Parotidectomy
Conditions
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.
Interventions
DRUGCelecoxib
200mg every 12 hours
DRUGTylenol
650mg q6h
DRUGOxycodone
5mg every 6 hours as needed
DRUGplacebo
every 12 hours
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of oxycodone pills taken | 7 days | Total number of oxycodone pills taken during the first 7 days post-operative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain scores | Baseline (post-operative) to 7 days | 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. |
| Side effects from medications | 7 days | Participants will self-report any side effects experienced from medications for the first 7 days post-operative |
| Drain duration | 7 days | Length of time participant retains the post-operative drain |
| Number of post-operative complications | 7 days | Participants will report any post-operative complications experienced during the first 7 days post-operative |
Countries
United States
Contacts
Primary ContactHayley Mann, MD
Outcome results
None listed