ParotidectomyPhase 2NCT06505187
Celecoxib for ENT Pain Management
A Phase 2 study testing Celecoxib, Tylenol and Oxycodone in people with Parotidectomy, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parotidectomy
- What is being tested?
- Celecoxib, Tylenol and Oxycodone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2025to Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Wisconsin
Madison, Wisconsin, 53702
Hayley Mann, MD, 480-272-4258, hmann3@wisc.edu
About this study
Official title: Celecoxib Pain Management Following Superficial Parotidectomy: Opioid Sparing Protocol
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
Read the 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.
- Conditions
- Parotidectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
200mg every 12 hours
TylenolDrug
650mg q6h
OxycodoneDrug
5mg every 6 hours as needed
placeboDrug
every 12 hours
| Study group | Role | What they receive |
|---|---|---|
| Celecoxib for pain management | Experimental | Participants receive celecoxib in addition to Tylenol and oxycodone Receives: Drug: Celecoxib; Drug: Tylenol; Drug: Oxycodone |
| Placebo for pain management | Sham comparator | Participants receive placebo in addition to Tylenol and oxycodone Receives: Drug: Tylenol; Drug: Oxycodone; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of oxycodone pills taken
Total number of oxycodone pills taken during the first 7 days post-operative
Measured: 7 days
Secondary outcomes (4)
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.
Measured: 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
Measured: 7 days
Drain duration
Length of time participant retains the post-operative drain
Measured: 7 days
Number of post-operative complications
Participants will report any post-operative complications experienced during the first 7 days post-operative
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start28 Feb 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParotidectomyStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tiffany Glazer, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505187
- Sponsor's protocol ID
- 2023-1527
- Other IDs
- A539770, Protocol Version 7/5/24
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2024
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Celecoxib Pain Management Following Superficial Parotidectomy: Opioid Sparing Protocol
- ClinicalTrials.gov ID
- NCT06505187
- Acronym / sponsor ID
- 2023-1527
- Conditions
- Parotidectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Celecoxib for pain management | Experimental | Drug: Celecoxib, Drug: Tylenol, Drug: OxycodoneParticipants receive celecoxib in addition to Tylenol and oxycodone |
| Placebo for pain management | Sham comparator | Drug: Tylenol, Drug: Oxycodone, Drug: placeboParticipants receive placebo in addition to Tylenol and oxycodone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Celecoxib200mg every 12 hours | Drug | Celecoxib for pain management |
| Tylenol650mg q6h | Drug | Celecoxib for pain management, Placebo for pain management |
| Oxycodone5mg every 6 hours as needed | Drug | Celecoxib for pain management, Placebo for pain management |
| placeboevery 12 hours | Drug | Placebo for pain management |
Primary outcome
Number of oxycodone pills taken
Time frame: 7 days
Total number of oxycodone pills taken during the first 7 days post-operative
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Parotidectomy
RecruitingEarly Phase 1
Clinical Tolerance of an Intraparotid Injection of Bupivacaine, Combined With Dexamethasone, After Parotidectomy for Benign Tumor
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Swedish National Parotidectomy Study (SNaPs): Drainless Versus Standard Surgery
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Active, not recruiting
Endoscopic Versus Conventional Parotidectomy for Benign Parotid Tumors
Parotidectomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tiffany Glazer, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Celecoxib, Tylenol and Oxycodone in people with Parotidectomy, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hayley Mann, MD (480-272-4258, hmann3@wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of oxycodone pills taken (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.