Epilepticus Status Clinical Trial
— UHAPAOfficial title:
Efficacy of Intravenous Clonazepam According to the Dosage in Children Status Epilepticus
| Verified date | March 2020 |
| Source | University Hospital, Montpellier |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
•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.
| Status | Completed |
| Enrollment | 310 |
| Est. completion date | January 31, 2020 |
| Est. primary completion date | January 1, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 16 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Uh Montpellier | Montpellier |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Montpellier |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | effectiveness in stopping seizures | 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. | 1 day | |
| Secondary | need for a second dose of clonazepam | need for a second dose of clonazepam | 1 day | |
| Secondary | duration of seizure | duration of seizure (minutes) | 1 day | |
| Secondary | type of seizures | type of seizures (focal, generalized); | 1 day | |
| Secondary | aetiologies ; | aetiologies (idiopathic, symptomatic) | 1 day | |
| Secondary | pre-hospital treatment used | pre-hospital treatment used | 1 day | |
| Secondary | whether or not to use a dose greater than one milligram | whether or not to use a dose greater than one milligram | 1 day | |
| Secondary | introduction of a maintenance dose | introduction of a maintenance dose | 1 day | |
| Secondary | using another antiepileptic drug | using another antiepileptic drug (phenobarbital, fosphenytoin, thiopental) | 1 day | |
| Secondary | Hospitalization in an intensive care or resuscitation unit | Hospitalization in an intensive care or resuscitation unit | 1 day | |
| Secondary | Rate of hospitalization in conventional sector | Rate of hospitalization in conventional sector | 1 day | |
| Secondary | introduction of antiepileptic treatment after treatment | introduction of antiepileptic treatment after treatment | 1 day |