Clonazepam in Children Status Epilepticus
- Conditions
- Epilepticus Status
- Interventions
- Other: Efficacy of intravenous clonazepam
- Registration Number
- NCT04287361
- Lead Sponsor
- University Hospital, 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 310
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Loading dose ≥ 0,03 mg/kg Efficacy of intravenous clonazepam Patient being treated for a status epilepticus who received an initial dose of clonazepam ≥ 0.03 mg / kg Loading dose < 0,03 mg/kg Efficacy of intravenous clonazepam Patient being treated for a status epilepticus who received an initial dose of clonazepam \< 0.03 mg / kg
- Primary Outcome Measures
Name Time Method effectiveness in stopping seizures 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.
- Secondary Outcome Measures
Name Time Method duration of seizure 1 day duration of seizure (minutes)
type of seizures 1 day type of seizures (focal, generalized);
whether or not to use a dose greater than one milligram 1 day whether or not to use a dose greater than one milligram
aetiologies ; 1 day aetiologies (idiopathic, symptomatic)
using another antiepileptic drug 1 day using another antiepileptic drug (phenobarbital, fosphenytoin, thiopental)
Hospitalization in an intensive care or resuscitation unit 1 day Hospitalization in an intensive care or resuscitation unit
need for a second dose of clonazepam 1 day need for a second dose of clonazepam
pre-hospital treatment used 1 day pre-hospital treatment used
introduction of a maintenance dose 1 day introduction of a maintenance dose
Rate of hospitalization in conventional sector 1 day Rate of hospitalization in conventional sector
introduction of antiepileptic treatment after treatment 1 day introduction of antiepileptic treatment after treatment
Trial Locations
- Locations (1)
Uh Montpellier
🇫🇷Montpellier, France