Ketamine in Refractory Convulsive Status Epilepticus (KETASER01)
Status Epilepticus
About this trial
This is an interventional treatment trial for Status Epilepticus focused on measuring refractory convulsive status epilepticus, ketamine, conventional anesthetics, children
Eligibility Criteria
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.
Sites / Locations
- Anna Rosati
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
ketamine up to 100 mcg/kg/min
midazolam & thiopental & propofol
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.
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.