[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564196":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":41,"locations":51,"responsibleParty":107,"collaborators":111,"id":115,"slug":116,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":117,"sex":123,"minAge":124,"maxAge":125,"enrollmentInfo":126,"targetDuration":46,"studyType":129,"phases":130,"briefSummary":132,"conditions":133,"keywords":46,"overallStatus":90,"whyStopped":46,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"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",[34,37],{"name":35,"affiliation":5,"role":36},"Senthilkumar Sadhasivam, MD","PRINCIPAL_INVESTIGATOR",{"name":38,"affiliation":39,"role":40},"Alisha Maslanka, BS","University of Pittsburgh, UPMC","STUDY_DIRECTOR",[42,48],{"name":43,"role":44,"phone":45,"phoneExt":46,"email":47},"Senthilkumar Sadhasivam, MD,MPH, MBA, FASA","CONTACT","4126474484",null,"sadhasivams@upmc.edu",{"name":49,"role":44,"phone":46,"phoneExt":46,"email":50},"Dayana Alsamsam, BSPS, MSc","alsamsamd@upmc.edu",[52,72,88],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"UCSF Benioff Children's Hospital","NOT_YET_RECRUITING","Oakland","California","94618","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-122.2708,37.80437,{"lat":64,"lon":63},[67,71],{"name":68,"role":44,"phone":69,"phoneExt":46,"email":70},"Anshuman Sharma, MD","(510) 428-3000","Anshuman.sharma@UCSF.edu",{"name":68,"role":36,"phone":46,"phoneExt":46,"email":46},{"facility":73,"status":54,"city":74,"state":75,"zip":76,"country":58,"countryCode":59,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Cincinnati Children's Hospital Medical Center","Cincinnati","Ohio","45229",{"type":61,"coordinates":78},[79,80],-84.51439,39.12711,{"lat":80,"lon":79},[83,87],{"name":84,"role":44,"phone":85,"phoneExt":46,"email":86},"Vidya Chidambaran, MD","(513) 636-4408","vidya.chidambaran@cchmc.org",{"name":84,"role":36,"phone":46,"phoneExt":46,"email":46},{"facility":89,"status":90,"city":91,"state":92,"zip":93,"country":58,"countryCode":59,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"UPMC Children's Hospital","RECRUITING","Pittsburgh","Pennsylvania","15213",{"type":61,"coordinates":95},[96,97],-79.99589,40.44062,{"lat":97,"lon":96},[100,103,106],{"name":101,"role":44,"phone":102,"phoneExt":46,"email":47},"Senthilkumar Sadhasivam, MD, MPH","412-647-4484",{"name":38,"role":44,"phone":104,"phoneExt":46,"email":105},"412-491-2748","maslankaaa@upmc.edu",{"name":35,"role":36,"phone":46,"phoneExt":46,"email":46},{"type":108,"investigatorFullName":109,"investigatorTitle":110,"investigatorAffiliation":5,"oldNameTitle":46,"oldOrganization":46},"SPONSOR_INVESTIGATOR","Senthil Sadhasivam","Professor",[112],{"name":113,"class":114},"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":127,"type":128},500,"ESTIMATED","INTERVENTIONAL",[131],"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.",[134],"Pediatric Cardiac Surgery","2026-08-05",{"date":137,"type":138},"2026-08-07","ACTUAL",{"date":140,"type":138},"2025-12-17",{"date":142,"type":128},"2029-08-31",{"name":109,"class":6},3]