Single Dose of Clonazepam Versus Intermiittent Diazepam for Febrile Seizures Prevention

Last updated: August 24, 2021
Sponsor: Queen Sirikit National Institute of Child Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

Fever

Seizure Disorders

Treatment

N/A

Clinical Study ID

NCT04364321
QSNICH63-017
  • Ages 6-60
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 74
Study Start date:
May 13, 2020
Estimated Completion Date:
June 30, 2023

Study 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.

Connect with a study center

  • Queen Sirikit National Institute of Child Health

    Ratchathewi, Bangkok 10400
    Thailand

    Active - Recruiting

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