam IV 30 mg or placebo (≤ 3 doses) in 219 subjects undergoing abdominoplasty. The primary endpoint was the summed pain intensity difference over 24 hours postdose (SPID24).
Results: Meloxicam IV–treated subjects had a statistically significant reduction in the least squares mean of SPID24 compared with placebo-treated subjects (‒4,262.1 versus ‒3,535.7; P = 0.0145). Meloxicam IV was associated with statistically significant differences over placebo on several other secondary endpoints, including other SPID intervals (ie, SPID12, SPID48, and SPID24‒48), achievement of perceptible pain relief, the proportion of subjects with a ≥ 30% improvement in the first 24 hours, and Patient Global Assessment of pain at hour 48. Meloxicam IV was also associated with a reduction in the number of subjects receiving opioid rescue medication during hours 24–48 and the total number of doses of opioid rescue analgesia. Meloxicam IV was generally well tolerated, with the numbers and frequencies of adverse events similar to that of the placebo group. There was no evidence of an increased risk of adverse events commonly associated with nonsteroidal anti-inflammatory drugs including bleeding, thrombotic, cardiovascular, renal, hepatic, cardiovascular, injection site, and wound healing events.
Conclusion: Meloxicam IV provided sustained pain relief and generally was well tolerated in subjects with moderate-to-severe pain following abdominoplasty. (Plast Reconstr Surg Glob Open 2018;6:e1846; doi: 10.1097/GOX.0000000000001846; Published online 19 June 2018.)
INTRODUCTION – Abdominoplasty is 1 of the most frequently performed cosmetic surgeries in the United States, and the number of procedures has substantially increased in recent years from 62,713 in 2000 to 127,633 in 2016.1 For such procedures, safe and effective pain control is an important component of postoperative patient care.2 Postoperative pain reduction can lead to earlier mobilization, shortened hospital stays, reduced hospital costs, quicker return to normal activities, and increased patient satisfaction.3,4 Although opioids, in combination with other forms of analgesia, have been a mainstay of perioperative pain control, there has been an increased emphasis on the use of alternative medications, given the potential risks associated with these agents (eg, adverse events [AEs] such as nausea/vomiting, constipation, pruritus, sedation, respiratory depression, development of dependence).5–8 Multimodal pain management approaches to the treatment of postoperative pain (eg, use of synergistic combinations of analgesics) are gaining acceptance in a variety of surgical procedures.7–9 Nonsteroidal anti-inflammatory drugs (NSAIDs) are considered an important component of such regimens.7,8
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