TerminatedPhase 3

Ketamine in Refractory Convulsive Status Epilepticus

Stopped: Futility

Italy57 participantsStarted 2015-04

Plain-language 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.

Who can participate

Age range1 Month – 18 Years

SexALL

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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.

What they're measuring

Number of participants with resolution of refractory convulsive status epilepticus

Timeframe: participant wil be followed for 24 hours after discontinuation of study drug

Trial details

NCT IDNCT02431663

SponsorMeyer Children's Hospital IRCCS

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-03-31

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