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Completed

NCT Number: NCT04287361

Clonazepam in Children Status Epilepticus

•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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Key information

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Uh Montpellier

Montpellier, 34295, France

Who can participate

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:

  • Aged under 16 years
  • Status epilepticus taken care of at the CHU de Montpellier

Exclusion criteria

● No loading dose of clonazepam

Treatment and study plan

Efficacy of intravenous clonazepam

Other

Efficacy of intravenous clonazepam

Primary outcomes

  1. effectiveness in stopping seizures

    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.

Secondary outcomes

  1. need for a second dose of clonazepam

    Time frame: 1 day

    need for a second dose of clonazepam

  2. duration of seizure

    Time frame: 1 day

    duration of seizure (minutes)

  3. type of seizures

    Time frame: 1 day

    type of seizures (focal, generalized);

  4. aetiologies ;

    Time frame: 1 day

    aetiologies (idiopathic, symptomatic)

  5. pre-hospital treatment used

    Time frame: 1 day

    pre-hospital treatment used

  6. whether or not to use a dose greater than one milligram

    Time frame: 1 day

    whether or not to use a dose greater than one milligram

  7. introduction of a maintenance dose

    Time frame: 1 day

    introduction of a maintenance dose

  8. using another antiepileptic drug

    Time frame: 1 day

    using another antiepileptic drug (phenobarbital, fosphenytoin, thiopental)

  9. Hospitalization in an intensive care or resuscitation unit

    Time frame: 1 day

    Hospitalization in an intensive care or resuscitation unit

  10. Rate of hospitalization in conventional sector

    Time frame: 1 day

    Rate of hospitalization in conventional sector

  11. introduction of antiepileptic treatment after treatment

    Time frame: 1 day

    introduction of antiepileptic treatment after treatment

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: UHAPA

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 27, 2020
Registry last updated
Mar 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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