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Ketamine in Refractory Convulsive Status Epilepticus

Information source: Meyer Children's Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Status Epilepticus

Intervention: Ketamine (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Meyer Children's Hospital

Official(s) and/or principal investigator(s):
Anna Rosati, MD, PhD, Study Chair, Affiliation: Children's Hospital A. Meyer of Firenze, Italy

Overall contact:
Anna Rosati, MD, PhD, Phone: 0555662573, Ext: 0039, Email: a.rosati@meyer.it

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of participants with resolution of refractory convulsive status epilepticus

Eligibility

Minimum age: 1 Month. Maximum age: 18 Years. Gender(s): Both.

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.

Locations and Contacts

Anna Rosati, MD, PhD, Phone: 0555662573, Ext: 0039, Email: a.rosati@meyer.it

Anna Rosati, Firenze 50139, Italy; Recruiting
Anna Rosati, MD, PhD, Phone: 0555662573, Ext: 0039, Email: a.rosati@meyer.it
Additional Information

Starting date: April 2015
Last updated: May 4, 2015

Page last updated: August 23, 2015

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