Clinical trial NCT06505187: Celecoxib for ENT Pain Management
Official title: Celecoxib Pain Management Following Superficial Parotidectomy: Opioid Sparing Protocol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Parotidectomy
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Number of oxycodone pills taken
timeFrame: 7 days
Secondary outcomes:
measure: Change in pain scores
timeFrame: Baseline (post-operative) to 7 days
measure: Side effects from medications
timeFrame: 7 days
measure: Drain duration
timeFrame: 7 days
measure: Number of post-operative complications
timeFrame: 7 days
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Tiffany Glazer, MD
role: PRINCIPAL_INVESTIGATOR
References: