NCT04955470

Ketamine Infusion for Rapid Reduction of Suicidality in Pediatrics

Ketamine Infusion for Rapid Reduction of Suicidality in Pediatrics: a Pilot Randomized Controlled Trial

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Suicidal Ideation

Interventions

Type	Name	Description
DRUG	Ketamine Injectable Solution	A 10 mg/mL solution of ketamine will be infused over a 40 minute period at a dose of 0.05mg/kg.
DRUG	Midazolam Injectable Solution	A 5 mg/mL solution of midazolam will be infused over a 40 minute period at a dose of 0.02 mg/kg.
DRUG	Normal Saline 0.9% Injectable Solution	A 0.9% normal saline solution will be infused over a 40 minute period.

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-09-01
• Completion: 2023-10-01
• First posted: 2021-07-08
• Last updated: 2024-12-18

Locations

1 site across 1 country: Canada