AdenotonsillectomyPhase 1/2NCT07870447
Preoperative Celecoxib and Acetaminophen Versus Acetaminophen Alone for Pain Control After Pediatric Adenotonsillectomy
A Phase 1/2 study testing Celecoxib, Acetaminophen and Dexamethasone in people with Adenotonsillectomy and Postoperative Pain, run by NYU Langone Health at 1 site in United States.
Trial summary
This is an open-label randomized study of approximately 500 pediatric patients (2-18 years of age, weighing more than 10 kg) undergoing adenotonsillectomy. Participants are assigned to a preoperative multimodal analgesic regimen (oral celecoxib the evening before and the morning of surgery, plus intra-operative… Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Adenotonsillectomy, Postoperative Pain
- What is being tested?
- Celecoxib, Acetaminophen and Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 30 Dec 2029
- Phase
- Phase 1/2
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric patients 2-18 years of age
- Weighing greater than 10 kg
- Undergoing adenotonsillectomy
- English- or Spanish-speaking patients
Who cannot join
- Any adjunct procedure other than bilateral myringotomy tubes (BMT) or direct laryngoscopy and bronchoscopy (DLB) without bronchoalveolar lavage (BAL)
- Bleeding disorders
- Allergy to NSAIDs
- Allergy to acetaminophen (Tylenol)
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Open-Label, Randomized Study of Preoperative Celecoxib After Pediatric Adenotonsillectomy
This is an open-label randomized study of approximately 500 pediatric patients (2-18 years of age, weighing more than 10 kg) undergoing adenotonsillectomy. Participants are assigned to a preoperative multimodal analgesic regimen (oral celecoxib the evening before and the morning of surgery, plus intra-operative dexamethasone and acetaminophen) or to standard of care (no pre-operative medication; intra-operative dexamethasone and acetaminophen). The primary aim is to compare postoperative pain control, measured by rescue analgesic consumption, over the first 72 hours after surgery. Secondary aims assess safety (postoperative bleeding and adverse medication events) and feasibility (healthcare utilization and caregiver satisfaction).
Read the detailed description
This is an open-label, randomized, parallel-group study of a preoperative multimodal analgesic regimen versus standard-of-care no pre-operative analgesia in pediatric patients aged 2-18 years and weighing more than 10 kg who are undergoing adenotonsillectomy.
Multimodal arm: oral celecoxib (6 mg/kg, max 100 mg) the evening before surgery and the morning of surgery, plus intra-operative dexamethasone (Decadron) and acetaminophen (Tylenol). Standard-of-care arm: no pre-operative medication; intra-operative dexamethasone (Decadron) and acetaminophen (Tylenol). In both arms, the post-operative regimen is the attending's standard of care.
Approach: An open-label design reflects the real-world dosing burden on families and supports recruitment feasibility in this pediatric population. To mitigate potential bias, the primary outcome (analgesic rescue consumption) is an objective, chart-verified measure, and secondary subjective outcomes will be collected by study personnel blinded to treatment assignment.
Primary Aim (Superior Efficacy): To compare postoperative pain control between pre-operative celecoxib vs. no pre-operative medication in the first 72 hours after surgery. Outcomes: rescue analgesic use in the PACU and within 72 hours post-operatively (morphine equivalents PO/IV, time to rescue); PACU length of stay; PACU pain score (Wong-Baker (>5) vs. FACES (<5) Pain Rating Scale); a 72-hour patient/family pain diary including time to resumption of normal oral intake and activity.
Secondary Aim (Non-Inferior Safety): To compare the safety of the preoperative analgesic regimens according to postoperative bleeding rates and adverse medication events (e.g., nausea/vomiting, renal/GI effects). Outcomes: patient/family diary of medication adverse events from the day before surgery through post-operative day 3; and chart review of primary and secondary bleeding events, including whether they required a phone call, ED visit, admission, or intervention.
Secondary Aim (Feasibility): To assess healthcare utilization (ED visits, calls, readmission) and caregiver satisfaction. Outcomes: chart review of healthcare utilization (pre- or post-operative phone calls, Epic messages, ED visits, readmission); and, if the pre-operative evening medication was not given, the reason why not.
- Conditions
- Adenotonsillectomy, Postoperative Pain
- Being tested
- Celecoxib, Acetaminophen, Dexamethasone
- Keywords
- Celecoxib, Acetaminophen, Multimodal analgesia, Preoperative analgesia, Postoperative pain, Pediatric, Adenotonsillectomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelecoxibDrug
Oral celecoxib 6 mg/kg per dose (max 100 mg), given the evening before surgery and the morning of surgery
AcetaminophenDrug
Intra-operative acetaminophen (Tylenol)
DexamethasoneDrug
Intra-operative dexamethasone (Decadron)
| Study group | Role | What they receive |
|---|---|---|
| Pre-operative Celecoxib | Experimental | Pediatric patients (2-18 years, >10 kg) undergoing adenotonsillectomy who receive oral celecoxib (6 mg/kg, max 100 mg) the evening before surgery and the morning of surgery, plus intra-operative dexamethasone (Decadron) and acetaminophen (Tylenol). Post-operative regimen is the attending's standard of care. Receives: Drug: Celecoxib; Drug: Acetaminophen; Drug: Dexamethasone |
| No pre-operative medication | Active comparator | Pediatric patients (2-18 years, >10 kg) undergoing adenotonsillectomy who receive no pre-operative medication; intra-operative dexamethasone (Decadron) and acetaminophen (Tylenol) only. Post-operative regimen is the attending's standard of care. Receives: Drug: Acetaminophen; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rescue Analgesic Use in PACU
Chart-verified rescue analgesic consumption in the post-anesthesia care unit (PACU), expressed in morphine equivalents (PO/IV).
Measured: PACU Stay (PACU arrival to PACU discharge) - Approximately 3 Hours
Time to First Rescue Analgesic in PACU
Time to first chart-verified rescue analgesic consumption in the post-anesthesia care unit (PACU).
Measured: PACU Stay (PACU arrival to PACU discharge) - Approximately 3 Hours
Rescue Opioid Analgesic Use within 72 Hours Post-Op
Rescue opioid analgesic consumption, expressed in morphine equivalents (PO/IV), within 72 hours after surgery.
Measured: Up to Hour 72 Post-Operation
Time to First Rescue Opioid Analgesic Use within 72 Hours Post-Op
Time to first rescue escue opioid analgesic consumption within 72 hours after surgery.
Measured: Up to Hour 72 Post-Operation
Secondary outcomes (7)
PACU Length of Stay
Measured: PACU Stay (PACU arrival to PACU discharge) - Approximately 3 Hours
Post-Operative PACU Pain Score: Wong-Baker
Post-operative pain will be assessed in the PACU using the Wong-Baker FACES pain rating scale. The scale asks participants to rate their pain on a scale from 0-10, with higher scores representing greater pain.
Measured: PACU Stay (PACU arrival to PACU discharge) - Approximately 3 Hours
Return to normal diet
Time from surgery to resumption of normal oral intake, as recorded in patient/family diary.
Measured: Up to Hour 72 Post-Operation
Return to normal activity
Time from surgery to resumption of normal activity, as recorded in patient/family diary.
Measured: Up to Hour 72 Post-Operation
Medication adverse events
Adverse medication events (e.g., nausea/vomiting, renal/GI effects) recorded in the patient/family diary.
Measured: Up to Day 3 Post-Operation
Post-operative bleeding events
Primary and secondary bleeding events identified by chart review.
Measured: Up to Day 14 Post-Operation
Healthcare utilization
Proportion of participants with emergency visits, readmissions, MyChart messages, or pre- or post-operative phone calls.
Measured: Up to Day 30 Post-Operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Aug 2028 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AdenotonsillectomyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christina Yang, MD, Principal investigator, NYU Langone HealthZahrah Taufique, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870447
- Sponsor's protocol ID
- 26-00911
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Christina.Yang@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Publications
Shaffer AD, Omar M, Maguire RC, Dohar JE, Stapleton AL, Kitsko DJ, Tobey ABJ, Padia R, Simons JP, Whelan RL, Jabbour N, McCoy JL, Rushchak MV, Nguyen K, Hall-Burton DM, Chi DH. Postoperative Oral Dexamethasone and Pediatric Tonsillectomy Morbidity: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2026 Jul 23:e261910. doi: 10.1001/jamaoto.2026.1910. Online ahead of print.
PubMed 42490074
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized Study of Preoperative Celecoxib After Pediatric Adenotonsillectomy
- ClinicalTrials.gov ID
- NCT07870447
- Acronym / sponsor ID
- 26-00911
- Conditions
- Adenotonsillectomy, Postoperative Pain
- Keywords
- Celecoxib, Acetaminophen, Multimodal analgesia, Preoperative analgesia, Postoperative pain, Pediatric, Adenotonsillectomy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Aug 2028 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 13 Oct 2026 (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.
This is an open-label randomized study of approximately 500 pediatric patients (2-18 years of age, weighing more than 10 kg) undergoing adenotonsillectomy. Participants are assigned to a preoperative multimodal analgesic regimen (oral celecoxib the evening before and the morning of surgery, plus intra-operative dexamethasone and acetaminophen) or to standard of care (no pre-operative medication; intra-operative dexamethasone and acetaminophen). The primary aim is to compare postoperative pain control, measured by rescue analgesic consumption, over the first 72 hours after surgery. Secondary aims assess safety (postoperative bleeding and adverse medication events) and feasibility (healthcare utilization and caregiver satisfaction).
Detailed description
This is an open-label, randomized, parallel-group study of a preoperative multimodal analgesic regimen versus standard-of-care no pre-operative analgesia in pediatric patients aged 2-18 years and weighing more than 10 kg who are undergoing adenotonsillectomy.
Multimodal arm: oral celecoxib (6 mg/kg, max 100 mg) the evening before surgery and the morning of surgery, plus intra-operative dexamethasone (Decadron) and acetaminophen (Tylenol). Standard-of-care arm: no pre-operative medication; intra-operative dexamethasone (Decadron) and acetaminophen (Tylenol). In both arms, the post-operative regimen is the attending's standard of care.
Approach: An open-label design reflects the real-world dosing burden on families and supports recruitment feasibility in this pediatric population. To mitigate potential bias, the primary outcome (analgesic rescue consumption) is an objective, chart-verified measure, and secondary subjective outcomes will be collected by study personnel blinded to treatment assignment.
Primary Aim (Superior Efficacy): To compare postoperative pain control between pre-operative celecoxib vs. no pre-operative medication in the first 72 hours after surgery. Outcomes: rescue analgesic use in the PACU and within 72 hours post-operatively (morphine equivalents PO/IV, time to rescue); PACU length of stay; PACU pain score (Wong-Baker (>5) vs. FACES (<5) Pain Rating Scale); a 72-hour patient/family pain diary including time to resumption of normal oral intake and activity.
Secondary Aim (Non-Inferior Safety): To compare the safety of the preoperative analgesic regimens according to postoperative bleeding rates and adverse medication events (e.g., nausea/vomiting, renal/GI effects). Outcomes: patient/family diary of medication adverse events from the day before surgery through post-operative day 3; and chart review of primary and secondary bleeding events, including whether they required a phone call, ED visit, admission, or intervention.
Secondary Aim (Feasibility): To assess healthcare utilization (ED visits, calls, readmission) and caregiver satisfaction. Outcomes: chart review of healthcare utilization (pre- or post-operative phone calls, Epic messages, ED visits, readmission); and, if the pre-operative evening medication was not given, the reason why not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-operative Celecoxib | Experimental | Drug: Celecoxib, Drug: Acetaminophen, Drug: DexamethasonePediatric patients (2-18 years, >10 kg) undergoing adenotonsillectomy who receive oral celecoxib (6 mg/kg, max 100 mg) the evening before surgery and the morning of surgery, plus intra-operative dexamethasone (Decadron) and acetaminophen (Tylenol). Post-operative regimen is the attending's standard of care. |
| No pre-operative medication | Active comparator | Drug: Acetaminophen, Drug: DexamethasonePediatric patients (2-18 years, >10 kg) undergoing adenotonsillectomy who receive no pre-operative medication; intra-operative dexamethasone (Decadron) and acetaminophen (Tylenol) only. Post-operative regimen is the attending's standard of care. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Pediatric patients 2-18 years of age
- Weighing greater than 10 kg
- Undergoing adenotonsillectomy
- English- or Spanish-speaking patients
Key exclusion criteria (5 listed)
- Any adjunct procedure other than bilateral myringotomy tubes (BMT) or direct laryngoscopy and bronchoscopy (DLB) without bronchoalveolar lavage (BAL)
- Bleeding disorders
- Allergy to NSAIDs
- Allergy to acetaminophen (Tylenol)
- Pregnancy
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 |
|---|---|---|
| CelecoxibOral celecoxib 6 mg/kg per dose (max 100 mg), given the evening before surgery and the morning of surgery | Drug | Pre-operative Celecoxib |
| AcetaminophenIntra-operative acetaminophen (Tylenol) | Drug | No pre-operative medication, Pre-operative Celecoxib |
| DexamethasoneIntra-operative dexamethasone (Decadron) | Drug | No pre-operative medication, Pre-operative Celecoxib |
Primary outcome
Rescue Analgesic Use in PACU
Time frame: PACU Stay (PACU arrival to PACU discharge) - Approximately 3 Hours
Chart-verified rescue analgesic consumption in the post-anesthesia care unit (PACU), expressed in morphine equivalents (PO/IV).
Time to First Rescue Analgesic in PACU
Time frame: PACU Stay (PACU arrival to PACU discharge) - Approximately 3 Hours
Time to first chart-verified rescue analgesic consumption in the post-anesthesia care unit (PACU).
Rescue Opioid Analgesic Use within 72 Hours Post-Op
Time frame: Up to Hour 72 Post-Operation
Rescue opioid analgesic consumption, expressed in morphine equivalents (PO/IV), within 72 hours after surgery.
Time to First Rescue Opioid Analgesic Use within 72 Hours Post-Op
Time frame: Up to Hour 72 Post-Operation
Time to first rescue escue opioid analgesic consumption within 72 hours after surgery.
7 secondary outcomes
PACU Length of Stay
Time frame: PACU Stay (PACU arrival to PACU discharge) - Approximately 3 Hours
Post-Operative PACU Pain Score: Wong-Baker
Time frame: PACU Stay (PACU arrival to PACU discharge) - Approximately 3 Hours
Return to normal diet
Time frame: Up to Hour 72 Post-Operation
Return to normal activity
Time frame: Up to Hour 72 Post-Operation
Medication adverse events
Time frame: Up to Day 3 Post-Operation
Post-operative bleeding events
Time frame: Up to Day 14 Post-Operation
Healthcare utilization
Time frame: Up to Day 30 Post-Operation.
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 13 Oct 2026.
- Background: PubMed 42490074Shaffer AD, Omar M, Maguire RC, Dohar JE, Stapleton AL, Kitsko DJ, Tobey ABJ, Padia R, Simons JP, Whelan RL, Jabbour N, McCoy JL, Rushchak MV, Nguyen K, Hall-Burton DM, Chi DH. Postoperative Oral Dexamethasone and Pediatric Tonsillectomy Morbidity: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2026 Jul 23:e261910. doi: 10.1001/jamaoto.2026.1910. Online ahead of print.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Christina.Yang@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
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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.
Christina Yang, MD principal investigator
NYU Langone Health
Zahrah Taufique, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Celecoxib, Acetaminophen and Dexamethasone in people with Adenotonsillectomy and Postoperative Pain, run by NYU Langone Health 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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 13 Oct 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Zahrah Taufique, MD (646-501-7890, Zahrah.Taufique@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rescue Analgesic Use in PACU (time frame: PACU Stay (PACU arrival to PACU discharge) - Approximately 3 Hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07870447, which also lists 1 linked publication.
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 13 Oct 2026.