Ketamine in Refractory Convulsive Status Epilepticus

Study Overview
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Brief Summary
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To evaluate the efficacy of intravenous administration of ketamine in the treatment of refractory convulsive status epilepticus in children compared to administration of midazolam at high doses, thiopental and / or propofol.

Official Title
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Efficacy of Ketamine in Refractory Convulsive Status Epilepticus in Children: a Multicenter, Randomized, Controlled, Open-label, No-profit, With Sequential Design Study.

Conditions
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Status Epilepticus

Intervention / Treatment
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* Drug: Ketamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis and clinical EEGrafica of refractory convulsive status epilepticus Refractoriness of the drug I and II line Written informed consent from parents or legal guardian. Administration of rating scales in the risk of mortality (PIM III) and severity of SE (stess, status epilepticusseverity score) to be performed prior to randomization. Exclusion Criteria: contraindications to the use of the medication/s in the study. pregnant or suspected pregnant.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ketamine up to 100 mcg/kg/min<br>Two intravenous boluses of 2-3 mg/kg each of ketamine will be administered 5 minutes apart and immediately followed by a continuous infusion of 5-10 mcg/kg/min. Based on both clinical or electrographic responses, dosage will be increased every 10 minutes or longer, using 2 to 10 mcg/kg/ min increments, up to 60 mcg/kg/min. Maximum duration of infusion will be of 7 days. | Drug: Ketamine<br>* Intravenous administration in continuous<br>* Other names: KETAMINA MOLTENI, vials of 2 ml (50 mg/ml);|
| Active Comparator: midazolam & thiopental & propofol<br>Midazolam intravenous will be increased every 5 minutes, using 2 mcg/kg/min increments, up to 12 mcg/kg/min and Thiopental intravenous will be increased every 30 minutes or longer, using 1 mg/kg/h increments, up to 6 mg/kg/h and Propofol intravenous will be increased every 5 minutes or longer, using 1 mg/kg/h increments, up to 5 mg/kg/h. Maximum duration of infusion for each drug will be 48 hours. | Drug: Ketamine<br>* Intravenous administration in continuous<br>* Other names: KETAMINA MOLTENI, vials of 2 ml (50 mg/ml);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with resolution of refractory convulsive status epilepticus |  | participant wil be followed for 24 hours after discontinuation of study drug | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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refractory convulsive status epilepticus, ketamine, conventional anesthetics, children