[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659846":3},{"organization":4,"outcomesModule":7,"designInfo":48,"detailedDescription":57,"studyPopulation":26,"armGroups":58,"interventions":72,"overallOfficials":86,"centralContacts":92,"locations":101,"responsibleParty":113,"collaborators":26,"id":115,"slug":116,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":26,"eligibilityCriteria":121,"healthyVolunteers":117,"sex":122,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":26,"studyType":128,"phases":129,"briefSummary":132,"conditions":133,"keywords":136,"overallStatus":141,"whyStopped":26,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"NYU Langone Health","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":23,"otherOutcomes":26},[9,13,16,20],{"measure":10,"description":11,"timeFrame":12},"Rescue Analgesic Use in PACU","Chart-verified rescue analgesic consumption in the post-anesthesia care unit (PACU), expressed in morphine equivalents (PO\u002FIV).","PACU Stay (PACU arrival to PACU discharge) - Approximately 3 Hours",{"measure":14,"description":15,"timeFrame":12},"Time to First Rescue Analgesic in PACU","Time to first chart-verified rescue analgesic consumption in the post-anesthesia care unit (PACU).",{"measure":17,"description":18,"timeFrame":19},"Rescue Opioid Analgesic Use within 72 Hours Post-Op","Rescue opioid analgesic consumption, expressed in morphine equivalents (PO\u002FIV), within 72 hours after surgery.","Up to Hour 72 Post-Operation",{"measure":21,"description":22,"timeFrame":19},"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.",[24,27,30,33,36,40,44],{"measure":25,"description":26,"timeFrame":12},"PACU Length of Stay",null,{"measure":28,"description":29,"timeFrame":12},"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.",{"measure":31,"description":32,"timeFrame":19},"Return to normal diet","Time from surgery to resumption of normal oral intake, as recorded in patient\u002Ffamily diary.",{"measure":34,"description":35,"timeFrame":19},"Return to normal activity","Time from surgery to resumption of normal activity, as recorded in patient\u002Ffamily diary.",{"measure":37,"description":38,"timeFrame":39},"Medication adverse events","Adverse medication events (e.g., nausea\u002Fvomiting, renal\u002FGI effects) recorded in the patient\u002Ffamily diary.","Up to Day 3 Post-Operation",{"measure":41,"description":42,"timeFrame":43},"Post-operative bleeding events","Primary and secondary bleeding events identified by chart review.","Up to Day 14 Post-Operation",{"measure":45,"description":46,"timeFrame":47},"Healthcare utilization","Proportion of participants with emergency visits, readmissions, MyChart messages, or pre- or post-operative phone calls.","Up to Day 30 Post-Operation.",{"allocation":49,"interventionModel":50,"interventionModelDescription":26,"primaryPurpose":51,"observationalModel":26,"timePerspective":26,"maskingInfo":52},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":53,"maskingDescription":54,"whoMasked":55},"SINGLE","Open-label. Participants and care providers are aware of treatment assignment, reflecting the real-world dosing burden on families and supporting recruitment feasibility. To mitigate potential bias, the primary outcome (analgesic rescue consumption) is an objective, chart-verified measure, and secondary subjective outcomes are collected by study personnel blinded to treatment assignment.",[56],"OUTCOMES_ASSESSOR","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.\n\nMultimodal arm: oral celecoxib (6 mg\u002Fkg, 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.\n\nApproach: 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.\n\nPrimary 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\u002FIV, time to rescue); PACU length of stay; PACU pain score (Wong-Baker (\\>5) vs. FACES (\\\u003C5) Pain Rating Scale); a 72-hour patient\u002Ffamily pain diary including time to resumption of normal oral intake and activity.\n\nSecondary 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\u002Fvomiting, renal\u002FGI effects). Outcomes: patient\u002Ffamily 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.\n\nSecondary 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.",[59,67],{"label":60,"type":61,"description":62,"interventionNames":63},"Pre-operative Celecoxib","EXPERIMENTAL","Pediatric patients (2-18 years, \\>10 kg) undergoing adenotonsillectomy who receive oral celecoxib (6 mg\u002Fkg, 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.",[64,65,66],"Drug: Celecoxib","Drug: Acetaminophen","Drug: Dexamethasone",{"label":68,"type":69,"description":70,"interventionNames":71},"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.",[65,66],[73,78,82],{"type":74,"name":75,"description":76,"armGroupLabels":77,"otherNames":26},"DRUG","Celecoxib","Oral celecoxib 6 mg\u002Fkg per dose (max 100 mg), given the evening before surgery and the morning of surgery",[60],{"type":74,"name":79,"description":80,"armGroupLabels":81,"otherNames":26},"Acetaminophen","Intra-operative acetaminophen (Tylenol)",[68,60],{"type":74,"name":83,"description":84,"armGroupLabels":85,"otherNames":26},"Dexamethasone","Intra-operative dexamethasone (Decadron)",[68,60],[87,90],{"name":88,"affiliation":5,"role":89},"Christina Yang, MD","PRINCIPAL_INVESTIGATOR",{"name":91,"affiliation":5,"role":89},"Zahrah Taufique, MD",[93,97],{"name":91,"role":94,"phone":95,"phoneExt":26,"email":96},"CONTACT","646-501-7890","Zahrah.Taufique@nyulangone.org",{"name":98,"role":94,"phone":99,"phoneExt":26,"email":100},"Jamie Schlacter, MD","224-545-9048","Jamie.Schlacter@nyulangone.org",[102],{"facility":5,"status":26,"city":103,"state":103,"zip":104,"country":105,"countryCode":106,"cosmosGeoPoint":107,"geoPoint":112,"contacts":26},"New York","10016","United States","US",{"type":108,"coordinates":109},"Point",[110,111],-74.00597,40.71427,{"lat":111,"lon":110},{"type":114,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100659846","phase-1-preoperative-celecoxib-and-acetaminophen-versus-acetaminophen-alone-for-pain-control-after-pediatric-adenotonsillectomy-100659846",false,"NCT07870447","Preoperative Celecoxib and Acetaminophen Versus Acetaminophen Alone for Pain Control After Pediatric Adenotonsillectomy","An Open-Label, Randomized Study of Preoperative Celecoxib After Pediatric Adenotonsillectomy","Inclusion Criteria:\n\n* Pediatric patients 2-18 years of age\n* Weighing greater than 10 kg\n* Undergoing adenotonsillectomy\n* English- or Spanish-speaking patients\n\nExclusion Criteria:\n\n* Any adjunct procedure other than bilateral myringotomy tubes (BMT) or direct laryngoscopy and bronchoscopy (DLB) without bronchoalveolar lavage (BAL)\n* Bleeding disorders\n* Allergy to NSAIDs\n* Allergy to acetaminophen (Tylenol)\n* Pregnancy","ALL","2 Years","18 Years",{"count":126,"type":127},500,"ESTIMATED","INTERVENTIONAL",[130,131],"PHASE1","PHASE2","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).",[134,135],"Adenotonsillectomy","Postoperative Pain",[75,79,137,138,139,140,134],"Multimodal analgesia","Preoperative analgesia","Postoperative pain","Pediatric","NOT_YET_RECRUITING","2026-10-06",{"date":144,"type":145},"2026-10-13","ACTUAL",{"date":147,"type":127},"2026-11-01",{"date":149,"type":127},"2029-12-30",{"name":5,"class":6},1]