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

NCT04259333 | Unknown Phase 4 FDA Drug

• 1 other identifier: 16511
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

opioid; rhinoplasty; pain, postoperative; celecoxib

Outcome Measures

Primary Outcomes (1)

• Pain Severity

  Difference in daily mean pain intensity based on Numeric Rating Scale (NRS). The NRS is composed of 0 (no pain at all) to 10 (worst imaginable pain).

  until the time of cast removal (up to 8 days postoperatively)

Secondary Outcomes (3)

• Medication-related side effects

  for side effects experienced up to the day of cast removal (up to 8 days postoperatively)

• Complications postoperatively

  for complications experienced up to the day of cast removal (up to 8 days postoperatively)

• Bruising

  day 6-8. depending on day of cast removal

Study Arms (2)

Test Arm

EXPERIMENTAL

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

Drug: Celecoxib 200mg

Control Arm

ACTIVE COMPARATOR

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

Drug: Acetaminophen, Codeine Drug Combination

Interventions

Celecoxib 200mg DRUG

Celecoxib tablet

Also known as: celebrex

Test Arm

Acetaminophen, Codeine Drug Combination DRUG

acetaminophen-codeine-caffeine tablet

Also known as: tylenol #3

Control Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Blake Raggio: lead
• University of Toronto: collaborator

Study Sites (1)

FACE Toronto

Toronto, Ontario, M4Y 0A2, Canada

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Celecoxib; acetaminophen, codeine drug combination; Acetaminophen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Aniline Compounds; Amines

Study Officials

• Jamil Asaria, MD

  University of Toronto | FACE Cosmetic Surgery Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Blake S Raggio, MD

CONTACT

504-235-3994; blakeraggio@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The surgeon (Care provider) performing all of the septorhinoplasty procedures will be blinded as to which pain medication the patients will receive postoperatively. The outcomes assessor evaluating the severity of bruising (using postoperative photographs taken on day of cast removal) will be blinded as to which pain medication the patient received
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Fellow

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: February 6, 2020
• Study Start: March 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: August 4, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available within 6 months of study completion
• Access Criteria: Data access requests will be reviewed by an external Independent Review Panel. Requests will be required to sign a Data Access Agreement

Locations

CA (1)