Meloxicam in Mohs Micrographic Surgery

NCT07200544 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 18006
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to explore alternative methods of postoperative pain control in Mohs micrographic surgery. The main aims are:

• To provide more information to the Mohs surgery community regarding postoperative pain control.
• Reducing pain improves the overall comfort and well-being of patients, leading to a better post-operative experience.
• To provide patients with an alternative and potentially superior NSAID for pain control (compared to standard-of-care ibuprofen). Researchers will compare 1) a single of dose Meloxicam 7.5 mg, followed by acetaminophen 500 mg; 2) a single dose of Meloxicam 15 mg, followed by acetaminophen 500 mg; 3) a single dose of acetaminophen 500 mg, followed by alternating ibuprofen 200 mg and acetaminophen 500 mg to see which better moderate pain control and patient satisfaction. Participants will be asked to complete pain and patient satisfaction surveys.

Conditions

Postoperative Pain, Acute; Skin Cancer

Keywords

Mohs micrographic surgery; Postoperative Pain; NSAID; Acetaminophen

Outcome Measures

Primary Outcomes (1)

• To evaluate the effect of the use of Meloxicam vs SoC on post-operative pain levels in participants undergoing Mohs micrographic surgery.

  Pain levels at specified times post-operation (POD 0 and POD 1) will be compared among the three treatment groups. This will be collected via the Numeric Pain Scale, a 0-10 scale using descriptives faces to assess pain by the patient.

  From enrollment to suture removal, wound check or flap takedown (7-21 days)

Study Arms (3)

Standard of Care (Acetaminophen/Ibuprofen)

ACTIVE COMPARATOR

This randomized control group will take a mandatory one-time dose of 500 mg acetaminophen with alternating 200 mg ibuprofen and 500 mg acetaminophen (standard of care) every 3 hours for pain.

Drug: Acetaminophen 500mg

Meloxicam 7.5 mg

EXPERIMENTAL

This randomly assigned experimental group will take a mandatory one-time dose of oral Meloxicam 7.5 mg with as-needed acetaminophen 500 mg every 3 hours. Administration of Meloxicam will be upon completion of Mohs closure.

Drug: Meloxicam 7.5 mg

Meloxicam 15 mg

EXPERIMENTAL

This randomly assigned experimental group will take a mandatory one-time dose of oral Meloxicam 15 mg with as-needed acetaminophen 500 mg every 3 hours. Administration of Meloxicam will be upon completion of Mohs closure.

Drug: Meloxicam 15 mg

Interventions

Meloxicam 7.5 mg DRUG

This intervention is the mandatory oral Meloxicam 7.5mg dose after Mohs closure.

Meloxicam 7.5 mg

Meloxicam 15 mg DRUG

This intervention is the mandatory oral Meloxicam 15mg dose after Mohs closure.

Meloxicam 15 mg

Acetaminophen 500mg DRUG

This randomized control group will take a mandatory one-time dose of 500 mg acetaminophen with alternating 200 mg ibuprofen and 500 mg acetaminophen (standard of care) every 3 hours for pain.

Standard of Care (Acetaminophen/Ibuprofen)

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult patients who consents to the study and are undergoing Mohs micrographic surgery at the University of Oklahoma.

You may not qualify if:

• Women who are pregnant, suspected to be pregnant, or planning to become pregnant during the study period will be excluded from participation.
• Chronic liver disease (chronic hepatitis, acute hepatitis, cirrhosis, NASH, NAFLD, alcoholic liver disease, hemochromatosis, Wilson's disease)
• Chronic kidney disease stage III or greater,
• Aspirin-sensitive asthma
• History of chronic NSAID use
• Patients vulnerable to drug interactions
• GI bleeds
• Peptic ulcers
• Non-English speakers

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Related Publications (7)

• Limthongkul B, Samie F, Humphreys TR. Assessment of postoperative pain after Mohs micrographic surgery. Dermatol Surg. 2013 Jun;39(6):857-63. doi: 10.1111/dsu.12166. Epub 2013 Mar 6.

  PMID: 23464845 BACKGROUND

• Benzon HT. Practical management of pain. 2014;

  BACKGROUND

• Evans T, Nicholas TA, Sutton AV, Wysong A. How We Do It: Postoperative Pain Control in Mohs Micrographic Surgery. Dermatol Surg. 2021 Feb 1;47(2):280-282. doi: 10.1097/DSS.0000000000002279. No abstract available.

  PMID: 31809346 BACKGROUND

• Sniezek PJ, Brodland DG, Zitelli JA. A randomized controlled trial comparing acetaminophen, acetaminophen and ibuprofen, and acetaminophen and codeine for postoperative pain relief after Mohs surgery and cutaneous reconstruction. Dermatol Surg. 2011 Jul;37(7):1007-13. doi: 10.1111/j.1524-4725.2011.02022.x. Epub 2011 May 11.

  PMID: 21561527 BACKGROUND

• Firoz BF, Goldberg LH, Arnon O, Mamelak AJ. An analysis of pain and analgesia after Mohs micrographic surgery. J Am Acad Dermatol. 2010 Jul;63(1):79-86. doi: 10.1016/j.jaad.2009.10.049.

  PMID: 20542176 BACKGROUND

• Saco M, Golda N. Optimal timing of postoperative pharmacologic pain control in Mohs micrographic surgery: A prospective cohort study. J Am Acad Dermatol. 2020 Feb;82(2):495-497. doi: 10.1016/j.jaad.2019.07.077. Epub 2019 Jul 30. No abstract available.

  PMID: 31374303 BACKGROUND

• Alam M, Ibrahim O, Nodzenski M, Strasswimmer JM, Jiang SI, Cohen JL, Albano BJ, Batra P, Behshad R, Benedetto AV, Chan CS, Chilukuri S, Crocker C, Crystal HW, Dhir A, Faulconer VA, Goldberg LH, Goodman C, Greenbaum SS, Hale EK, Hanke CW, Hruza GJ, Jacobson L, Jones J, Kimyai-Asadi A, Kouba D, Lahti J, Macias K, Miller SJ, Monk E, Nguyen TH, Oganesyan G, Pennie M, Pontius K, Posten W, Reichel JL, Rohrer TE, Rooney JA, Tran HT, Poon E, Bolotin D, Dubina M, Pace N, Kim N, Disphanurat W, Kathawalla U, Kakar R, West DP, Veledar E, Yoo S. Adverse events associated with mohs micrographic surgery: multicenter prospective cohort study of 20,821 cases at 23 centers. JAMA Dermatol. 2013 Dec;149(12):1378-85. doi: 10.1001/jamadermatol.2013.6255.

  PMID: 24080866 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Skin Neoplasms

Interventions

Meloxicam; Acetaminophen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Thiazines; Sulfur Compounds; Organic Chemicals; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Lindsey Collins, MD

  University of Oklahoma, Department of Dermatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chase Pitchford, MD

CONTACT

405-271-6110; chase-pitchford@ouhsc.edu

Landon Hendrickson, MD

CONTACT

405-271-6110; Landon-Hendrickson@ou.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Randomization will occur on which of the 3 groups each patient will be enrolled in, thus the investigators and participants will know which group they are in.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned to one of three groups, and each group receives a different intervention.

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: October 1, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): June 2, 2026
• Study Completion (Estimated): August 2, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)