Ketamine in Refractory Convulsive Status Epilepticus

• Status: Terminated
• Trial end date: 2020-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Meyer Children's Hospital
• Collaborators: 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 Azienda Ospedaliero-Universitaria di Bologna; IRCCS Burlo Garofolo; Nuovo Regina Margherita Hospital; Ospedali Riuniti Ancona; University of Padova; Vittore Buzzi Children's Hospital
• Treatments: Ketamine; Thiopental

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.