[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564232":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":48,"responsibleParty":92,"collaborators":96,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":102,"sex":108,"minAge":109,"maxAge":110,"enrollmentInfo":111,"targetDuration":43,"studyType":114,"phases":115,"briefSummary":117,"conditions":118,"keywords":43,"overallStatus":74,"whyStopped":43,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"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 administered 4 hours after the 1st dose) and postoperatively, up to 4 additional IV or oral 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","The comparator standard-of-care non-methadone-based analgesia arm will include 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","Methadone intervention includes 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 administered 4 hours after the 1st dose) and postoperatively, up to 4 additional IV or oral 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":30,"armGroupLabels":31,"otherNames":32},"Non-methadone based group","Non-methadone intervention includes standard opioid analgesia protocol without intra- and post-operative methadone per the current site standards. Postoperative pain medication is recommended when reported pain level is considered moderate or higher (≥4 on NRS and FLACC).",[15],[33],"Non-methadone",[35],{"name":36,"affiliation":5,"role":37},"Senthilkumar Sadhasivam, MD","PRINCIPAL_INVESTIGATOR",[39,45],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Senthilkumar Sadhasivam, MD, MPH, MBA, FASA","CONTACT","4126474484",null,"sadhasivams@upmc.edu",{"name":46,"role":41,"phone":43,"phoneExt":43,"email":47},"Dayana Alsamsam, BSPS, MSc","alsamsamd@upmc.edu",[49,72],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Cincinnati Children's Hospital Medical Center","NOT_YET_RECRUITING","Cincinnati","Ohio","45229","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-84.51439,39.12711,{"lat":61,"lon":60},[64,68,71],{"name":65,"role":41,"phone":66,"phoneExt":43,"email":67},"Vidya Chidambaran, MD","5134970454","vidya.chidambaran@cchmc.org",{"name":69,"role":41,"phone":43,"phoneExt":43,"email":70},"Sean Evans, CIP","sean.evans@cchmc.org",{"name":65,"role":37,"phone":43,"phoneExt":43,"email":43},{"facility":73,"status":74,"city":75,"state":76,"zip":77,"country":55,"countryCode":56,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"UPMC Children's Hospital","RECRUITING","Pittsburgh","Pennsylvania","15213",{"type":58,"coordinates":79},[80,81],-79.99589,40.44062,{"lat":81,"lon":80},[84,87,91],{"name":85,"role":41,"phone":86,"phoneExt":43,"email":44},"Senthilkumar Sadhasivam, MD, MPH","412-647-4484",{"name":88,"role":41,"phone":89,"phoneExt":43,"email":90},"Amy Monroe, MPH","4126236283","monroeal@upmc.edu",{"name":36,"role":37,"phone":43,"phoneExt":43,"email":43},{"type":93,"investigatorFullName":94,"investigatorTitle":95,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"SPONSOR_INVESTIGATOR","Senthil Sadhasivam","Professor",[97],{"name":98,"class":99},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100564232","phase-3-evaluation-of-analgesia-for-spine-fusion-elective-surgery-in-children-100564232",false,"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)","PRECISE","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","ALL","10 Years","18 Years",{"count":112,"type":113},500,"ESTIMATED","INTERVENTIONAL",[116],"PHASE3","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.",[119],"Idiopathic Scoliosis","2026-04-29",{"date":122,"type":123},"2026-05-05","ACTUAL",{"date":125,"type":123},"2025-10-30",{"date":127,"type":113},"2029-08-31",{"name":94,"class":6},2]