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Effect of Over-the-counter Analgesics on Postoperative Pain

NCT06948513 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-04-29

No results posted yet for this study

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

Interventions

DRUG

Naproxen

Naproxen given immediately post-operatively following Mohs surgery reconstruction

DRUG

Acetaminophen (Standard of Care)

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

DRUG

ibuprofen

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

Sponsors & Collaborators

  • Zitelli & Brodland Skin Cancer Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-22
Primary Completion
2023-06-30
Completion
2023-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06948513 on ClinicalTrials.gov