Ketamine in Refractory Convulsive Status Epilepticus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2020-03-31

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.

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Detailed Description

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Conditions

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Status Epilepticus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ketamine up to 100 mcg/kg/min

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.

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

Intravenous administration in continuous

midazolam & thiopental & propofol

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.

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

Intravenous administration in continuous

Interventions

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Ketamine

Intravenous administration in continuous

Intervention Type DRUG

Other Intervention Names

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KETAMINA MOLTENI, vials of 2 ml (50 mg/ml)

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.