[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560414":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":60,"collaborators":62,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":25,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":93,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Duke University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Short acting opioids: Fentanyl\u002FHydromorphone","ACTIVE_COMPARATOR","Per Routine Care",[13],"Drug: Fentanyl\u002FHydromorphone",{"label":15,"type":10,"description":16,"interventionNames":17},"Long acting opioid: Methadone","Initial Dosing: 0.15 mg\u002Fkg age-ideal body weight in children age 3 - \\\u003C 12 years and 0.2 mg\u002Fkg age-ideal body weight in adolescents age 12 - 17 years.\n\nDose escalation (possible, based on interim analysis): 0.2 mg\u002Fkg age-ideal body weight in children age 3 - \\\u003C 12 years and 0.25 mg\u002Fkg age-ideal body weight in adolescents age 12 - 17 years.",[18],"Drug: Methadone",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Methadone","Single-dose intraoperative intravenous methadone with initial dose at 0.15 mg\u002Fkg in children and 0.2 mg\u002Fkg in adolescents.",[15],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Fentanyl\u002FHydromorphone","Per routine care, given as needed",[9],[31],{"name":32,"affiliation":5,"role":33},"Lisa M. Einhorn, MD","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Lisa M Einhorn, MD","CONTACT","9196814877","lisa.einhorn@duke.edu",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Duke University Medical Center","RECRUITING","Durham","North Carolina","27710","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-78.89862,35.99403,{"lat":53,"lon":52},[56,58],{"name":57,"role":37,"phone":25,"phoneExt":25,"email":39},"Lisa Einhorn",{"name":59,"role":33,"phone":25,"phoneExt":25,"email":25},"Lisa M. Einhorn, M.D.",{"type":61,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[63,66],{"name":64,"class":65},"National Institutes of Health (NIH)","NIH",{"name":67,"class":65},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","100560414","phase-4-optimization-of-pediatric-tonsillectomy-to-improve-analgesia-100560414",false,"NCT06576830","Optimization of Pediatric Tonsillectomy to IMprove AnaLgesia","Single-Dose Intraoperative Methadone for Pain Management in Pediatric Tonsillectomy: A Randomized Double Blind Clinical Trial","OPTIMAL","Inclusion Criteria:\n\n1. Age \\>= 3 and \\\u003C 18 years\n2. Elective tonsillectomy +\u002F- adenoidectomy\n3. Signed informed consent by parent or legal guardian\n4. Children \\>= 12 years must provide signed written consent, Children \\>= 7 years must provide verbal assent\n5. Negative pregnancy test within 48 hours for post pubescent females\n\nExclusion Criteria:\n\n1. History of chronic kidney or liver disease\n2. Current diagnosis of a chronic pain disorder\n3. Planned admission to the Pediatric Intensive Care Unit (PICU)\n4. Additional procedures under general anesthesia for which opioids would be prescribed",true,"ALL","3 Years","17 Years",{"count":81,"type":82},440,"ESTIMATED","INTERVENTIONAL",[85],"PHASE4","The purpose of this study is to compare the use of short acting opioids (fentanyl\u002Fhydromorphone) with long acting opioids (methadone) for pain control following tonsillectomy surgery in children and adolescents.",[88,89,90,91,92],"Pain, Postoperative","Tonsillar Hypertrophy","Tonsillitis","Pediatric Sleep Apnea","Sleep-Disordered Breathing",[22,94,95],"Tonsillectomy","Opioid","2025-12-01",{"date":98,"type":99},"2025-12-05","ACTUAL",{"date":101,"type":99},"2024-11-21",{"date":103,"type":82},"2029-06-01",{"name":5,"class":6},1]