[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564196":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":47,"responsibleParty":71,"collaborators":75,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":81,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":42,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":42,"overallStatus":50,"whyStopped":42,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Methadone-Based ERAS Group","EXPERIMENTAL","The methadone-based standardized analgesia intervention arm will include standardized perioperative care and analgesia, including intraoperative intravenous methadone (1st dose: 0.1 mg\u002Fkg up to a maximum of 5 mg before incision; 2nd dose: 0.1 mg\u002Fkg up to a maximum of 5 mg 4 hours after 1st dose) and postoperatively, up to 4 oral or IV doses of methadone (0.1 mg\u002Fkg up to a maximum of 5 mg) every 12 hours before discharge as part of standardized multimodal analgesia in the hospital setting.",[13],"Drug: Methadone based ERAS",{"label":15,"type":16,"description":17,"interventionNames":18},"Non-Methadone-Based Group","ACTIVE_COMPARATOR","Children randomized to the standard-of-care arm will receive standard opioid analgesia protocol without intra- and post-operative methadone per the current site standards.",[19],"Drug: Non-methadone based group",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Methadone based ERAS","Children randomized to the methadone arm will include standardized perioperative care and analgesia, including intraoperative intravenous methadone (1st dose: 0.1 mg\u002Fkg up to a maximum of 5 mg before incision; 2nd dose: 0.1 mg\u002Fkg up to a maximum of 5 mg 4 hours after 1st dose) and postoperatively, up to 4 oral or IV doses of methadone (0.1 mg\u002Fkg up to a maximum of 5 mg) every 12 hours before discharge as part of standardized multimodal analgesia in the hospital setting.",[9],[27],"Methadone-Based",{"type":22,"name":29,"description":17,"armGroupLabels":30,"otherNames":31},"Non-methadone based group",[15],[32],"Standard Care",[34],{"name":35,"affiliation":5,"role":36},"Senthilkumar Sadhasivam, MD","PRINCIPAL_INVESTIGATOR",[38,44],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Senthilkumar Sadhasivam, MD,MPH, MBA, FASA","CONTACT","4126474484",null,"sadhasivams@upmc.edu",{"name":45,"role":40,"phone":42,"phoneExt":42,"email":46},"Dayana Alsamsam, BSPS, MSc","alsamsamd@upmc.edu",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"UPMC Children's Hospital","RECRUITING","Pittsburgh","Pennsylvania","15213","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-79.99589,40.44062,{"lat":60,"lon":59},[63,66,70],{"name":64,"role":40,"phone":65,"phoneExt":42,"email":43},"Senthilkumar Sadhasivam, MD, MPH","412-647-4484",{"name":67,"role":40,"phone":68,"phoneExt":42,"email":69},"Amy Monroe, MPH","4126236283","monroeal@upmc.edu",{"name":35,"role":36,"phone":42,"phoneExt":42,"email":42},{"type":72,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"SPONSOR_INVESTIGATOR","Senthil Sadhasivam","Professor",[76],{"name":77,"class":78},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100564196","phase-3-evaluation-of-analgesia-for-cardiac-elective-surgery-in-children-100564196",false,"NCT06626035","Evaluation of Analgesia for Cardiac Elective Surgery in Children","Prospective Randomized Evaluation of Analgesia for Cardiac Elective Surgery in Children (PRECISE Cardiac Trial)","PRECISE","Inclusion Criteria:\n\n* Children aged 3-years - \\\u003C18 years\n* ASA physical status 1, 2, or 3\n* Participant or legal guardian can speak and read English or Spanish\n* Undergoing the following cardiac surgeries (Categories 1 \\& 2) that are associated with significant acute surgical pain\n\nSTS Category 1:\n\n* ASD, PFO closure\n* VSD repairs,\n* Aortic stenosis sub-valvular repair\n* ASD and Partial anomalous venous return repair\n* AV canal transitional\n* Conduit replacement\n* Valve replacement (AVR, PVR)\n* TOF repair without ventriculostomy\n\nSTS Category 2:\n\n* Glenn shunt (on Bypass only)\n* Fontan surgery (on Bypass only)\n* Pulmonary artery plasty (main)\n* Left Atrium (LA) to Pulmonary Artery (PA) conduit replacement.\n\nExclusion Criteria:\n\n* Pregnant patients\n* Methadone allergy\n* Preoperative prolonged QTc more than 460 msec (-30 days to 0 day)\n* Subjects undergoing concomitant treatment with known cytochrome P450 inhibitors included in methadone labeling (i.e. macrolides (e.g. erythromycin), azole-antifungal agents (e.g. ketoconazole, voriconazole), protease inhibitors (e.g. ritonavir), fluconazole, SSRIs (e.g. sertraline, fluvoxamine)\n* Preoperative opioid use within 30 days before surgery\n* History of severe sleep apnea (have a sleep study with an AHI index score more than 10 or clinical signs of sleep disordered breathing - snoring, daytime drowsiness)\n* Significant liver, kidney, neurological disease, developmental delay, or any other co-existing medical condition per discretion of the clinical investigator","ALL","3 Years","18 Years",{"count":91,"type":92},500,"ESTIMATED","INTERVENTIONAL",[95],"PHASE3","The purpose of this study is to look at a standardized methadone-based enhanced recovery after surgery protocol following pediatric cardiac surgery. This study will consist of randomly assigning children to receive the methadone-based recovery procedures or to receive current standard of care recovery procedures. Randomly assigning means that there is a 50\u002F50 chance, like a coin flip, of being assigned to either research group.",[98],"Pediatric Cardiac Surgery","2026-04-30",{"date":101,"type":102},"2026-05-05","ACTUAL",{"date":104,"type":102},"2025-12-17",{"date":106,"type":92},"2029-08-31",{"name":73,"class":6},1]