[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100318590":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":30,"studyPopulation":31,"armGroups":32,"interventions":42,"overallOfficials":75,"centralContacts":80,"locations":90,"responsibleParty":260,"collaborators":264,"id":268,"slug":11,"hasResults":269,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":273,"eligibilityCriteria":274,"healthyVolunteers":269,"sex":275,"minAge":276,"maxAge":277,"enrollmentInfo":278,"targetDuration":11,"studyType":281,"phases":11,"briefSummary":282,"conditions":283,"keywords":11,"overallStatus":128,"whyStopped":11,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":295},{"fullName":5,"class":6},"Duke University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9,13,15,18,20,22,24,26],{"measure":10,"description":11,"timeFrame":12},"Clearance (CL) or apparent oral clearance (CL\u002FF)",null,"up to 48 hours post dose",{"measure":14,"description":11,"timeFrame":12},"Volume of distribution (V) or apparent oral volume of distribution (V\u002FF)",{"measure":16,"description":11,"timeFrame":17},"Elimination rate constant (ke)","up to 48 hrs post dose",{"measure":19,"description":11,"timeFrame":17},"Half-life (t1\u002F2)",{"measure":21,"description":11,"timeFrame":17},"Absorption rate constant (ka)",{"measure":23,"description":11,"timeFrame":17},"Area under the curve (AUC)",{"measure":25,"description":11,"timeFrame":17},"Maximum concentration (CMAX)",{"measure":27,"description":11,"timeFrame":17},"Time to achieve maximum concentration (TMAX)",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":6,"timePerspective":29,"maskingInfo":11},"PROSPECTIVE","This is a research study to find out what the side effects are of certain drugs that are commonly used for pain and to put people to sleep for surgery. The researchers also want to know how the drug is broken down in the body. Participants will be given these drugs as they are prescribed by their regular doctor. As part of the participant's standard of care, doctors will perform tests, ask questions, review medical information and measure vital signs (heart rate, blood pressure, etc). The researchers will collect information that doctors have already written in the medical records. The research study team will collect blood from participants at certain time points depending on when the participant was first given the drug (up to 5 samples over the course of 10 to 48 hours). Examples of current and upcoming anesthetics and analgesics include, but are not limited to: ketorolac (Toradol), ketamine (Ketalar), oxycodone (OxyContin), and morphine (Kadian, MS Contin).","Approximately 60 participants will be enrolled to each of the study drug of interests (DOI) cohorts. Participants who satisfy eligibility criteria and are receiving one or more DOIs per standard of care will be consented into the study and assigned to the corresponding DOI cohort. DOI cohort assignments will be at the discretion of the treating physician based on the DOIs that are administered per standard of care. Participants will be selected from a variety of centers including but not limited to trauma and intensive care units. Participants will not be randomized. Participants may count towards 1 or more DOIs within the same 90-day period.",[33],{"label":34,"type":11,"description":35,"interventionNames":36},"Drug of Interest","Individuals receiving anesthetics or analgesics per standard of care",[37,38,39,40,41],"Drug: Ketorolac Tromethamine","Drug: Hydromorphone","Drug: Ketamine","Drug: Oxycodone","Drug: Morphine",[43,50,57,63,69],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"DRUG","Ketorolac Tromethamine","IV ketorolac will be given per standard of care, not prescribed for this study",[34],[49],"Toradol",{"type":44,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"Hydromorphone","IV Hydromorphone will be given per standard of care, not prescribed for this study",[34],[55,56],"Hydromorphone hydrochloride","Dilaudid",{"type":44,"name":58,"description":59,"armGroupLabels":60,"otherNames":61},"Ketamine","IV Ketamine will be given per standard of care, not prescribed for this study",[34],[62],"Ketamine Hydrochloride",{"type":44,"name":64,"description":65,"armGroupLabels":66,"otherNames":67},"Oxycodone","PO Oxycodone(solution or tablet) will be given per standard of care, not prescribed for this study",[34],[68],"Oxycodone Hydrochloride",{"type":44,"name":70,"description":71,"armGroupLabels":72,"otherNames":73},"Morphine","IV Morphine will be given per standard of care, not prescribed for this study",[34],[74],"Morphine Sulfate",[76],{"name":77,"affiliation":78,"role":79},"Chi Hornik, PharmD","Duke Clinical Research Institute","PRINCIPAL_INVESTIGATOR",[81,86],{"name":82,"role":83,"phone":84,"phoneExt":11,"email":85},"Kady-Ann Steen-Burrell, PhD","CONTACT","919-530-9711","kady.ann.steen.burrell@duke.edu",{"name":87,"role":83,"phone":88,"phoneExt":11,"email":89},"Cheryl Alderman","919-668-8349","cheryl.alderman@duke.edu",[91,105,116,126,145,155,161,180,190,209,220,229,250],{"facility":92,"status":93,"city":94,"state":95,"zip":96,"country":97,"countryCode":98,"cosmosGeoPoint":99,"geoPoint":104,"contacts":11},"Lucile Packard Children's Hospital","ACTIVE_NOT_RECRUITING","Stanford","California","94305","United States","US",{"type":100,"coordinates":101},"Point",[102,103],-122.16608,37.42411,{"lat":103,"lon":102},{"facility":106,"status":107,"city":108,"state":109,"zip":110,"country":97,"countryCode":98,"cosmosGeoPoint":111,"geoPoint":115,"contacts":11},"Children's Hospital Colorado","TERMINATED","Aurora","Colorado","80045",{"type":100,"coordinates":112},[113,114],-104.83192,39.72943,{"lat":114,"lon":113},{"facility":117,"status":93,"city":118,"state":119,"zip":120,"country":97,"countryCode":98,"cosmosGeoPoint":121,"geoPoint":125,"contacts":11},"Alfred I. DuPont Hospital for Children","Wilmington","Delaware","19803",{"type":100,"coordinates":122},[123,124],-75.54659,39.74595,{"lat":124,"lon":123},{"facility":127,"status":128,"city":129,"state":130,"zip":131,"country":97,"countryCode":98,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Ann and Robert H. Lurie Childrens Hospital of Chicago","RECRUITING","Chicago","Illinois","60611",{"type":100,"coordinates":133},[134,135],-87.65005,41.85003,{"lat":135,"lon":134},[138,142],{"name":139,"role":83,"phone":140,"phoneExt":11,"email":141},"Amy Fang, MD","1-312-227-4448","zafang@luriechildrens.org",{"name":143,"role":83,"phone":140,"phoneExt":11,"email":144},"Richa Mehta","rmehta@luriechildrens.org",{"facility":146,"status":93,"city":147,"state":148,"zip":149,"country":97,"countryCode":98,"cosmosGeoPoint":150,"geoPoint":154,"contacts":11},"Cardinal Glennon Children's Hospital","St Louis","Missouri","63104",{"type":100,"coordinates":151},[152,153],-90.19789,38.62727,{"lat":153,"lon":152},{"facility":156,"status":93,"city":147,"state":148,"zip":157,"country":97,"countryCode":98,"cosmosGeoPoint":158,"geoPoint":160,"contacts":11},"Washington University School of Medicine","63110",{"type":100,"coordinates":159},[152,153],{"lat":153,"lon":152},{"facility":162,"status":128,"city":163,"state":164,"zip":165,"country":97,"countryCode":98,"cosmosGeoPoint":166,"geoPoint":170,"contacts":171},"Duke University Medical Center","Durham","North Carolina","27701",{"type":100,"coordinates":167},[168,169],-78.89862,35.99403,{"lat":169,"lon":168},[172,176],{"name":173,"role":83,"phone":174,"phoneExt":11,"email":175},"Melissa Harward","(919) 668-3910","Melissa.Harward@duke.edu",{"name":177,"role":83,"phone":178,"phoneExt":11,"email":179},"Chi Hornik","919.970.6680","chi.dang@duke.edu",{"facility":181,"status":93,"city":182,"state":183,"zip":184,"country":97,"countryCode":98,"cosmosGeoPoint":185,"geoPoint":189,"contacts":11},"Oregon Health and Science University","Portland","Oregon","97239",{"type":100,"coordinates":186},[187,188],-122.67621,45.52345,{"lat":188,"lon":187},{"facility":191,"status":128,"city":192,"state":193,"zip":194,"country":97,"countryCode":98,"cosmosGeoPoint":195,"geoPoint":199,"contacts":200},"Medical University of South Carolina","Charleston","South Carolina","29425",{"type":100,"coordinates":196},[197,198],-79.93275,32.77632,{"lat":198,"lon":197},[201,205],{"name":202,"role":83,"phone":203,"phoneExt":11,"email":204},"John Costello, MD","843-792-9570","costello@musc.edu",{"name":206,"role":83,"phone":207,"phoneExt":11,"email":208},"Mary Freeman","843-792-5762","freemanme@musc.edu",{"facility":210,"status":211,"city":212,"state":213,"zip":214,"country":97,"countryCode":98,"cosmosGeoPoint":215,"geoPoint":219,"contacts":11},"Dell Children's Medical Center of Texas","WITHDRAWN","Austin","Texas","78723",{"type":100,"coordinates":216},[217,218],-97.74306,30.26715,{"lat":218,"lon":217},{"facility":221,"status":211,"city":222,"state":213,"zip":223,"country":97,"countryCode":98,"cosmosGeoPoint":224,"geoPoint":228,"contacts":11},"Baylor College of Medicine","Houston","77030",{"type":100,"coordinates":225},[226,227],-95.36327,29.76328,{"lat":227,"lon":226},{"facility":230,"status":128,"city":231,"state":232,"zip":233,"country":234,"countryCode":235,"cosmosGeoPoint":236,"geoPoint":240,"contacts":241},"The Hospital for Sick Children","Toronto","Ontario","M5G 1X8","Canada","CA",{"type":100,"coordinates":237},[238,239],-79.39864,43.70643,{"lat":239,"lon":238},[242,246],{"name":243,"role":83,"phone":244,"phoneExt":11,"email":245},"Yaron Finkelstein","1-416-813-5317","yaron.finkelstein@sickkids.ca",{"name":247,"role":83,"phone":248,"phoneExt":11,"email":249},"Maggie Rumantir","1-416-813-7654","maggie.rumantir@sickkids.ca",{"facility":251,"status":93,"city":252,"state":253,"zip":254,"country":234,"countryCode":235,"cosmosGeoPoint":255,"geoPoint":259,"contacts":11},"Hospital Sainte-Justine","Montreal","Quebec","T3T 1C5",{"type":100,"coordinates":256},[257,258],-73.58781,45.50884,{"lat":258,"lon":257},{"type":261,"investigatorFullName":262,"investigatorTitle":263,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Chi Dang Hornik","Associate Professor of Pediatrics",[265],{"name":266,"class":267},"The Emmes Company, LLC","INDUSTRY","100318590",false,"NCT03427736","Anesthetics and Analgesics in Children","Pharmacokinetics of Anesthetics and Analgesics in Children and Adolescent","ANA01","Inclusion Criteria:\n\n1. 0 to \\\u003C18 years of age at time of enrollment (must see applicable appendix for details as not all appendices enroll across the entire age range)\n2. Parent and\u002For participant (if applicable) is able to understand the consent process and provides informed consent and HIPAA Authorization (if applicable)\n3. Participant provides assent as required by the institutional review board (IRB) or research ethics board (REB)\n4. Receiving one or more drugs of interest (DOI) per local standard of care\n5. Meeting DOI-specific inclusion criteria (See Appendices)\n\nExclusion Criteria:\n\n1. Known pregnancy\n2. Extracorporeal life support (i.e., ECMO, dialysis, ventricular assist device)\n3. Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study","ALL","0 Years","17 Years",{"count":279,"type":280},500,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to characterize the pharmacokinetic (PK) and safety profile of anesthetics and analgesics in children and adolescents.",[284,285],"Anesthesia","Pain","2026-04-24",{"date":288,"type":289},"2026-04-29","ACTUAL",{"date":291,"type":289},"2018-12-13",{"date":293,"type":280},"2027-09-09",{"name":262,"class":6},13]