Meloxicam in Mohs Micrographic Surgery
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-110
SponsorUniversity of Oklahoma
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All adult patients who consents to the study and are undergoing Mohs micrographic surgery at the University of Oklahoma.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Meloxicam 7.5 mg
DrugThis intervention is the mandatory oral Meloxicam 7.5mg dose after Mohs closure.
Meloxicam 15 mg
DrugThis intervention is the mandatory oral Meloxicam 15mg dose after Mohs closure.
Acetaminophen 500mg
DrugThis 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.
Treatment groups
300 Participants
are divided into 3 treatment groupsGroup A: Standard of Care (Acetaminophen/Ibuprofen)Active comparator 1 intervention
Group B: Meloxicam 7.5 mgExperimental treatment 1 intervention
Group C: Meloxicam 15 mgExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
From enrollment to suture removal, wound check or flap takedown (7-21 days)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov