At a glance
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Efficacy of Combined Ketamine and Midazolam for Treatment of Generalized Convulsive Status Epilepticus in Children .
In Brief
A Phase 3 clinical trial evaluating Ketamine, Midazolam, and 1 other intervention for Generalized Convulsive Status Epilepticus. Completed, enrolled 144 participants across 1 site.
Detailed Summary
Generalized convulsive status epilepticus (GCSE) is a common neurological emergency in children. Benzodiazepines are the recommended first line antiseizure medication (ASMs), but they fail to control seizures in a third of cases. Combination of benzodiazepines with another ASM that has a different mechanism of action may be a promising option for faster control of GCSE. In this study, the investigators aim to evaluate the efficacy and safety of ketamine plus midazolam versus midazolam alone as first-line therapy of pediatric GCSE.
Study Details
Timeline
Interventions
Intravenous ketamine 2 mg/kg (max 60 mg) over 2 minutes (diluted with isotonic saline to 5 mg/ml concentration)
Intravenous midazolam 0.2 mg/kg (maximum 10 mg) over 2 minutes
Intravenous isotonic saline 0.4 ml/kg (max 12 ml) over 5 minutes