Celecoxib for ENT Pain Management | NCT06505187

Studies
Celecoxib for ENT Pain Management

NCT06505187

Sponsor

University of Wisconsin, Madison

Status

Recruiting

Last Update Posted

Dec 3, 2025Actual

Enrollment

84Estimated

Phase

Phase 2

Conditions

Parotidectomy

Interventions

Celecoxib
Tylenol
Oxycodone
placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
A539770	Other Identifier	UW- Madison
Protocol Version 7/5/24	Other Identifier	UW- Madison

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 28, 2025Actual

Primary Completion Date

Sep 2026Estimated

Completion Date

Sep 2026Estimated

First Submitted Date

Jul 10, 2024

First Submission Date that Met QC Criteria

Jul 10, 2024

First Posted Date

Jul 17, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2025

Last Update Posted Date

Dec 3, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

84Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Celecoxib for pain management	Experimental	Participants receive celecoxib in addition to Tylenol and oxycodone	Drug: Celecoxib Drug: Tylenol Drug: Oxycodone
Placebo for pain management	Sham Comparator	Participants receive placebo in addition to Tylenol and oxycodone	Drug: Tylenol Drug: Oxycodone Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Celecoxib	Drug	200mg every 12 hours	Celecoxib for pain management

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hayley Mann, MD	Contact	480-272-4258		hmann3@wisc.edu

Overall Officials

Name	Affiliation	Role
Tiffany Glazer, MD	University of Wisconsin, Madison	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Wisconsin	Recruiting	Madison	Wisconsin	53702	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068579	Celecoxib
D000082	Acetaminophen
D010098	Oxycodone

Ancestor Terms

ID	Term
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals

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Browse Branches

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