Overview

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

Status:
Recruiting
Trial end date:
2020-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Blake Raggio
Humber River Hospital
Collaborator:
University of Toronto
Treatments:
Acetaminophen
Caffeine
Celecoxib
Codeine
Criteria
Inclusion Criteria:

- • Patients 18-80 years old undergoing elective primary open septorhinoplasty with
osteotomies by single surgeon, JA.

Exclusion Criteria:

- • Patients who undergo a rhinoplasty requiring a rib, ear, or temporalis fascia graft
(confounding variables for the level of pain experienced)

- Patients with a known history of chronic pain disorder, or who have
gastrointestinal bleeds, peptic ulcer disease or who have other comorbidities
that may prevent them from taking NSAIDs such as CELEBREX.

- Patients with a history of radiation, active head and neck malignancy or other
chronic pain disorders such as various rheumatologic diseases will be excluded to
decrease confounding factors in assessing pain.