Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06366334
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-04-10
Brief Title:
Study of IV Ketamine for Emergency Department Treatment of Adolescent Suicidal Ideation
Sponsor:
Childrens Hospital of Eastern Ontario
Organization:
Childrens Hospital of Eastern Ontario
Study Overview
Official Title:
A Double Blinded Randomized Placebo Controlled Parallel Arm Pilot Trial of Intravenous Ketamine for Emergency Department Treatment of Suicidal Ideation in a Pediatric Population
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KSI
Brief Summary:
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
Ketamine 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
If 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
Ketamine 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
If 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
Detailed Description:
Suicidal ideation SI is a common and often severe cause of morbidity in adolescents Patients frequently present to the emergency department ED with severe and distressing thoughts of self-harm or suicide and yet there is currently no acute therapeutic intervention to offer them The standard of care for patients who do not require admission is to discharge them home with resources for websites apps or telephone help lines These interactions fail to address the underlying suicidal thoughts and leave patients families and providers feeling very dissatisfied Medications are nearly never initiated in the ED and patients who are already taking anti-depressants experience a very slow therapeutic onset and often with unfavourable side effects that make medication compliance difficult and sometimes impossible
For nearly ten years intravenous ketamine has been shown to be an efficacious acute therapy in adult patients with suicidal ideation A single dose of intravenous IV ketamine can rapidly reduce the severity of suicidal ideation by moderate to large effect sizes Cohens d 05-08 during an ED visit in an adult population However it has never been studied in a pediatric population The study primary objective is to determine the feasibility of conducting a trial that investigates the efficacy of IV ketamine to reduce suicidal ideation in adolescents in the pediatric emergency department
If intravenous ketamine can rapidly alleviate the severity of SI for adolescents this would have tremendous effects on patients and families and dramatically change how ED physicians treat pediatric mental health emergencies It would increase patient safety reduce patient distress morbidity possibly mortality and alleviate family stress If the therapeutic effect of ketamine is maintained for several days as it is in adults it will help temporize patient symptoms while they are connected with more long-term psychiatric care At the system level it may reduce rates of ED visits and often lengthy admissions to hospital The investigators feel that the results of this study will be generalizable to pediatric centres across Ontario Canada and beyond
For nearly ten years intravenous ketamine has been shown to be an efficacious acute therapy in adult patients with suicidal ideation A single dose of intravenous IV ketamine can rapidly reduce the severity of suicidal ideation by moderate to large effect sizes Cohens d 05-08 during an ED visit in an adult population However it has never been studied in a pediatric population The study primary objective is to determine the feasibility of conducting a trial that investigates the efficacy of IV ketamine to reduce suicidal ideation in adolescents in the pediatric emergency department
If intravenous ketamine can rapidly alleviate the severity of SI for adolescents this would have tremendous effects on patients and families and dramatically change how ED physicians treat pediatric mental health emergencies It would increase patient safety reduce patient distress morbidity possibly mortality and alleviate family stress If the therapeutic effect of ketamine is maintained for several days as it is in adults it will help temporize patient symptoms while they are connected with more long-term psychiatric care At the system level it may reduce rates of ED visits and often lengthy admissions to hospital The investigators feel that the results of this study will be generalizable to pediatric centres across Ontario Canada and beyond
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None