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In 2011, a randomized controlled trial compared acetaminophen, acetaminophen + ibuprofen, and acetaminophen + codeine for post-operative pain relief after Mohs surgery. In this study, the combination of acetaminophen + ibuprofen was shown to be superior to the other treatment groups at controlling postoperative pain. The study also detailed the timing at which patients experienced pain after cutaneous reconstruction, with peak pain scores occurring at 4 hours post-op for all three groups. Since its publication, the as needed dosage of acetaminophen alternated with ibuprofen has become the standard of care for most patients undergoing cutaneous reconstructive surgery. Additionally, studies from multiple disciplines including cutaneous surgery, emergency medicine, otolaryngology and obstetrics have found that use of non-steroidal anti-inflammatories pose no greater incidence of side effects.
Given that peak pain levels occur approximately four hours after cutaneous reconstruction, likely due to the cessation of lidocaine or other local numbing medications, patients may benefit from additional pain relief during this critical time period. However, it is standard practice to start acetaminophen and ibuprofen only as needed when pain begins. Further, given the short half-life of ibuprofen (2 hours), it is unlikely that this medication taken in the immediate postoperative period would be of benefit at the four hour time mark. Therefore, we theorize that the one-time dosage of a long-acting non-steroidal anti-inflammatory taken upon completion of cutaneous surgery may be superior to the as needed dosing of acetaminophen and ibuprofen.
Upon completion of informed consent, enrolled participants will be randomized to one of two treatment groups.
Group 1 (intervention group): will receive a one-time, mandatory dose of Naproxen sodium 440 mg immediately following completion of cutaneous reconstruction. For a period of 24 hours after surgery, patients will then be instructed to use acetaminophen as needed per manufacturer instructions not to exceed 4 g in a 24 hour period. Patients will not be permitted to use additional nonsteroidal analgesics during the 24 hour period. Patients will be asked to record pain scales in a pain diary at time points 0, 2, 4, 6, 8, 10 and 24 hours after surgery as well as the amount and timing of breakthrough pain medication (acetaminophen). Patients will be contacted the day following their procedure by the Principal Investigator and their responses will be recorded. Upon recording of the patient's pain diary, their enrollment in the study is complete.
Group 2 (control group): will not receive any mandatory dose of postoperative analgesic. As is considered standard of care, these patients will be instructed to alternate use of ibuprofen and acetaminophen on an as needed basis per manufacturer instructions. The dose of acetaminophen is not to exceed 4 g in a 24 hour period. The dose of ibuprofen is not to exceed 1200 mg in a 24 hour period. Patients will be asked to record pain scales in a pain diary at time points 0, 2, 4, 6, 8, 10 and 24 hours after surgery as well as the amount and timing of breakthrough pain medication (acetaminophen or ibuprofen). Patients will be contacted the day following their procedure by the Principal Investigator and their responses will be recorded. Upon recording of the patient's pain diary, their enrollment in the study is complete.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naproxen | Experimental | These patients receive a one-time dose of naproxen at surgery completion. They are instructed to take acetaminophen as needed for additional pain |
|
| Control | Active Comparator | These patients received 'standard of care' use of ibuprofen in combination with acetaminophen in a patient directed manner for pain control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naproxen | Drug | Naproxen given immediately post-operatively following Mohs surgery reconstruction |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient reported pain score | Recorded using a visual analog scale and taken at defined time intervals during postoperative period | 10 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Additional pain medication used | Amount of as-needed dosing taken by patients for pain control | 10 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zitelli & Brodland Skin Cancer Center | Clairton | Pennsylvania | 15025 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34850186 | Background | Watson H, Hildebolt C, Rowland K. Pain Relief with Combination Acetaminophen/Codeine or Ibuprofen following Third-Molar Extraction: A Systematic Review and Meta-Analysis. Pain Med. 2022 May 30;23(6):1176-1185. doi: 10.1093/pm/pnab334. | |
| 21561527 | 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. |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D009288 | Naproxen |
| D000082 | Acetaminophen |
| D059039 | Standard of Care |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Acetaminophen (Standard of Care) | Drug | Acetaminophen alternated with ibuprofen on an as needed, patient directed basis |
|
| ibuprofen | Drug | Ibuprofen alternated with acetaminophen in a patient directed manner for as needed pain control |
|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |