Celecoxib for ENT Pain Management

University of Wisconsin (UW)

Status and phase: Enrolling; Phase 2

Conditions: Parotidectomy

Treatments: Drug: Oxycodone; Drug: Celecoxib; Drug: Tylenol; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06505187

2023-1527

Protocol Version 7/5/24 (Other Identifier)

A539770 (Other Identifier)

Details and patient eligibility

About

The goal of this clinical trial is to find out whether pain can be managed after an operation with celecoxib instead of oxycodone. The main question it aims to answer is if use of celecoxib plus Tylenol reduces the need for oxycodone.

Researchers will compare the combination of celecoxib and Tylenol to a placebo to find out whether celecoxib works to manage pain.

Participants will:

• Take celecoxib, or a placebo, plus Tylenol with opioids as needed
• Keep a diary of their pain between visits
• Complete questionnaires

Full description

Surgeons have a unique opportunity to reduce opioid prescriptions - and therefore potential opioid dependence, morbidity and mortality - by altering prescribing patterns in the perioperative period. This study aims to determine if celecoxib is a viable alternative for acute pain control in the postoperative setting for head and neck surgeries which could significantly reduce the amount of narcotic pain pills in circulation and can be extrapolated to other otolaryngologic procedures.

Enrollment: 84 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ability to understand and the willingness to sign a written informed consent document
• Willing to comply with all study procedures and be available for the duration of the study
• Ability to take oral medication
• Undergoing superficial parotidectomy
• Individuals at least 18 years of age
• Adequate organ function as indicated by standard laboratory tests: hematology (complete blood count), clinical chemistry

Exclusion criteria

• History of NSAIDs contraindication (severe congestive heart failure, CABG within 14 days, arrhythmias, significant coronary artery disease, cardiomyopathy, severe hepatic impairment, history of peptic ulcer disease or GI bleeding, use of anticoagulation (other than prophylactic aspirin)
• History of uncontrolled hypertension, cerebrovascular accident, sulfa allergy, allergy to celecoxib
• Concurrent use of CYP2C9 potentiator/inhibitor
• Use of investigational drugs, biologics, or devices within 30 days prior to randomization.
• Individuals who are pregnant, lactating or planning on becoming pregnant during the study.
• Not suitable for study participation due to other reasons at the discretion of the investigators.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 2 patient groups

Celecoxib for pain management

Experimental group

Description:

Participants receive celecoxib in addition to Tylenol and oxycodone

Treatment:

Drug: Tylenol

Drug: Celecoxib

Drug: Oxycodone

Placebo for pain management

Sham Comparator group

Description:

Participants receive placebo in addition to Tylenol and oxycodone

Treatment:

Drug: placebo

Drug: Tylenol

Drug: Oxycodone