NCT06948513

Effect of Over-the-counter Analgesics on Postoperative Pain

Completed Phase 3 Last updated 29 April 2025

What this trial tests

Phase 3 trial testing Naproxen in Pain Management in 200 participants. Completed in 30 June 2023.

Timeline

22 December 2022

Primary endpoint
30 June 2023

30 June 2023

Quick facts

Lead sponsor	Zitelli & Brodland Skin Cancer Center
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	200
Start date	22 December 2022
Primary completion	30 June 2023
Estimated completion	30 June 2023
Sites	1 location across United States

Drugs / interventions tested

• Naproxen (naproxen) — full drug profile →
• Acetaminophen (Standard of Care) — full drug profile →
• ibuprofen (ibuprofen) — full drug profile →

Conditions studied

• Pain Management — all drugs for Pain Management →

Sponsor

Zitelli & Brodland Skin Cancer Center — full company profile →

Who can join

Eligibility, any sex, with Pain Management. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.