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
|