Ketamine in Refractory Convulsive Status Epilepticus

Status Epilepticus Clinical Trial

— KETASER01  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02431663
• Other study ID #: EudraCT number: 2013-004396-12
• Status: Terminated
• Phase: Phase 3
• Start date: April 2015
• Est. completion date: March 31, 2020

Study information

• Verified date: October 2020
• Source: Meyer Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 57
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Status Epilepticus

Intervention

Drug:
• Ketamine
Intravenous administration in continuous

Locations

Country	Name	City	State
Italy	Anna Rosati	Firenze

Sponsors (10)

Lead Sponsor	Collaborator
Meyer Children's Hospital	Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi, Azienda Ospedaliera Universitaria Integrata Verona, Bambino Gesù Hospital and Research Institute, Catholic University of the Sacred Heart, IRCCS Burlo Garofolo, Nuovo Regina Margherita Hospital, Ospedali Riuniti Ancona, University of Padova, Vittore Buzzi Children's Hospital

Country where clinical trial is conducted

Italy, 

Outcome

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