Clinical trial NCT04287361: Clonazepam in Children Status Epilepticus
Official title: Efficacy of Intravenous Clonazepam According to the Dosage in Children Status Epilepticus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepticus Status
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-02-27
Enrollment: 310
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief summary: •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.


Eligibility 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

Primary outcomes:
measure: effectiveness in stopping seizures
timeFrame: 1 day
Secondary outcomes:
measure: need for a second dose of clonazepam
timeFrame: 1 day
measure: duration of seizure
timeFrame: 1 day
measure: type of seizures
timeFrame: 1 day
measure: aetiologies ;
timeFrame: 1 day
measure: pre-hospital treatment used
timeFrame: 1 day
measure: whether or not to use a dose greater than one milligram
timeFrame: 1 day
measure: introduction of a maintenance dose
timeFrame: 1 day
measure: using another antiepileptic drug
timeFrame: 1 day
measure: Hospitalization in an intensive care or resuscitation unit
timeFrame: 1 day
measure: Rate of hospitalization in conventional sector
timeFrame: 1 day
measure: introduction of antiepileptic treatment after treatment
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: University Hospitals of Montpellier
name: Maxime colmard, résident
role: PRINCIPAL_INVESTIGATOR
References: