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).
Details
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.