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      Journal of Pain Research (submit here)

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

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          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 events. Daily opioid consumption was assessed during treatment.

          Results

          Among meloxicam IV-treated subjects, 64.7% experienced ≥1 AE versus 68.8% of placebo-treated subjects. Investigators assessed most AEs to be mild or moderate in intensity and unrelated to treatment. Total opioid consumption (36.8 mg versus 50.3 mg IV morphine equivalent dose; P=0.0081) and opioid consumption during time points 0‒24, 24‒48, 0‒48, and 0‒72 hrs were statistically significantly lower in the meloxicam IV group.

          Conclusion

          Meloxicam IV demonstrated no significant differences in the number and frequency of AEs versus placebo in subjects following orthopedic surgery. Opioid consumption was reduced in the meloxicam IV group versus placebo.

          Trial registration

          ClinicalTrials.gov (Identifier: NCT02720692).

          Most cited references24

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          Paracetamol and selective and non-selective non-steroidal anti-inflammatory drugs for the reduction in morphine-related side-effects after major surgery: a systematic review.

          Non-opioid analgesics, paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs), or cyclo-oxygenase 2 (COX-2) inhibitors are often given along with morphine as part of multimodal analgesia after major surgery. We have undertaken a systematic review and a mixed treatment comparison (MTC) analysis in order to determine explicitly which class of non-opioid analgesic, paracetamol, NSAIDs, or COX-2 inhibitors is the most effective in reducing morphine consumption and morphine-related adverse effects. Sixty relevant studies were identified. The MTC found that when paracetamol, NSAIDs, or COX-2 inhibitors were added to patient-controlled analgesia (PCA) morphine, there was a statistically significant reduction in morphine consumption: paracetamol [mean difference (MD) -6.34 mg; 95% credibility interval (CrI) -9.02, -3.65], NSAIDs (MD -10.18; 95% CrI -11.65, -8.72), and COX-2 inhibitors (MD -10.92; 95% CrI -12.77, -9.08). There was a significant reduction in nausea and postoperative nausea and vomiting with NSAIDs compared with placebo (odds ratio 0.70; 95% CrI 0.53, 0.88) but not for paracetamol or COX-2 inhibitors, nor for NSAIDs compared with paracetamol or COX-2 inhibitors. There was no statistically significant difference in sedation between any intervention and comparator. On the basis of six trials (n=695), 2.4% of participants receiving an NSAID experienced surgical-related bleeding compared with 0.4% with placebo. The MTC found that there is a decrease in 24 h morphine consumption when paracetamol, NSAID, or COX-2 inhibitors are given in addition to PCA morphine after surgery, with no clear difference between them. Similarly, the benefits in terms of reduction in morphine-related adverse effects do not strongly favour one of the three non-opioid analgesics.
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            Postoperative pain control.

            Prevention and control of postoperative pain are essential. Inadequate treatment of postoperative pain continues to be a major problem after many surgeries and leads to worse outcomes, including chronic postsurgical pain. Optimal management of postoperative pain requires an understanding of the pathophysiology of pain, methods available to reduce pain, invasiveness of the procedure, and patient factors associated with increased pain, such as anxiety, depression, catastrophizing, and neuroticism. Use of a procedure-specific, multimodal perioperative pain management provides a rational basis for enhanced postoperative pain control, optimization of analgesia, decrease in adverse effects, and improved patient satisfaction.
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              Effects of nonsteroidal antiinflammatory drugs on patient-controlled analgesia morphine side effects: meta-analysis of randomized controlled trials.

              Nonsteroidal antiinflammatory drugs (NSAIDs) are commonly combined with intravenous morphine patient-controlled analgesia to relieve postoperative pain. NSAIDs have a documented 30-50% sparing effect on morphine consumption. However, most of the studies have not demonstrated a decrease in morphine adverse effects. A meta-analysis of randomized controlled trials was performed to evaluate the risk of morphine adverse effects in patients treated with NSAIDs. Twenty-two prospective, randomized, double-blind studies including 2,307 patients were selected. NSAIDs decreased significantly postoperative nausea and vomiting by 30%, nausea alone by 12%, vomiting alone by 32% and sedation by 29%. A regression analysis yielded findings indicating that morphine consumption was positively correlated with the incidence of nausea and vomiting. Pruritus, urinary retention, and respiratory depression were not significantly decreased by NSAIDs.
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                Author and article information

                Journal
                J Pain Res
                J Pain Res
                JPR
                jpainres
                Journal of Pain Research
                Dove
                1178-7090
                21 January 2020
                2020
                : 13
                : 221-229
                Affiliations
                [1 ]OrthoArizona , Gilbert, AZ, USA
                [2 ]Phoenix Clinical Research , Tamarac, FL, USA
                [3 ]University Orthopedics Center , Altoona, PA, USA
                [4 ]Shoals Clinical Research Associates, LLC , Florence, SC, USA
                [5 ]Baudax Bio, Inc ., Malvern, PA, USA
                [6 ]Clinical Statistics Consulting , Blue Bell, PA, USA
                Author notes
                Correspondence: Randall J Mack Baudax Bio, Inc ., 490 Lapp Road, Malvern, PA 19355, USATel +1 484 395 2470Fax +1 484 395 2471 Email rmack@baudaxbio.com
                Author information
                http://orcid.org/0000-0001-7550-5845
                Article
                216219
                10.2147/JPR.S216219
                6982445
                348e3b6d-e09d-4530-b7e1-01ed8756a08a
                © 2020 Sharpe et al.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                History
                : 23 May 2019
                : 21 December 2019
                Page count
                Figures: 1, Tables: 7, References: 34, Pages: 9
                Funding
                Funding for this research was provided by Baudax Bio formerly Recro Pharma, Inc., Malvern, PA, USA.
                Categories
                Original Research

                Anesthesiology & Pain management
                meloxicam iv,nsaid,orthopedic surgery,postoperative pain,safety
                Anesthesiology & Pain management
                meloxicam iv, nsaid, orthopedic surgery, postoperative pain, safety

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