Ketamine in Refractory Convulsive Status Epilepticus (KETASER01)

Meyer Children's Hospital IRCCS

Status and phase: Terminated; Phase 3

Conditions: Status Epilepticus

Treatments: Drug: Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT02431663

EudraCT number: 2013-004396-12

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 2 patient groups

ketamine up to 100 mcg/kg/min

Experimental group

Description:

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.

Treatment:

Drug: Ketamine

midazolam & thiopental & propofol

Active Comparator group

Description:

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.

Treatment:

Drug: Ketamine