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).
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.
Single IV infusion of ketamine 0.5 mg/kg (max 40 mg) over 40 minutes.
Infused over 40 minutes; capped at 40 mg.
Single IV infusion of midazolam 0.03 mg/kg (max 2 mg) over 40 minutes as active comparator.
Midazolam 0.03 mg/kg, max 2 mg; infused over 40 minutes (active comparator; compound recorded as placeholder).
0.9% saline placebo infusion over 40 minutes.
0.9% normal saline infusion over 40 minutes.