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Clonazepam in Children Status Epilepticus

Efficacy of Intravenous Clonazepam According to the Dosage in Children Status Epilepticus

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04287361
Acronym
UHAPA
Enrollment
310
Registered
2020-02-27
Start date
2019-08-30
Completion date
2020-01-31
Last updated
2020-03-12

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

Conditions

Epilepticus Status

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.

Interventions

OTHEREfficacy of intravenous clonazepam

Efficacy of intravenous clonazepam

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 16 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
effectiveness in stopping seizures1 dayThe primary endpoint was clinical cessation of seizures, which was defined as the absence of clinical signs of seizures immediately following the injection of clonazepam.

Secondary

MeasureTime frameDescription
duration of seizure1 dayduration of seizure (minutes)
type of seizures1 daytype of seizures (focal, generalized);
aetiologies ;1 dayaetiologies (idiopathic, symptomatic)
pre-hospital treatment used1 daypre-hospital treatment used
whether or not to use a dose greater than one milligram1 daywhether or not to use a dose greater than one milligram
need for a second dose of clonazepam1 dayneed for a second dose of clonazepam
using another antiepileptic drug1 dayusing another antiepileptic drug (phenobarbital, fosphenytoin, thiopental)
Hospitalization in an intensive care or resuscitation unit1 dayHospitalization in an intensive care or resuscitation unit
Rate of hospitalization in conventional sector1 dayRate of hospitalization in conventional sector
introduction of antiepileptic treatment after treatment1 dayintroduction of antiepileptic treatment after treatment
introduction of a maintenance dose1 dayintroduction of a maintenance dose

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026