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To compare suzetrigine versus hydrocodone/acetaminophen for postoperative pain control following dermatologic surgery.
This study is a randomized, controlled trial that is evaluating the safety and efficacy of suzetrigine as a postoperative pain medication compared to the standard of care Hydrocodone/Acetaminophen in patients undergoing Mohs micrographic surgery (MMS) who are at high-risk for postoperative pain and opioid use. The goal is to reduce opioid prescription use and give patients a non-opioid pain medication option for particularly painful surgeries. Patients will be randomized into one of two groups, one group will receive the interventional medication and the other the standard of care medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator | Participants will receive the standard of care drug Norco (a medicine that combines hydrocodone and acetaminophen). |
|
| Control | Active Comparator | Participants will receive the control drug, Suzetrigine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Norco 5Mg-325Mg Tablet | Drug | Standard of care drug |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in need for opioid medication for pain management after Mohs micrographic surgery | Change in mean visual analog scale (VAS; 0-10) pain scores at 24 and 48 hours after surgery with a minimal change in pain score of 1.0 points. | 48hours post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported adequacy of pain control | Assessment of pain control with use of medication following surgery. | 48hours post surgery |
| Rescue pain management use | Changes in need to use rescue medication for pain management |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stan Tolkachjov, MD | Baylor Medical University Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22959232 | Background | Ad Hoc Task Force; Connolly SM, Baker DR, Coldiron BM, Fazio MJ, Storrs PA, Vidimos AT, Zalla MJ, Brewer JD, Smith Begolka W; Ratings Panel; Berger TG, Bigby M, Bolognia JL, Brodland DG, Collins S, Cronin TA Jr, Dahl MV, Grant-Kels JM, Hanke CW, Hruza GJ, James WD, Lober CW, McBurney EI, Norton SA, Roenigk RK, Wheeland RG, Wisco OJ. AAD/ACMS/ASDSA/ASMS 2012 appropriate use criteria for Mohs micrographic surgery: a report of the American Academy of Dermatology, American College of Mohs Surgery, American Society for Dermatologic Surgery Association, and the American Society for Mohs Surgery. J Am Acad Dermatol. 2012 Oct;67(4):531-50. doi: 10.1016/j.jaad.2012.06.009. Epub 2012 Sep 5. | |
| Background | Phillips, Shay, et al. |
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| ID | Term |
|---|---|
| D012878 | Skin Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C514822 | oxycodone-acetaminophen |
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Participants are randomized into one of two group: interventional group and control group
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| Suzetrigine |
| Drug |
Control Drug |
|
| 48hours post surgery |
| Adverse Events | Evaluation of occurence of adverse events (irregular heart beat, abnormal blood pressure, change in consciousness, or need for urgent care or emergency room visit in the first 3 days after surgery). | 3 days after surgery |