Ketamine in Refractory Convulsive Status Epilepticus

Phase 3

Terminated

• Conditions: Status Epilepticus
• Interventions: Drug: Ketamine

• Registration Number: NCT02431663
• Lead Sponsor: Meyer Children's Hospital IRCCS

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-03
• Study First Submitted QC: 2015-04-27
• Study First Posted: 2015-05-01
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-05
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 57

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ketamine up to 100 mcg/kg/min	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	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.

Primary Outcome Measures

Name	Time	Method
Number of participants with resolution of refractory convulsive status epilepticus	participant wil be followed for 24 hours after discontinuation of study drug

Trial Locations

Locations (1)

Anna Rosati; 🇮🇹 Firenze, Italy