Efficacy of ketamine in refractory convulsive status epilepticus in children: a multicenter, randomized, controlled, open-label, no-profit, with sequential design study.

Efficacy of ketamine in refractory convulsive status epilepticus in children: a multicenter, randomized, controlled, open-label, no-profit, with sequential design study. - KETASER01

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004396-12-IT

Enrollment

Registered

2014-01-31

Start date

2015-02-03

Completion date

Unknown

Last updated

2020-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory convulsive status epilepticus, defined as the recurrence of crisis for more than 60 minutes and / or drug-resistant I l and II line. MedDRA version: 17.1 Level: LLT Classification code 10057955 Term: Convulsive status epilepticus System Organ Class: 100000004852

Interventions

Trade Name: Ketamina Product Name: Ketamina Pharmaceutical Form: Solution for infusion Trade Name: Midazolam Product Name: Midazolam Pharmaceutical Form: Solution for infusion Trade Name: Propofol P

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients 1 month to 18 years old. 2) Diagnosis and clinical EEGrafica of refractory convulsive status epilepticus 3) Refractoriness of the drug I and II line 4) Written informed consent from parents or legal guardian. 5) 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. Are the trial subjects under 18? yes Number of subjects for this age range: 57 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1) contraindications to the use of the medication/s in the study. 2) pregnant or suspected pregnant.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of intravenous administration of KE in the treatment of refractory convulsive status epilepticus compared to administration of MDZ at high doses (TPS and / or PR).;Secondary Objective: To evaluate the efficacy of intravenous administration of KE in the treatment of refractory convulsive status epilepticus compared to administration of MDZ at high doses (TPS and / or PR).;Primary end point(s): Resolution of refractory convulsive status epilepticus;Timepoint(s) of evaluation of this end point: seven days	—

Measure

Time frame

Main Objective: To evaluate the efficacy of intravenous administration of KE in the treatment of refractory convulsive status epilepticus compared to administration of MDZ at high doses (TPS and / or PR).;Secondary Objective: To evaluate the efficacy of intravenous administration of KE in the treatment of refractory convulsive status epilepticus compared to administration of MDZ at high doses (TPS and / or PR).;Primary end point(s): Resolution of refractory convulsive status epilepticus;Timepoint(s) of evaluation of this end point: seven days

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Secondary

Measure	Time frame
Secondary end point(s): 1) Frequency of electro-medical crisis during treatment; 2) Frequency of crisis from outcome at hospital discharge; 3) Proportion of patients requiring intubation during treatment with KE; 4) Proportion of patients for whom it is necessary to support the use of cardiovascular drugs (amine) for heart failure secondary to ongoing therapy; 5) Proportion of subjects who respond to alternative therapy given after the registration of a therapeutic failure in the arm allocation; 6) Proportion of patients requiring discontinuation of study treatment for adverse events; 7) Proportion of treatment failures due to death (within 24 hours after discontinuation of therapy); 8) in-hospital mortality; 9) time to assisted ventilation;Timepoint(s) of evaluation of this end point: seven days	—

Measure

Time frame

Secondary end point(s): 1) Frequency of electro-medical crisis during treatment; 2) Frequency of crisis from outcome at hospital discharge; 3) Proportion of patients requiring intubation during treatment with KE; 4) Proportion of patients for whom it is necessary to support the use of cardiovascular drugs (amine) for heart failure secondary to ongoing therapy; 5) Proportion of subjects who respond to alternative therapy given after the registration of a therapeutic failure in the arm allocation; 6) Proportion of patients requiring discontinuation of study treatment for adverse events; 7) Proportion of treatment failures due to death (within 24 hours after discontinuation of therapy); 8) in-hospital mortality; 9) time to assisted ventilation;Timepoint(s) of evaluation of this end point: seven days

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Countries

Italy

Contacts

Public ContactDirigente medico

Anna Rosati

a.rosati@meyer.it00390555662573

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026