Celecoxib for ENT Pain Management

NCT ID: NCT06505187

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2026-09-30

Brief Summary

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

Detailed 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.

Conditions

Parotidectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Celecoxib for pain management

Participants receive celecoxib in addition to Tylenol and oxycodone

Group Type: EXPERIMENTAL

Celecoxib

Intervention Type: DRUG

200mg every 12 hours

Tylenol

Intervention Type: DRUG

650mg q6h

Oxycodone

Intervention Type: DRUG

5mg every 6 hours as needed

Placebo for pain management

Participants receive placebo in addition to Tylenol and oxycodone

Group Type: SHAM_COMPARATOR

Tylenol

Intervention Type: DRUG

650mg q6h

Oxycodone

Intervention Type: DRUG

5mg every 6 hours as needed

placebo

Intervention Type: DRUG

every 12 hours

Interventions

Celecoxib

200mg every 12 hours

Intervention Type: DRUG

Tylenol

650mg q6h

Intervention Type: DRUG

Oxycodone

5mg every 6 hours as needed

Intervention Type: DRUG

placebo

every 12 hours

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tiffany Glazer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin

Madison, Wisconsin, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Hayley Mann, MD

Role: CONTACT

hmann3@wisc.edu

480-272-4258

Facility Contacts

Hayley Mann, MD

Role: primary

hmann3@wisc.edu

480-272-4258

Other Identifiers

A539770

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 7/5/24

Identifier Type: OTHER

Identifier Source: secondary_id

2023-1527

Identifier Type: -

Identifier Source: org_study_id