drugset / Trial / NCT04259333

Celecoxib vs. Acetaminophen/Codeine/Caffeine for Post-operative Analgesia in Rhinoplasty.

NCT04259333

Phase 4 Unknown 60 enrolled Blake Raggio University of Toronto · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

The primary aim of this study is to evaluate whether celecoxib (CELEBREX) is equivalent to acetaminophen-codeine-caffeine (TYLENOL# 3) for the management of pain after primary elective open septorhinoplasty with osteotomies. Secondary objectives include comparison of adverse medication effects and complications (e.g., bleeding events and bruising) that occur postoperatively. Half of the study participants will receive celecoxib, and half will receive acetaminophen-codeine-caffeine. We hypothesize that both interventions will exhibit no difference in pain control or postoperative bleeding, but that participants taking CELEBREX will experience less medication-related side effects and less bruising postoperatively.

Timeline

Start
2020-03-01
Primary completion
2020-12-01
Completion
2020-12-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acetaminophen Small molecule 300 mg Oral
Comparator Caffeine Small molecule 15 mg Oral
Subject Celecoxib Other / unclassified 200 mg Oral
Comparator Codeine Small molecule 30 mg Oral