Celecoxib for ENT Pain Management

Phase 2RecruitingNCT06505187

University of Wisconsin, Madison84 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Parotidectomy

Interventions

CelecoxibDRUG

200mg every 12 hours

TylenolDRUG

650mg q6h

OxycodoneDRUG

5mg every 6 hours as needed

placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Wisconsin

Madison, Wisconsin, United States

RECRUITING

Outcomes

Primary Outcomes

Number of oxycodone pills taken

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

Time frame: 7 days

Secondary Outcomes

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.

Time frame: 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

Time frame: 7 days

Drain duration

Length of time participant retains the post-operative drain

Time frame: 7 days

Number of post-operative complications

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

Time frame: 7 days

Central Contacts

Hayley Mann, MD

CONTACT

480-272-4258 hmann3@wisc.edu

Data from ClinicalTrials.gov

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