[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Senthil Sadhasivam\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":146},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,42,62,90,115],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"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":21,"type":22},500,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28],"Pediatric Cardiac Surgery","RECRUITING","2026-04-30",{"date":32,"type":33},"2026-05-05","ACTUAL",{"date":35,"type":33},"2025-12-17",{"date":37,"type":22},"2029-08-31",{"name":39,"class":40},"Senthil Sadhasivam","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":15,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":19,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":60,"locationsCount":61},"100564232","phase-3-evaluation-of-analgesia-for-spine-fusion-elective-surgery-in-children-100564232","NCT06626503","Evaluation of Analgesia for Spine Fusion Elective Surgery in Children","Prospective Randomized Evaluation of Analgesia for Spine Fusion Elective Surgery in Children (PRECISE Spine Trial)","Inclusion Criteria:\n\n1. Age 10 - \\\u003C 18 years\n2. American Society of Anesthesiologists (ASA) Physical Status 1 or 2\n3. Undergoing PSF for idiopathic scoliosis\n4. Participant or legal guardian can speak and read English or Spanish\n\nExclusion Criteria:\n\n1. Pregnant patients\n2. Methadone allergy\n3. Preoperative prolonged QTc more than 460 msec (-30 days to 0 day)\n4. 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)\n5. Preoperative opioid use within 30 days before surgery\n6. History of severe sleep apnea, defined as a prior sleep study demonstrating an apnea-hypopnea index (AHI) greater than 10.\n7. Significant liver, kidney, neurological disease, developmental delay, or any other co-existing medical condition per discretion of the clinical investigator","10 Years",{"count":21,"type":22},[25],"The multicenter PRECISE Analgesia (Prospective Randomized Evaluation of Analgesia for Idiopathic Scoliosis Spine Fusion Elective Surgery in Children) trials will a) implement and investigate the efficacy and safety of multidose methadone-based standardized enhanced recovery after surgery (ERAS) protocol, and b) develop personalized ERAS protocols including precision methadone and oxycodone dosing and c) personalized analgesia for the safe and effective opioid-sparing management of surgical pain after posterior spine fusion (PSF) in children.",[54],"Idiopathic Scoliosis","2026-04-29",{"date":32,"type":33},{"date":58,"type":33},"2025-10-30",{"date":37,"type":22},{"name":39,"class":40},2,{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":19,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":23,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},"100468495","personalized-perioperative-analgesia-platform-ppap-for-cesarean-section-100468495","NCT05380531","Personalized Perioperative Analgesia Platform (PPAP) for Cesarean Section","PPAP C-Section","Inclusion Criteria:\n\nAdult women (\\>18 yr) All races American Society of Anesthesiologists Classification (ASA) physical status: 1 to 3 undergoing elective Cesarean section that are willing to receive in-patient opioids.\n\nExclusion Criteria:\n\n1. Health conditions including uncontrolled diabetes (gestational or pre-existing) or hypertension (pre-eclampsia, eclampsia, or chronic)\n2. Any history of opioid misuse before or during pregnancy-per self-report and clinical notes\n3. Preoperative severe pain and opioid use\u002Fmisuse, allergy to oxycodone\n4. Allergy to oxycodone\n5. Significant neurological disorders, liver and renal diseases",true,"FEMALE",{"count":72,"type":22},700,[74],"NA","The purpose of this collaborative CTSA (Clinical and Translational Science Award) application is to develop an innovative perioperative precision analgesia platform (PPAP) to improve analgesia and reduce serious immediate and long-term adverse outcomes of perioperative opioids in breastfeeding mothers and their infants",[77,78],"Cesarean Section Complications","Opioid Use",[80],"Opioid Exposure","2026-04-08",{"date":83,"type":33},"2026-04-14",{"date":85,"type":33},"2022-12-05",{"date":87,"type":22},"2027-10-30",{"name":39,"class":40},4,{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":97,"enrollmentInfo":98,"targetDuration":4,"studyType":23,"phases":100,"briefSummary":101,"conditions":102,"keywords":105,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":114,"locationsCount":5},"100467503","personalized-perioperative-analgesia-platform-ppap-for-pediatric-spine-fusion-surgery-sirb-100467503","NCT05367609","Personalized Perioperative Analgesia Platform (PPAP) for Pediatric Spine Fusion Surgery (sIRB)","PPAP Spine","Inclusion Criteria:\n\n* Children ages 10 to 21\n* ASA physical status 1 to 3\n* Undergoing Posterior-Lateral Spinal Fusion\n* Receives in-patient opioids\n* Prescribed opioids at discharge\n\nExclusion Criteria:\n\n* Serious illness\n* Preoperative severe pain\n* Preoperative opioid use or misuse","21 Years",{"count":99,"type":22},300,[74],"The purpose of this collaborative CTSA application is to develop an innovative perioperative precision analgesia platform (PPAP) to improve analgesia and reduce serious immediate and long-term adverse outcomes of perioperative opioids in children undergoing painful surgery.",[103,104],"PPAP","Spine Fusion",[103,106,107],"Pediatric","Spine Fusion Surgery","2026-04-07",{"date":110,"type":33},"2026-04-13",{"date":112,"type":33},"2022-09-20",{"date":87,"type":22},{"name":39,"class":40},{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":69,"sex":70,"minAge":19,"maxAge":4,"enrollmentInfo":123,"targetDuration":125,"studyType":126,"phases":4,"briefSummary":127,"conditions":128,"keywords":132,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":41},"100356620","opioid-use-disorder-in-pregnancy-in-long-term-maternalinfant-outcomes-100356620","NCT03923374","Opioid Use Disorder in Pregnancy in Long-Term Maternal\u002FInfant Outcomes","Effects of Opioid Use Disorder in Pregnancy in Long-Term Maternal\u002FInfant Outcomes","Mother\u002FBabyOUD","Inclusion Criteria:\n\n* Age greater 18 years\n* Currently taking Buprenorphine for Opioid Use Disorder and enrolled in a prenatal opioid maintenance program in the antenatal clinic at IU Health University Hospital.\n* Pregnant with single baby\n* Planned delivery at Methodist, University or Riley Hospital\n\nExclusion Criteria:\n\n* Serious maternal medical illness as deemed by study physician or investigator.\n* Known or suspected major fetal\u002Fneonatal congenital abnormalities.",{"count":124,"type":22},600,"2 Years","OBSERVATIONAL","The objective of this study is to better understand the comprehensive integration of both clinical and genetic factors that will help to identify mothers who could be at an increased risk of poor response to opioid substitution and infants at risk of significant neonatal abstinence syndrome (NAS).",[129,130,131],"Opioid-use Disorder","Opioid Use, Unspecified","Buprenorphine Dependence",[133,134,135,136,137],"Pregnant with Opioid Use Disorder","Opioid Use Disorder ( OUD)","Subutex","Buprenorphine","Pregnant taking buprenorphine\u002Fsubutex","2025-12-16",{"date":140,"type":33},"2025-12-18",{"date":142,"type":33},"2018-09-15",{"date":144,"type":22},"2026-12-30",{"name":39,"class":40},""]