Recruiting
Phase 2

Celecoxib

Sponsor:

University of Wisconsin, Madison

Code:

NCT06505187

Conditions

Parotidectomy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Celecoxib

Tylenol

Oxycodone

placebo

Study Details

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

Conditions

Parotidectomy

Study ID

NCT06505187

Start date

Feb 28, 2025

Status verified date

Jul, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

84 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Celecoxib for pain management

Participants receive celecoxib in addition to Tylenol and oxycodone

sham comparator: Placebo for pain management

Participants receive placebo in addition to Tylenol and oxycodone

Interventions

Celecoxib

200mg every 12 hours

Tylenol

650mg q6h

Oxycodone

5mg every 6 hours as needed

placebo

every 12 hours

Primary outcome measure

  • Number of oxycodone pills taken [ Time Frame: 7 days ]

Central Contacts and Locations

Central contacts

Hayley Mann, MD

480-272-4258hmann3@wisc.edu

Locations

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53702

Contacts

Hayley Mann, MD

480-272-4258hmann3@wisc.edu

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-07-29.