Clonazepam in Children Status Epilepticus (UHAPA)

University Hospital Center (CHU)

Status: Completed

Conditions: Epilepticus Status

Treatments: Other: Efficacy of intravenous clonazepam

Study type: Observational

Funder types: Other

Identifiers

NCT04287361

RECHMPL19_0501

Details and patient eligibility

About

•Background: Intravenous clonazepam is the most widely used first-line benzodiazepine in Europe for the initial management of status epilepticus in children.

The guidelines of the "Société de reanimation de langue francaise" (SRLF) and the "société française de médecine d'urgence" (SFMU) published in 2018 recommend an initial loading dose of 0.015 mg / kg of clonazepam in this situation (maximum 1.5 mg).

To our knowledge, there is no specific study of the efficacy of clonazepam according to the dose used.

Objective: To compare the effectiveness of the initial loading dose of clonazepam in children treated for status epilepticus

•Methods: Monocentric retrospective study including children < 16 years who have benefited from an initial loading dose of clonazepam in the context of status epilepticus treated at the Montpellier University Hospital between January 2016 and June 2019.

The investigators collected data from medical records (clinic, treatment , evolution) and compared these according to the dosage of clonazepam used.

•Discussion: Among the benzodiazepines used in the first-line treatment of pediatric status epileptic, lorazepam and midazolam are the most widely used drugs in the world.

Lorazepam is not so much used in Europe because the injectable form is not available for a daily use. Conversely, clonazepam is used in a large number of European countries but is rarely used in the United States due to the lack of an injectable form.

About the tolerance of treatment, except overdose situations, clonazepam is a drug well tolerated in the pediatric populatin. The main side effects of clonazepam are respiratory depression and impaired alertness.

To our knowledge, this study is the first to examine the efficacy depending on the initial loading dosage of clonazepam in children status epilepticus.

Enrollment: 310 patients

Sex: All

Ages: Under 16 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

An individual must fulfill all of the following criteria in order to be eligible for study enrollment:

• Aged under 16 years
• Status epilepticus taken care of at the CHU de Montpellier

Exclusion criteria

● No loading dose of clonazepam

Trial design

310 participants in 2 patient groups

Loading dose < 0,03 mg/kg

Description:

Patient being treated for a status epilepticus who received an initial dose of clonazepam \< 0.03 mg / kg

Treatment:

Other: Efficacy of intravenous clonazepam

Loading dose ≥ 0,03 mg/kg

Description:

Patient being treated for a status epilepticus who received an initial dose of clonazepam ≥ 0.03 mg / kg

Treatment:

Other: Efficacy of intravenous clonazepam