A Phase 1/2 interventional study of Celecoxib and Acetaminophen in Adenotonsillectomy and Postoperative Pain, sponsored by NYU Langone Health. Not yet recruiting at 1 site in United States. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by NYU Langone Health · Phase 1/2, Interventional, and Treatment
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).
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.
5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's planned enrollment of 500 is above the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →NYU Langone Health is the lead sponsor of 1,421 studies on the registry; 254 are open to participants now.
Of its 231 completed or terminated interventional studies of FDA-regulated products, 195 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Drug: Celecoxib · Drug: Acetaminophen · Drug: Dexamethasone
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.
Drug: Acetaminophen · Drug: Dexamethasone
Oral celecoxib 6 mg/kg per dose (max 100 mg), given the evening before surgery and the morning of surgery
Intra-operative acetaminophen (Tylenol)
Intra-operative dexamethasone (Decadron)
Rescue Analgesic Use in PACU
Chart-verified rescue analgesic consumption in the post-anesthesia care unit (PACU), expressed in morphine equivalents (PO/IV).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Up to Hour 72 Post-Operation
PACU Length of Stay
Time frame: 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.
Time frame: 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.
Time frame: Up to Hour 72 Post-Operation
Return to normal activity
Time from surgery to resumption of normal activity, as recorded in patient/family diary.
Time frame: 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.
Time frame: Up to Day 3 Post-Operation
Post-operative bleeding events
Primary and secondary bleeding events identified by chart review.
Time frame: Up to Day 14 Post-Operation
Healthcare utilization
Proportion of participants with emergency visits, readmissions, MyChart messages, or pre- or post-operative phone calls.
Time frame: Up to Day 30 Post-Operation.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research
Access criteria: Requests should be directed to christina.yang@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Celecoxib