RecruitingPhase 2NCT06505187

Celecoxib for ENT Pain Management

Celecoxib Pain Management Following Superficial Parotidectomy: Opioid Sparing Protocol


Sponsor

University of Wisconsin, Madison

Enrollment

84 participants

Start Date

Feb 28, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria6

  • 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.

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Interventions

DRUGCelecoxib

200mg every 12 hours

DRUGTylenol

650mg q6h

DRUGOxycodone

5mg every 6 hours as needed

DRUGplacebo

every 12 hours


Locations(1)

University of Wisconsin

Madison, Wisconsin, United States

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NCT06505187


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