Efficacy of ketamine in refractory convulsive status epilepticus in children: a protocol for a sequential design, multicentre, randomised, controlled, open-label, non-profit trial (KETASER01)
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Anna Rosati1, Lucrezia Ilvento1, Manuela L'Erario2
1Paediatric Neurology Unit, Meyer Children's Hospital, University of Florence, Florence, Italy.
Insights
This study investigates if ketamine (KE) is a safer and more effective treatment for refractory status epilepticus (RCSE) in children compared to traditional anesthetics. The research aims to provide evidence-based guidance for managing this critical neurological condition.
Area of Science:
- Neurology
- Pediatric Critical Care
- Pharmacology
Background:
- Refractory status epilepticus (RCSE) is a critical neurological emergency requiring intensive care.
- Current treatments for RCSE involve conventional anesthetics with limited evidence for optimal therapy.
- Ketamine (KE), an NMDA receptor antagonist, shows potential for treating RCSE.
Purpose of the Study:
- To compare the efficacy and safety of intravenous ketamine (KE) versus conventional anesthetics for treating RCSE in children.
- To establish evidence-based treatment guidelines for pediatric RCSE.
Main Methods:
- A multicenter, randomized, controlled, open-label study enrolling 57 pediatric patients (1 month to 18 years) with RCSE.
- Sequential design to assess the primary outcome: resolution of SE up to 24 hours post-therapy withdrawal.
- Comparison of KE efficacy and safety against conventional anesthetic agents.
Main Results:
- This is a pre-results abstract; study is ongoing.
- Primary outcome data on SE resolution will be analyzed sequentially.
- Efficacy and safety profiles of KE and conventional anesthetics are yet to be determined.
Conclusions:
- The study aims to provide critical evidence on ketamine's role in treating pediatric RCSE.
- Findings will inform clinical practice and treatment protocols for this life-threatening condition.
- Results will be disseminated through peer-reviewed publications and international conferences.
Introduction:
Status epilepticus (SE) is a life-threatening neurological emergency. SE lasting longer than 120 min and not responding to first-line and second-line antiepileptic drugs is defined as 'refractory' (RCSE) and requires intensive care unit treatment. There is currently neither evidence nor consensus to guide either the optimal choice of therapy or treatment goals for RCSE, which is generally treated with coma induction using conventional anaesthetics (high dose midazolam, thiopental and/or propofol). Increasing evidence indicates that ketamine (KE), a strong N-methyl-d-aspartate glutamate receptor antagonist, may be effective in treating RCSE. We hypothesised that intravenous KE is more efficacious and safer than conventional anaesthetics in treating RCSE.
Methods And Analysis:
A multicentre, randomised, controlled, open-label, non-profit, sequentially designed study will be conducted to assess the efficacy of KE compared with conventional anaesthetics in the treatment of RCSE in children. 10 Italian centres/hospitals are involved in enrolling 57 patients aged 1 month to 18 years with RCSE. Primary outcome is the resolution of SE up to 24 hours after withdrawal of therapy and is updated for each patient treated according to the sequential method.
Ethics And Dissemination:
The study received ethical approval from the Tuscan Paediatric Ethics Committee (12/2015). The results of this study will be published in peer-reviewed journals and presented at international conferences.
Trial Registration Number:
NCT02431663; Pre-results.
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