Preoperative Intravenous Meloxicam for Moderate-To-Severe Pain in the Immediate Post-Operative Period: A Phase IIIB Randomized Clinical Trial in 55 Patients Undergoing Primary Open or Laparoscopic Colorectal Surgery with Bowel Resection and/or Anastomosis

Abstract

Aim: Evaluate safety/efficacy of intravenous meloxicam in a colorectal enhanced recovery after surgery protocol. Methods: Adults undergoing primary open or laparoscopic colorectal surgery with bowel resection and/or anastomosis received meloxicam IV 30 mg (n = 27) or placebo (n = 28) once daily beginning 30 min before surgery. Results: Adverse events: meloxicam IV, 85%; placebo, 93%. Adverse events commonly associated with opioids: 41 versus 61% – including nausea (33 vs 50%), vomiting (19 vs 18%) and ileus (4 vs 18%). Wound healing satisfaction scores (physician-rated), clinical laboratory findings and vital signs were similar in both groups. No anastomotic leaks were reported. Opioid consumption, postoperative pain intensity, length of stay and times to first bowel sound, first flatus and first bowel movement were significantly lower with meloxicam IV versus placebo. Most subjects (>92%) were satisfied with postoperative pain medication. Conclusion: Meloxicam IV was generally well tolerated and associated with decreased opioid consumption, lower resource utilization and functional benefits.

Clinical Trial Registration: NCT03323385 (ClinicalTrials.gov)

Keywords::

• acute pain
• colorectal surgery
• healthcare resource utilization
• intravenous meloxicam
• safety
• tolerability

Supplementary data

To view the supplementary data that accompany this paper please visit the journal website at: www.tandfonline.com/doi/suppl/10.2217/pmt-2020-0061

Author contributions

JD Silinsky and JE Marcet contributed to study design and implementation; managed subjects and helped with data acquisition; helped draft the article and/or critically reviewed it for important intellectual content; approved the final article. VR Anupindi, SU Karkare, DR Shah, W Du and A Freyer contributed to study design and implementation; provided guidance on data analysis and interpretation; helped draft the article and/or critically review it for important intellectual content; approved the final article. RJ Mack, SW McCallum and LK Black contributed to study design, data analyses plan and reporting of the data/results; provided guidance on data interpretation; helped draft the article and/or critically review it for important intellectual content; approved the final article.

Acknowledgments

The authors would like to thank CP Delaney, who participated in the design of the study and its implementation.

Meeting presentations

Limited portions of the material reported in this manuscript were accepted for presentation at the American Society of Colon and Rectal Surgeons (ASCRS) Annual Scientific Meeting in Boston, MA, 6–10 June 2020, and at Digestive Disease Week (DDW) 2020 in Chicago, IL, 2–5 May 2020. The ASCRS poster focuses on clinical outcomes and the DDW poster focuses on economic outcomes.

Financial & competing interests disclosure

The clinical trial and its publication were supported by Baudax Bio, Inc., formerly Recro Pharma, Inc., Malvern, PA, USA. VR Anupindi, SU Karkare and DR Shah are employees of IQVIA and received funding for the study from Baudax Bio, formerly Recro Pharma; SU Karkare was an employee of IQVIA at the time of the study; SW McCallum, RJ Mack, A Freyer and LK Black are employees and stockholders of Baudax Bio, formerly Recro Pharma; W Du is a consultant (statistical analysis) for Baudax Bio, formerly Recro Pharma. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Medical writing support was provided by B Fulton and S Martin of The Medicine Group, New Hope, PA, USA, and was funded by Baudax Bio Inc., formerly Recro Pharma, Malvern, Pennsylvania.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.

Data sharing statement

The authors certify that this manuscript reports original clinical trial data, NCT03323385. Individual, de-identified participant data will not be available. Data will be available to the public at https://clinicaltrials.gov/ct2/show/NCT03323385 for the duration of 2020.

Additional information

Funding

The clinical trial and its publication were supported by Baudax Bio, Inc., formerly Recro Pharma, Inc., Malvern, PA, USA. VR Anupindi, SU Karkare and DR Shah are employees of IQVIA and received funding for the study from Baudax Bio, formerly Recro Pharma; SU Karkare was an employee of IQVIA at the time of the study; SW McCallum, RJ Mack, A Freyer and LK Black are employees and stockholders of Baudax Bio, formerly Recro Pharma; W Du is a consultant (statistical analysis) for Baudax Bio, formerly Recro Pharma. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Medical writing support was provided by B Fulton and S Martin of The Medicine Group, New Hope, PA, USA, and was funded by Baudax Bio Inc., formerly Recro Pharma, Malvern, Pennsylvania.