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

Phase 1

• 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: 17.1Level: LLTClassification code 10057955Term: Convulsive status epilepticusSystem Organ Class: 100000004852; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2013-004396-12-IT
• Lead Sponsor: Azienda Ospedaliero-Universitaria Meyer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-31
• Last Update Posted: 23 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 57

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified