Meloxicam for Surgical Pain

Overseen By Landon Hendrickson, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Oklahoma

Must not be taking: Chronic NSAIDs

Disqualifiers: Pregnancy, Liver disease, Kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks better ways to manage pain after Mohs micrographic surgery, a procedure for skin cancer. Researchers compare different doses of Meloxicam, a non-steroidal anti-inflammatory drug (NSAID), with common painkillers like ibuprofen and acetaminophen to determine which option offers the best pain relief and patient satisfaction. Participants will complete pain and satisfaction surveys to identify the most effective treatment. Individuals undergoing Mohs surgery at the University of Oklahoma, who do not have certain health issues like liver or kidney disease, may qualify. As a Phase 4 trial, this research focuses on understanding how an already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop your current medications. However, if you have a history of chronic NSAID use or are vulnerable to drug interactions, you may not be eligible to participate.

What is the safety track record for these treatments?

Previous studies have found meloxicam to be a safe option for managing post-surgical pain. As a non-steroidal anti-inflammatory drug (NSAID), it targets a specific enzyme involved in inflammation, making it gentler on the stomach compared to other NSAIDs. Research has shown that meloxicam, whether administered by IV or in pill form, is generally well-tolerated. Most patients using meloxicam for post-surgical pain experience fewer side effects and often require less additional pain medication, such as opioids.

This trial tests meloxicam in two doses: 7.5 mg and 15 mg. Although these exact doses aren't directly mentioned in previous studies, similar doses have demonstrated good safety in other contexts. This suggests that meloxicam could be a reliable choice for controlling pain after Mohs surgery, especially since it is already approved for other pain-related uses. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Meloxicam for surgical pain because it offers a promising alternative to standard painkillers like acetaminophen and ibuprofen. Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) that has a unique ability to selectively inhibit the COX-2 enzyme, which can lead to fewer gastrointestinal side effects compared to other NSAIDs. The trial is exploring two doses: 7.5 mg and 15 mg, potentially allowing for more tailored pain management. This could enhance patient comfort post-surgery, especially for those who experience issues with current pain management options.

What evidence suggests that this trial's treatments could be effective for surgical pain?

Research shows that meloxicam effectively manages post-surgery pain. Studies have found that administering a 30 mg dose of meloxicam through an IV can significantly reduce pain and decrease the need for opioids after surgery. Although most research has focused on IV meloxicam, these findings suggest that meloxicam is a potent pain reliever. Patients have reported high satisfaction with their pain control when using meloxicam. In this trial, participants will receive either a 7.5 mg or 15 mg dose of oral meloxicam, which might effectively relieve pain in surgeries like Mohs surgery. ^{1 2 5 6 7}

Who Is on the Research Team?

Lindsey Collins, MD

Principal Investigator

University of Oklahoma, Department of Dermatology

Are You a Good Fit for This Trial?

This trial is for individuals undergoing Mohs micrographic surgery, seeking alternatives for postoperative pain control. Participants should be suitable candidates for NSAID use and willing to complete surveys about their pain and satisfaction.

Inclusion Criteria

I am an adult who agreed to participate and am having Mohs surgery at the University of Oklahoma.

Exclusion Criteria

Aspirin-sensitive asthma

Non-English speakers

I am at risk for drug interactions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single dose of Meloxicam or standard care medication post-Mohs surgery, followed by as-needed acetaminophen

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain levels and patient satisfaction post-surgery

7-21 days

1-2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Meloxicam

Trial Overview The study tests the effectiveness of Meloxicam (7.5 mg or 15 mg) combined with Acetaminophen (500 mg), compared to a regimen of Acetaminophen and Ibuprofen in managing post-surgery pain after Mohs surgery.

How Is the Trial Designed?

Group I: Meloxicam 7.5 mg Experimental Treatment 1 Intervention

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.

Group II: Meloxicam 15 mg Experimental Treatment 1 Intervention

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.

Group III: Standard of Care (Acetaminophen/Ibuprofen) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6360894/

Meloxicam in the management of post-operative pain Clinical trials suggest that single IV doses of 30 mg meloxicam significantly reduce post-operative pain as well as opioid requirements. We conclude that ...

2. dig.pharmacy.uic.edu dig.pharmacy.uic.edu/faqs/2020-2/august-2020-faqs/are-there-data-to-support-the-use-of-IV-meloxicam-for-perioperative-pain-control-in-orthopedic-surgery-patients/

Are there data to support the use of IV meloxicam for ... Overall, IV meloxicam at doses of 30 and 60 mg appears to be a safe and effective for moderate-to-severe pain post orthopedic surgery.

3. academic.oup.com academic.oup.com/painmedicine/article/22/6/1261/6121313

Safety and Efficacy of Perioperative Intravenous Meloxicam for ... Meloxicam IV was associated with less opioid use versus placebo during the 24 hours after surgery (18.9 ± 1.32 vs 27.7 ± 1.37 mg IV morphine ...

4. journals.lww.com journals.lww.com/md-journal/fulltext/2019/10040/early_preoperative_versus_postoperative.11.aspx

Early preoperative versus postoperative administration of... Thus, we conducted this study and observed that EPA of meloxicam reduced pain more effectively within 12 hours but had similar effects on pain relief after 12 ...

5. tandfonline.com tandfonline.com/doi/full/10.2217/pmt-2020-0061

A Phase IIIB Randomized Clinical Trial in 55 Patients ... Most subjects (>92%) were satisfied with postoperative pain medication. Conclusion: Meloxicam IV was generally well tolerated and associated with decreased ...

6. journals.lww.com journals.lww.com/anesthesia-analgesia/fulltext/2019/06000/analgesic_efficacy_and_safety_of_intravenous.44.aspx

Analgesic Efficacy and Safety of Intravenous Meloxicam in... A meloxicam IV dose of 5–60 mg was generally well tolerated and appeared to reduce opioid consumption in subjects with moderate-to-severe pain after open ...

7. rapm.bmj.com rapm.bmj.com/content/44/3/360

a pooled analysis of safety and opioid-reducing effects The pooled safety data from the phase II/III clinical program demonstrate thatintravenous meloxicam was generally well tolerated in subjects with moderate to ...