Clonazepam in Children Status Epilepticus (UHAPA)

Efficacy of Intravenous Clonazepam According to the Dosage 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.

Study Overview

• Status: Completed
• Conditions: Epilepticus Status
• Intervention / Treatment: Other: Efficacy of intravenous clonazepam

• Study Type: Observational
• Enrollment (Actual): 310

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • UH Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Loading dose < 0,03 mg/kg; Patient being treated for a status epilepticus who received an initial dose of clonazepam < 0.03 mg / kg	Other: Efficacy of intravenous clonazepam; Efficacy of intravenous clonazepam
Loading dose ≥ 0,03 mg/kg; Patient being treated for a status epilepticus who received an initial dose of clonazepam ≥ 0.03 mg / kg	Other: Efficacy of intravenous clonazepam; Efficacy of intravenous clonazepam

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
need for a second dose of clonazepam	need for a second dose of clonazepam	1 day
duration of seizure	duration of seizure (minutes)	1 day
type of seizures	type of seizures (focal, generalized);	1 day
aetiologies ;	aetiologies (idiopathic, symptomatic)	1 day
pre-hospital treatment used	pre-hospital treatment used	1 day
whether or not to use a dose greater than one milligram	whether or not to use a dose greater than one milligram	1 day
introduction of a maintenance dose	introduction of a maintenance dose	1 day
using another antiepileptic drug	using another antiepileptic drug (phenobarbital, fosphenytoin, thiopental)	1 day
Hospitalization in an intensive care or resuscitation unit	Hospitalization in an intensive care or resuscitation unit	1 day
Rate of hospitalization in conventional sector	Rate of hospitalization in conventional sector	1 day
introduction of antiepileptic treatment after treatment	introduction of antiepileptic treatment after treatment	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2019
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: February 11, 2020
• First Submitted That Met QC Criteria: February 26, 2020
• First Posted (Actual): February 27, 2020

Study Record Updates

• Last Update Posted (Actual): March 12, 2020
• Last Update Submitted That Met QC Criteria: March 10, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Seizures; Status Epilepticus; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; GABA Modulators; GABA Agents; Anticonvulsants; Clonazepam
• Other Study ID Numbers: RECHMPL19_0501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No