This double-blinded, randomized, placebo-controlled, parallel-arm pilot trial (n=20) will investigate the efficacy of intravenous ketamine for emergency department treatment of suicidal ideation (SI) in adolescents.
Approximately 20% of Canadian adolescents experience SI, and suicide ranks as the second leading cause of death among Canadians aged 15-19 years. Despite this, there are currently no fast-acting treatments available for SI in adolescents. Ketamine, known for its use in sedation, has shown efficacy in rapidly reducing SI in adults. However, its effectiveness in adolescents remains unstudied. The primary objective of this trial is to determine the feasibility of using intravenous ketamine to reduce SI in adolescents visiting the pediatric emergency department.
Participants, aged 12 to 17 years, who present with moderate to severe SI, will be enrolled. The study will involve two groups: one receiving intravenous ketamine and the other receiving a placebo. The study will assess the proportion of eligible participants who complete the study protocol, along with various secondary outcomes such as changes in suicidal ideation severity and safety measures.
If successful, this study could significantly impact the treatment of adolescent mental health emergencies and potentially reduce ED visits and admissions. The trial is being conducted at the Children’s Hospital of Eastern Ontario, with a projected completion date of September 2024.
Trial Details
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.NCT Number NCT06366334
Sponsors & Collaborators
Children's Hospital of Eastern OntarioCHEO is a pediatric health center in Ottawa, Canada, providing specialized care for young patients, including medical, surgical, mental health, & rehabilitation services.