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

NCT04259333 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-08-04

No results posted yet for this study

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.

Conditions

  • Pain, Postoperative
  • Surgery--Complications
  • Opioid Analgesic Adverse Reaction
  • Opioid Use

Interventions

DRUG

Celecoxib 200mg

Celecoxib tablet

DRUG

Acetaminophen, Codeine Drug Combination

acetaminophen-codeine-caffeine tablet

Sponsors & Collaborators

  • University of Toronto

    collaborator OTHER

  • Blake Raggio

    lead OTHER

Principal Investigators

  • Jamil Asaria, MD · University of Toronto | FACE Cosmetic Surgery Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2020-12-01
Completion
2020-12-01
FDA Drug
Yes

Countries

  • Canada

Study Locations

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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 NCT04259333 on ClinicalTrials.gov