Ketamine Infusion for Rapid Reduction of Suicidality in Pediatrics
Status:
Not yet recruiting
Trial end date:
2023-11-01
Target enrollment:
Participant gender:
Summary
Suicide is a leading cause of death for children and adolescents. Since warning signs of
suicide and links to precipitating events differ between age groups, suicide can be difficult
to predict. As a result, children often seek care for suicidal ideation (SI) in the emergency
department (ED) where a limited number of treatment options exist. Current psychotherapies
and pharmacotherapies, such as antidepressants, provide benefit over weeks or months and thus
limits their effective application in the ED. Consequently, when there is an imminent threat
to the child's safety, the typical management solution is to admit the patient to a safe
environment and hopefully de-escalate over time. To address a more rapid-onset treatment
option for SI, a number of studies in adults have suggested that a single, sub-anesthetic
dose of intravenous ketamine can rapidly reduce depression and SI severity. These results are
promising, but large-scale trials are needed to determine if ketamine is a safe and effective
treatment for acute suicidality in the pediatric population. This approach has the benefit of
working rapidly, avoiding involuntary hospitalizations, and protecting patients from
self-harm until they can be connected to longer term mental health resources. This study will
compare the use of intravenous ketamine to both active and placebo controls in children 10 to
17 years of age presenting to the pediatric ED for SI. The primary objective of this pilot
trial is to explore the adequacy and range of three instruments measuring suicidality and to
determine the sample size required for a large definitive randomized control trial. This
larger trial will be used to estimate the effectiveness of intravenous ketamine for reducing
SI in children in the pediatric ED. The secondary objectives are to assess study feasibility
and optimize study procedures. Given very few side effects reported in adult studies and the
relatively benign nature of those reported, the investigators do not expect any major safety
concerns in the study.