Uh Montpellier
Montpellier, 34295, France
NCT Number: NCT04287361
•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.
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Notify MeUp to 16 year
All sexes
Observational
Montpellier, 34295, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
An individual must fulfill all of the following criteria in order to be eligible for study enrollment:
Exclusion criteria
● No loading dose of clonazepam
Efficacy of intravenous clonazepam
Time frame: 1 day
The primary endpoint was clinical cessation of seizures, which was defined as the absence of clinical signs of seizures immediately following the injection of clonazepam.
Time frame: 1 day
need for a second dose of clonazepam
Time frame: 1 day
duration of seizure (minutes)
Time frame: 1 day
type of seizures (focal, generalized);
Time frame: 1 day
aetiologies (idiopathic, symptomatic)
Time frame: 1 day
pre-hospital treatment used
Time frame: 1 day
whether or not to use a dose greater than one milligram
Time frame: 1 day
introduction of a maintenance dose
Time frame: 1 day
using another antiepileptic drug (phenobarbital, fosphenytoin, thiopental)
Time frame: 1 day
Hospitalization in an intensive care or resuscitation unit
Time frame: 1 day
Rate of hospitalization in conventional sector
Time frame: 1 day
introduction of antiepileptic treatment after treatment
University Hospital, Montpellier
Other
Efficacy of Intravenous Clonazepam According to the Dosage in Children Status Epilepticus
Acronym: UHAPA
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