Effect of Over-the-counter Analgesics on Postoperative Pain

NCT06948513 | Completed Phase 3 FDA Drug

• 1 other identifier: 1344913
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain Management

Outcome Measures

Primary Outcomes (1)

• Patient reported pain score

  Recorded using a visual analog scale and taken at defined time intervals during postoperative period

  10 hours

Secondary Outcomes (1)

• Additional pain medication used

  10 hours

Study Arms (2)

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

Drug: Naproxen; Drug: Acetaminophen (Standard of Care)

Control

ACTIVE COMPARATOR

These patients received 'standard of care' use of ibuprofen in combination with acetaminophen in a patient directed manner for pain control

Drug: Acetaminophen (Standard of Care); Drug: ibuprofen

Interventions

Naproxen DRUG

Naproxen given immediately post-operatively following Mohs surgery reconstruction

Naproxen

Acetaminophen (Standard of Care) DRUG

Acetaminophen alternated with ibuprofen on an as needed, patient directed basis

Control; Naproxen

ibuprofen DRUG

Ibuprofen alternated with acetaminophen in a patient directed manner for as needed pain control

Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing Mohs micrographic surgery with same-day reconstruction on the head/neck

You may not qualify if:

• Second intention wound healing Operative site not on head and neck Self-described allergies to acetaminophen or any non-steroidal anti-inflammatory medication Pre-existing pain condition requiring analgesics History of bleeding or clotting disorder Recent history of upper gastrointestinal bleeding or ulcers Advanced liver disease or renal impairment Pregnancy Current use of anticoagulant (examples: aspirin, clopidogrel, warfarin, apixaban)

Sponsors & Collaborators

• Zitelli & Brodland Skin Cancer Center: lead

Study Sites (1)

Zitelli & Brodland Skin Cancer Center

Clairton, Pennsylvania, 15025, United States

Location

Related Publications (2)

• 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.

  PMID: 34850186 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

MeSH Terms

Conditions

Agnosia

Interventions

Naproxen; Acetaminophen; Standard of Care; Ibuprofen

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: April 29, 2025
• Study Start: December 22, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)