Ketamine in Refractory Convulsive Status Epilepticus

Ketamine

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.

Intervention / Treatment

  • Ketamine (DRUG)
    Intravenous administration in continuous

Condition or Disease

  • Status Epilepticus

Phase

  • Phase 3

    • Study Design

    Study type: INTERVENTIONAL
    Status: Terminated
    Study results: No Results Available
    Age: 1 Month to 18 Years
    Enrollment: 57 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    Clinical Trial Dates

    Start date: Apr 01, 2015
    Primary Completion: Mar 31, 2020 ACTUAL
    Completion Date: Mar 31, 2020 ACTUAL
    Study First Posted: May 01, 2015 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Oct 05, 2020

    Sponsors / Collaborators

    Lead Sponsor: N/A
    Responsible Party: N/A

    Location

    Florence, Tuscany, Italy

    Participant Groups

    • 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 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.

    Eligibility Criteria

    Sex: All
    Maximum Age: 18
    Age Groups: Child / Adult
    Healthy Volunteers: Yes

    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.

    Primary Outcomes
    • Number of participants with resolution of refractory convulsive status epilepticus participant wil be followed for 24 hours after discontinuation of study drug

    More Details

    NCT Number: NCT02431663
    Acronym: KETASER01
    Other IDs: EudraCT number: 2013-004396-12
    Study URL: https://clinicaltrials.gov/study/NCT02431663
    Last updated: Sep 29, 2023