Celecoxib for ENT Pain Management
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Celecoxib, Tylenol, Oxycodone, placebo.
- Who it may be relevant to
- Registry conditions: Parotidectomy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Celecoxib Pain Management Following Superficial Parotidectomy: Opioid Sparing Protocol
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
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.
Interventions
- Drug Celecoxib
200mg every 12 hours - Drug Tylenol
650mg q6h - Drug Oxycodone
5mg every 6 hours as needed - Drug placebo
every 12 hours
Primary outcome measures
- Number of oxycodone pills taken [Time frame: 7 days]
Secondary outcome measures (4)
- Change in pain scores [Time frame: Baseline (post-operative) to 7 days]
- Side effects from medications [Time frame: 7 days]
- Drain duration [Time frame: 7 days]
- Number of post-operative complications [Time frame: 7 days]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University of Wisconsin — Madison
Identifiers
NCT: NCT06505187 · 2023-1527 · A539770 · Protocol Version 7/5/24