Recruiting

Ketamine

Sponsor:

Children's Hospital of Eastern Ontario

Code:

NCT06366334

Conditions

Suicidal Ideation

Suicidal Ideas

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Interventions

Ketamine Hydrochloride

Normal saline

Study Details

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.

Conditions

Suicidal Ideation

Suicidal Ideas

Study ID

NCT06366334

Start date

Jan 15, 2024

Status verified date

Jun, 2024

Completion date

Jun 28, 2024

Anticipated

Primary completion date

May 29, 2024

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Responds "yes" to Ask Suicide Screening Question (ASQ) #5 at triage, which asks; "Are you having thoughts of killing yourself right now?"
2. Moderate to severe suicidal ideation, defined as score ≥ 3 on the first 5 questions of the Beck Scale for Suicidal Ideation (SSI5)
3. Age 12 to 17 years, inclusive
4. 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.

Exclusion Criteria:

1. Acute intoxication from any substance, including alcohol
2. Previously enrolled in the current study or currently enrolled in another clinical trial
3. History of intellectual disability or autism spectrum disorder by patient/parent report
4. Active, or history of, psychosis or psychotic disorder
5. History of non-psychiatric neurologic disorder (e.g., epilepsy)
6. 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
7. On an involuntary psychiatric hold
8. Requires physical or chemical restraint
9. History of violence while in hospital
10. Pregnant or breastfeeding
11. Received opioids in the 2-hours prior to study screening

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ketamine

Participants in the intervention group will receive 0.5mg/kg of 1mg/mL intravenous ketamine (50 mg maximum) over 40 minutes.

placebo comparator: Normal Saline

Participants in the control group will receive 0.5mL/kg intravenous normal saline (50 ml maximum) over 40 minutes

Interventions

Ketamine Hydrochloride

See arm description

Normal saline

See arm description

Primary outcome measure

  • Proportion of eligible participants who complete the study protocol [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Locations

Children's Hospital Of Eastern Ontario

Recruiting

Ottawa, Ontario, Canada, K1H 8L1

Contacts

More Information

Sponsor

Children's Hospital of Eastern Ontario

Last update posted

Jun 5, 2024

Last verified

Jun, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Children's Hospital of Eastern Ontario on 2024-06-05.