Recruiting

Celecoxib & Acetaminophen-Codeine-Caffeine

Sponsor:

Blake Raggio

Code:

NCT04259333

Conditions

Pain, Postoperative

Surgery--Complications

Opioid Analgesic Adverse Reaction

Opioid Use

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Celecoxib 200mg

Acetaminophen, Codeine Drug Combination

Study Details

Brief 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

Study ID

NCT04259333

Start date

Mar 1, 2020

Status verified date

Aug, 2020

Completion date

Dec 1, 2020

Anticipated

Primary completion date

Dec 1, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Test Arm

celecoxib 200 mg tablet by mouth every 12 hours for 7 days postoperatively prn pain

active comparator: Control Arm

codeine 30mg-acetaminophen 300mg-caffeine 15 mg tabelt by mouth every 4 hours for 7 days postoperatively prn pain

Interventions

Celecoxib 200mg

Celecoxib tablet

Acetaminophen, Codeine Drug Combination

acetaminophen-codeine-caffeine tablet

Primary outcome measure

  • Pain Severity [ Time Frame: until the time of cast removal (up to 8 days postoperatively) ]

Central Contacts and Locations

Central contacts

Blake S Raggio, MD

504-235-3994blakeraggio@gmail.com

Locations

FACE Toronto

Recruiting

Toronto, Ontario, Canada, M4Y 0A2

Contacts

Blake Raggio, MD

5042353994blakeraggio@gmail.com

More Information

Sponsor

Blake Raggio

Last update posted

Aug 4, 2020

Last verified

Aug, 2020

Keywords

  • opioid
  • rhinoplasty
  • pain, postoperative
  • celecoxib

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Blake Raggio on 2020-08-04.