Ketamine in Refractory Convulsive Status Epilepticus

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02431663

Acronym

KETASER01

Enrollment

Registered

2015-05-01

Start date

2015-04-30

Completion date

2020-03-31

Last updated

2020-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Status Epilepticus

Keywords

refractory convulsive status epilepticus, ketamine, conventional anesthetics, children

Brief summary

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.

Interventions

DRUGKetamine

Intravenous administration in continuous

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Months to 18 Years

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.

Design outcomes

Primary

Measure	Time frame
Number of participants with resolution of refractory convulsive status epilepticus	participant wil be followed for 24 hours after discontinuation of study drug

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026