Single Dose of Clonazepam Versus Intermiittent Diazepam for Febrile Seizures Prevention

August 24, 2021 updated by: Kullasate Sakpichaisakul, Queen Sirikit National Institute of Child Health

The Efficacy of A Single Dose Clonazepam Compared With the Intermittent Diazepam to Prevent Recurrent Febrile Seizures in Queen Sirikit National Institute of Child Health

To study the efficacy and safety of single dose clonazepam compared with intermittent oral diazepam for prevention of recurrent febrile seizures in children who had three or more febrile seizures.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Febrile seizures are the most common type of seizures disorder of young children. The risk of recurrences are 33 percent overall, half of them had at least one recurrent seizure (the 3rd febrile seizures). After that the recurrent rate is 50-100 percent depend on their risk factors. A few studies found that multiple recurrent febrile seizures might associated with language developmental delayed, poor speed performance quotient, Attention deficit hyperactivity disorders. Moreover, seizures are upsetting both parents and children. During the febrile illness, the intermittent diazepam, continuous phenobarbital and valproate are effective for prevention of the recurrences. Because of the benign nature of a simple febrile seizures, the risks of side effects generally outweigh the benefits. However, there is no clinical guidelines for prevention of recurrent febrile seizures in the children who experienced multiple occurrences. The better prophylactic drug; safe, effective and easy to use, for prevention of recurrent febrile seizures in children with multiple recurrences might be needed. Clonazepam, the long half-life benzodiazepine, is commonly used for treatment of epilepsy may be effective in preventing recurrent febrile seizures. This study, a single-blind, randomized clinical trial, single dose clonazepam at the time of fever present compared with oral diazepam during the fever to prevent the recurrent febrile seizures.

Study Type

Interventional

Enrollment (Anticipated)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Thailand
    • Bangkok
      • Ratchathewi, Bangkok, Thailand, 10400
        • Recruiting
        • Queen Sirikit National Institute of Child Health
        • Sub-Investigator:
          • Somjit Sri-udomkajorn, MD
        • Sub-Investigator:
          • Sirorat Suwannachote, MD
        • Contact:
        • Principal Investigator:
          • Jinjutha Nitiuthai, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 months to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 6-60 months at date of enrollment
  • 3 or more episodes of clinically diagnosed febrile seizures

Exclusion Criteria:

  • history of afebrile seizures or any history suggested the epilepsy
  • history of previous brain insults; CNS infection, birth trauma, traumatic brain injury.
  • delayed developmental milestones
  • abnormal neurological examinations
  • currently treatment by continous antiepileptic drug(s)
  • A contraindication to Clonazepam, Diazepam such as drug hypersensitivity, liver disease.
  • Predictable lack of available of follow up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single dose Clonazepam
Clonazepam(0.5 mg/tablet) 0.02 mg/kg orally once at the time of fever present. (body temperature more than 38 degree Celsius)
Drug: Clonazepam 0.5 MG
Clonazepam 0.02 mg/kg only one dose
Other Names:
  • Rivotril
  • Povanil
Active Comparator: Intermittent oral diazepam
Diazepam 0.3 mg/kg every 8 hours for 3 doses. (24 hr) start at the time of body temperature more than 38 degree Celsius.
Drug: Diazepam Tablets
Diazepam 0.3 mg/kg every 8 hours for 3 doses. (24 hr)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrent rate of febrile seizures
Time Frame: the assessment will be done at 12 months after enrollment
Rate of seizure occurs when the children have febrile illnesses (at the onset of fever until fever gone). The seizures will be reported by their parents/caregivers. (via the seizure record form and the interview.) Statistic analysis: Cumulative incidence (person-year). percent. Comparison between the two group by unpaired t test.
the assessment will be done at 12 months after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse reaction of medications
Time Frame: 7 days

The adverse reactions will be recorded by their caregivers in the record form for 7 days since patients taking the medication (clonapam or diazepam).

The adverse reactions are drowsiness, ataxia, irritability, drooling, insomnia and rashes.

Statistic analysis: cumulative incidence (person-year), Comparison between the two group by unpaired t test.
7 days
Associated factors: Sex
Time Frame: at the enrollment.

To evaluate the associated factors of multiple recurrent febrile seizures.

The data will be collected in the record form by the primary investigator at the enrollment.

Statistic analysis: comparison between group by chi square
at the enrollment.
Associated factors: age at first febrile seizure
Time Frame: at the enrollment

To evaluate the associated factors of multiple recurrent febrile seizures.

The data will be collected in the record form by interviewing the caregivers to recall the information.

Statistic analysis: comparison between group by unpaired t test
at the enrollment
Associated factors: the lowest temperature that cause seizure
Time Frame: at the enrollment.

To evaluate the associated factors of multiple recurrent febrile seizures.

The data will be collected in the record form by interviewing the caregivers to recall the information.

Statistic analysis: comparison between group by unpaired t test
at the enrollment.
Number of participants with febrile convulsions in parents or siblings
Time Frame: at the enrollment.

To evaluate the associated factors of multiple recurrent febrile seizures.

The data will be collected in the record form by interviewing the caregivers.

Statistic analysis: comparison between group by chi square
at the enrollment.
Number of participants with epilepsy in parents or siblings
Time Frame: at the enrollment.

To evaluate the associated factors of multiple recurrent febrile seizures.

The data will be collected in the record form by interviewing the caregivers.

Statistic analysis: comparison between group by chi square
at the enrollment.
Number of participants with type of febrile seizures (simple or complex)
Time Frame: at the enrollment.

To evaluate the associated factors of multiple recurrent febrile seizures.

Type of febrile seizure

  1. simple: seizure duration less than 15 min, generalized seizures, one seizure in 24 hours
  2. complex:15 minutes or more and/or focal seizures and/or 2 or more seizures in 24 hours

The data will be collected in the record form by interviewing the caregivers.

Statistic analysis: comparison between group by chi square
at the enrollment.
Number of participants with delayed developmental milestones
Time Frame: at the enrollment.

The data will be collected by the developmental screening tools; Age and Stages Questionaires, third edition reported by the caregivers. Scoring will be done by neurology pediatrician at the enrollment.

Age and Stages Questionaires(third editon) are divided in 5 areas; communication, gross motor, fine motor, problem solving, personal-social, each area has 6 questions. Scores for each area are between 0 to 60. The Cutoff points are different in each area. If the score is above the cutoff, the children development appears normal for age.

(The cutoff for communication is 29.65, Gross motor is 22.25, fine motor is 25.14, problem solving is 27.72 and personal-social is 25.34)

Statistic analysis: comparison between group by unpaired t test
at the enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Sirikit National Institute of Child Health

Investigators

  • Principal Investigator: Jinjutha Nithiuthai, MD, Queen Sirikit National Institute of Child Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2020

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

April 5, 2020

First Submitted That Met QC Criteria

April 26, 2020

First Posted (Actual)

April 28, 2020

Study Record Updates

Last Update Posted (Actual)

August 30, 2021

Last Update Submitted That Met QC Criteria

August 24, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QSNICH63-017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is no plan to make IPD available due to the confidentiality.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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