Ketamine in Refractory Convulsive Status Epilepticus

Phase 3TerminatedNCT02431663

Meyer Children's Hospital IRCCS57 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Status Epilepticus

Interventions

KetamineDRUG

Intravenous administration in continuous

Eligibility

Sex: ALLMin age: 1 MonthMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Anna Rosati

Florence, Italy

Outcomes

Primary Outcomes

Number of participants with resolution of refractory convulsive status epilepticus

Time frame: participant wil be followed for 24 hours after discontinuation of study drug

Data from ClinicalTrials.gov

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