Celecoxib for ENT Pain Management

Celecoxib Pain Management Following Superficial Parotidectomy: Opioid Sparing Protocol

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

Study Overview

• Status: Recruiting
• Conditions: Parotidectomy
• Intervention / Treatment: Drug: Celecoxib; Drug: Tylenol; Drug: Oxycodone; Drug: placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Hayley Mann, MD; Phone Number: 480-272-4258; Email: hmann3@wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53702
      • Recruiting
      • University of Wisconsin
      • Contact: Hayley Mann, MD; Phone Number: 480-272-4258; Email: hmann3@wisc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Celecoxib for pain management; Participants receive celecoxib in addition to Tylenol and oxycodone	Drug: Celecoxib; 200mg every 12 hours; Drug: Tylenol; 650mg q6h; Drug: Oxycodone; 5mg every 6 hours as needed
Sham Comparator: Placebo for pain management; Participants receive placebo in addition to Tylenol and oxycodone	Drug: Tylenol; 650mg q6h; Drug: Oxycodone; 5mg every 6 hours as needed; Drug: placebo; every 12 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of oxycodone pills taken	Total number of oxycodone pills taken during the first 7 days post-operative	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain scores	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.	Baseline (post-operative) to 7 days
Side effects from medications	Participants will self-report any side effects experienced from medications for the first 7 days post-operative	7 days
Drain duration	Length of time participant retains the post-operative drain	7 days
Number of post-operative complications	Participants will report any post-operative complications experienced during the first 7 days post-operative	7 days

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Tiffany Glazer, MD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: July 10, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Azoles; Hydrocarbons; Hydrocarbons, Cyclic; Alkaloids; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Benzene Derivatives; Heterocyclic Compounds, 4 or More Rings; Benzenesulfonamides; Sulfonamides; Sulfones; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Morphine Derivatives; Pyrazoles; Codeine; Celecoxib; Acetaminophen; Oxycodone
• Other Study ID Numbers: 2023-1527; A539770 (Other Identifier: UW Madison); Protocol Version 7/5/24 (Other Identifier: UW- Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No