Efficacy of Ketamine in Refractory Convulsive Status Epilepticus in Children: a Multicenter, Randomized, Controlled, Open-label, No-profit, With Sequential Design Study.
| Registry | NCT02431663, acronym KETASER01 |
|---|---|
| Status | Terminated - Futility |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 57 (Actual) |
| Sponsor | Meyer Children's Hospital IRCCS (Other); collaborators: Ospedali Riuniti Ancona, IRCCS Azienda Ospedaliero-Universitaria di Bologna, University of Padova, Bambino Gesù Hospital and Research Institute, Catholic University of the Sacred Heart, IRCCS Burlo Garofolo, Azienda Ospedaliera Universitaria Integrata Verona, Nuovo Regina Margherita Hospital, Vittore Buzzi Children's Hospital |
| Conditions | Status Epilepticus |
| Interventions | Ketamine (Drug) |
| Dates | start 2015-04-01, primary completion 2020-03-31, completion 2020-03-31, first posted 2015-05-01, last updated 2020-10-08 |
| Locations | 1 site in Italy |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| ketamine up to 100 mcg/kg/min | Experimental | Drug: Ketamine | Two intravenous boluses of 2-3 mg/kg each of ketamine will be administered 5 minutes apart and immediately followed by a continuous infusion of 5-10 mcg/kg/min. Based on both clinical or electrographic responses, dosage will be increased every 10 minutes or longer, using 2 to 10 mcg/kg/ min increments, up to 60 mcg/kg/min. Maximum duration of infusion will be of 7 days. |
| midazolam & thiopental & propofol | Active comparator | Drug: Ketamine | Midazolam intravenous will be increased every 5 minutes, using 2 mcg/kg/min increments, up to 12 mcg/kg/min and Thiopental intravenous will be increased every 30 minutes or longer, using 1 mg/kg/h increments, up to 6 mg/kg/h and Propofol intravenous will be increased every 5 minutes or longer, using 1 mg/kg/h increments, up to 5 mg/kg/h. Maximum duration of infusion for each drug will be 48 hours. |
Sex: All, ages: 1 Month to 18 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Anna Rosati | Florence | Italy |