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NCT Number: NCT06505187

Celecoxib for ENT Pain Management

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

Recruiting

Interested in participating?

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Wisconsin

Madison, Wisconsin, 53702, United States

Location status: Recruiting

Location contact

Hayley Mann, MD

CONTACT

[email protected]

480-272-4258

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Celecoxib

Drug

200mg every 12 hours

Tylenol

Drug

650mg q6h

Oxycodone

Drug

5mg every 6 hours as needed

Placebo

Drug

every 12 hours

Primary outcomes

  1. Number of oxycodone pills taken

    Time frame: 7 days

    Total number of oxycodone pills taken during the first 7 days post-operative

Secondary outcomes

  1. Change in pain scores

    Time frame: Baseline (post-operative) to 7 days

    Numerical pain scores will be measured using a post-operative modified brief pain inventory. Participants will rate their pain on a scale of 0-10, where 0 = no pain and 10 = worst pain.

  2. Side effects from medications

    Time frame: 7 days

    Participants will self-report any side effects experienced from medications for the first 7 days post-operative

  3. Drain duration

    Time frame: 7 days

    Length of time participant retains the post-operative drain

  4. Number of post-operative complications

    Time frame: 7 days

    Participants will report any post-operative complications experienced during the first 7 days post-operative

Study contacts

Contact information is provided by the study sponsor or research team.

Hayley Mann, MD

CONTACT

[email protected]

480-272-4258

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

Celecoxib Pain Management Following Superficial Parotidectomy: Opioid Sparing Protocol

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 17, 2024
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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