[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590045":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":38,"responsibleParty":56,"collaborators":25,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":25,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":82,"overallStatus":41,"whyStopped":25,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Duke University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Methadone","ACTIVE_COMPARATOR","Methadone 0.2-0.25 mg\u002Fkg actual body weight",[13],"Drug: Methadone hydrochloride",{"label":15,"type":10,"description":16,"interventionNames":17},"Fentanyl\u002FHydromorphone","Fentanyl\u002FHydromorphone per routine care",[18],"Drug: Fentanyl\u002FHydromorphone",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Methadone hydrochloride","Initial dosing 0.2mg\u002Fkg, potential to escalate to 0.25mg\u002Fkg following interim analysis",[9],null,{"type":21,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Per routine care",[15],[30],{"name":31,"affiliation":5,"role":32},"Lisa M. Einhorn, M.D.","PRINCIPAL_INVESTIGATOR",[34],{"name":31,"role":35,"phone":36,"phoneExt":25,"email":37},"CONTACT","919 970 2805","lisa.einhorn@duke.edu",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Duke University Medical Center","RECRUITING","Durham","North Carolina","27705","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-78.89862,35.99403,{"lat":51,"lon":50},[54],{"name":31,"role":35,"phone":55,"phoneExt":25,"email":37},"919-970-2805",{"type":57,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100590045","phase-4-optimizing-perioperative-analgesia-to-lower-pain-following-cleft-palate-surgery-100590045",false,"NCT06962306","Optimizing Perioperative Analgesia to Lower Pain Following Cleft Palate Surgery","Perioperative Methadone Use for Cleft Palate Repair: A Randomized Controlled Trial","OPAL-Cleft","Inclusion Criteria:\n\n* Age 6 months to 4 years of age\n* Primary cleft palate repair\n* Signed informed consent by parent or legal guardian\n\nExclusion Criteria:\n\n* History of chronic kidney or liver disease\n* Planned admission to the Pediatric Intensive Care Unit (PICU)\n* Additional procedures under general anesthesia for which opioids would be prescribed\n* Any patient ineligible for study participation at the discretion of the investigators","ALL","6 Months","4 Years",{"count":70,"type":71},60,"ESTIMATED","INTERVENTIONAL",[74],"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 cleft palate surgery in infants and young children.",[77,78,79,80,81],"Cleft Palate","Pain","Postoperative Care","Perioperative Care","Children",[83,84,85,9],"Cleft palate surgery","Perioperative pain management","Analgesia","2026-04-10",{"date":88,"type":89},"2026-04-14","ACTUAL",{"date":91,"type":89},"2025-06-04",{"date":93,"type":71},"2027-07-04",{"name":5,"class":6},1]