Clinical TrialSuicidalityKetaminePlaceboPlaceboTerminated

Ketamine Infusion for Rapid Reduction of Suicidality in Pediatrics (Keta4SI)

This Phase I/II interventional trial (n=96) will investigate the use of intravenous ketamine for the rapid reduction of suicidality in paediatric patients presenting with suicidal ideation (SI) in the emergency department (ED).

Target Enrollment
15 participants
Study Type
Phase I/II interventional
Design
Randomized, triple Blind

Detailed Description

This randomised, triple-blind, parallel-group pilot trial compares a single IV sub-anesthetic ketamine infusion (0.5 mg/kg, max 40 mg, 40 minutes) with midazolam active comparator and saline placebo in children aged 10–17 presenting to the paediatric ED with suicidal ideation.

Primary objective is to evaluate measurement instruments for suicidality and estimate sample size for a definitive trial; secondary objectives assess feasibility and optimise procedures. Safety monitoring follows adult ketamine experience but is tailored for paediatric ED setting.

Outcomes include acute changes in suicidality measures (C-SSRS variants), feasibility metrics, and adverse events collected during and after the ED visit.

Study Protocol

Preparation

sessions

Dosing

1 sessions
40 min each

Integration

sessions

Study Arms & Interventions

IV ketamine

experimental

Single IV infusion of ketamine 0.5 mg/kg (max 40 mg) over 40 minutes.

Interventions

  • Ketamine0.5 - 40 mg/kg
    via IV• single dose• 1 doses total

    Infused over 40 minutes; capped at 40 mg.

IV midazolam

active comparator

Single IV infusion of midazolam 0.03 mg/kg (max 2 mg) over 40 minutes as active comparator.

Interventions

  • Placebo0.03 mg/kg
    via IV• single dose• 1 doses total

    Midazolam 0.03 mg/kg, max 2 mg; infused over 40 minutes (active comparator; compound recorded as placeholder).

IV saline

inactive

0.9% saline placebo infusion over 40 minutes.

Interventions

  • Placebo
    via IV• single dose• 1 doses total

    0.9% normal saline infusion over 40 minutes.

Participants

Ages
10 – 17
Sexes
Male & Female

Inclusion Criteria

  • The study will enroll children and adolescents presenting with SI in the paediatric ED.
  • Inclusion Criteria:
  • 1. 10 to 17 years of age
  • 2. Respond "yes" to either question 1 (Passive Ideation) or 2 (Active Ideation) on the C-SSRS
  • 3. Respond "yes" to either questions 3 (Method), 4 (Intent), or 5 (Plan) on the C-SSRS
  • 4. Deemed acceptable and appropriate for admission to the on-site Child and Adolescent Psychiatry Emergency (CAPE) unit by a pediatric psychiatrist
  • 5. Successful completion of Capacity to Assent.
  • 6. Normal vital signs for age and a normal neurological exam (no focal deficits or abnormalities), as per attending clinician

Exclusion Criteria

  • Exclusion Criteria:
  • 1. History of benzodiazepine or ketamine use in the past 3 months (ample wash out period)
  • 2. Lifetime history of ketamine or benzodiazepine use disorder
  • 3. Previous diagnosis of schizophrenia or active psychosis as per the treating physician
  • 4. Lifetime history of schizoaffective disorder
  • 5. Current hypomania, mania, mixed state
  • 6. Clinically unstable, requires resuscitation or admission to a medical ward for stabilizing therapy (i.e., intensive care unit.)
  • 7. History of cerebrovascular accident, uncontrolled seizure disorder, increased intracranial pressure
  • 8. Uncontrolled hypertension, low or labile blood pressure, severe cardiac decompensation
  • 9. Moderate to severe hepatic/renal impairment
  • 10. Intoxicated or delirious
  • 11. Suspected or confirmed pregnancy or women who are breastfeeding
  • 12. Known allergy or sensitivity to ketamine and/or midazolam or any component in the formulation.
  • 13. Neuro-cognitive impairment that precludes informed consent, assent, or ability to self-report pain and satisfaction
  • 14. Inability to understand spoken and/or written English without the use of an interpreter
  • 15. Previous enrollment in this study
  • 16. No parent/guardian present.

Study Details

  • Status
    Terminated
  • Phase
    Phase IPhase II
  • Type
    interventional
  • Design
    Randomizedtriple Blind
  • Target Enrollment15 participants
  • Timeline
    Start: 2022-06-01
    End: 2024-12-01
  • Compounds
    KetaminePlaceboPlacebo
  • Topic
    Suicidality

Locations

BC Children's Hospital — Vancouver, British Columbia, Canada

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