[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544242":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":64,"collaborators":30,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":30,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":30,"overallStatus":45,"whyStopped":30,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Children's Hospital of Eastern Ontario","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ketamine","EXPERIMENTAL","Participants in the intervention group will receive 0.5mg\u002Fkg of 1mg\u002FmL intravenous ketamine (50 mg maximum) over 40 minutes.",[13],"Drug: Ketamine Hydrochloride",{"label":15,"type":16,"description":17,"interventionNames":18},"Normal Saline","PLACEBO_COMPARATOR","Participants in the control group will receive 0.5mL\u002Fkg intravenous normal saline (50 ml maximum) over 40 minutes",[19],"Drug: Normal saline",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Ketamine Hydrochloride","See arm description",[9],[9],{"type":22,"name":28,"description":24,"armGroupLabels":29,"otherNames":30},"Normal saline",[15],null,[32],{"name":33,"affiliation":34,"role":35},"Tyrus Crawford, BA","CHEO","STUDY_DIRECTOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":30,"email":41},"Maala Bhatt, MD","CONTACT","6137377600","mbhatt@cheo.on.ca",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Children's Hospital Of Eastern Ontario","RECRUITING","Ottawa","Ontario","K1H 8L1","Canada","CA",{"type":52,"coordinates":53},"Point",[54,55],-75.69812,45.41117,{"lat":55,"lon":54},[58,61],{"name":59,"role":39,"phone":40,"phoneExt":60,"email":41},"Maala Bhatt, MD, MSc.","4178",{"name":62,"role":39,"phone":40,"phoneExt":60,"email":63},"Tyrus Crawford","tcrawford@cheo.on.ca",{"type":65,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","Maala Bhatt","Associate Professor of Pediatrics, Director of Emergency Research","100544242","study-of-iv-ketamine-for-emergency-department-treatment-of-adolescent-suicidal-ideation-100544242",false,"NCT06366334","Study of IV Ketamine for Emergency Department Treatment of Adolescent Suicidal Ideation","A Double Blinded, Randomized, Placebo Controlled, Parallel Arm Pilot Trial of Intravenous Ketamine for Emergency Department Treatment of Suicidal Ideation in a Pediatric Population.","KSI","Inclusion Criteria:\n\n1. Responds \"yes\" to Ask Suicide Screening Question (ASQ) #5 at triage, which asks; \"Are you having thoughts of killing yourself right now?\"\n2. Moderate to severe suicidal ideation, defined as score ≥ 3 on the first 5 questions of the Beck Scale for Suicidal Ideation (SSI5)\n3. Age 12 to 17 years, inclusive\n4. Medically clear (deemed fit for participation in the trial), as judged by the treating physician. Minimum criteria required to be deemed medically clear are: a) No evidence of serious physical injury requiring urgent intervention b) No evidence of acute ingestion requiring monitoring, blood tests, imaging or ECG or in the context of acute ingestion they have satisfied the requisite number of hours of post-ingestion monitoring with no further need for intervention.\n\nExclusion Criteria:\n\n1. Acute intoxication from any substance, including alcohol\n2. Previously enrolled in the current study or currently enrolled in another clinical trial\n3. History of intellectual disability or autism spectrum disorder by patient\u002Fparent report\n4. Active, or history of, psychosis or psychotic disorder\n5. History of non-psychiatric neurologic disorder (e.g., epilepsy)\n6. Any of the following contraindications to ketamine based on the drug monograph: a) Known allergy or hypersensitivity to ketamine by patient history b) History of cerebrovascular accident (stroke or aneurysm) c) History of elevated intracranial pressure or idiopathic intracranial hypertension d) Significant hypertension requiring daily medication e) Severe cardiac decompensation\n7. On an involuntary psychiatric hold\n8. Requires physical or chemical restraint\n9. History of violence while in hospital\n10. Pregnant or breastfeeding\n11. Received opioids in the 2-hours prior to study screening","ALL","12 Years","17 Years",{"count":80,"type":81},20,"ESTIMATED","INTERVENTIONAL",[84],"NA","Approximately 20% of Canadian adolescents experience thoughts of suicide, or suicidal ideation (SI), and suicide is the second leading cause of death among Canadians aged 15-19 years. The emergency department at CHEO sees approximately four patients per day with SI. Even though this is a medical emergency, there are no fast-acting treatments available.\n\nKetamine is a medication that is commonly used to safely sedate children who require painful procedures in the emergency department. For nearly ten years, intravenous ketamine has also been shown to rapidly reduce SI in adults. However, ketamine as a treatment for SI has never been studied in adolescents. The primary study objective is to pilot a clinical trial that investigates intravenous ketamine to emergently treat SI in adolescents.\n\nIf intravenous ketamine can relieve symptoms of SI for youth, this would have tremendous effects on patients and would dramatically change how physicians treat adolescent mental health emergencies. If ketamine is effective for several weeks, as it is in adults, it will help temporize patients until they receive more long-term psychiatric care. At the system level, it has the potential to reduce emergency visits and lengthy admissions. The investigators feel that the results of this study will be generalizable to pediatric centres across Canada and beyond.",[87,88],"Suicidal Ideation","Suicidal Ideas","2024-06-04",{"date":91,"type":92},"2024-06-05","ACTUAL",{"date":94,"type":92},"2024-01-15",{"date":96,"type":81},"2024-06-28",{"name":5,"class":6},1]