Clinical trial NCT04364321: Single Dose of Clonazepam Versus Intermiittent Diazepam for Febrile Seizures Prevention
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Recurrent Febrile Convulsion
Keywords: recurrent febrile convulsions
Clonazepam
prophylaxis
Lead sponsor: Queen Sirikit National Institute of Child Health
Sponsor class: OTHER_GOV
First posted: 2020-04-28
Enrollment: 74
Sex: ALL
Minimum age (years): 6
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A pragmatic parallel group randomized trial comparing single dose clonazepam with intermittent oral diazepam for prevention recurrent febrile seizures
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recurrent rate of febrile seizures
timeFrame: the assessment will be done at 12 months after enrollment
Secondary outcomes:
measure: Number of participants with adverse reaction of medications
timeFrame: 7 days
measure: Associated factors: Sex
timeFrame: at the enrollment.
measure: Associated factors: age at first febrile seizure
timeFrame: at the enrollment
measure: Associated factors: the lowest temperature that cause seizure
timeFrame: at the enrollment.
measure: Number of participants with febrile convulsions in parents or siblings
timeFrame: at the enrollment.
measure: Number of participants with epilepsy in parents or siblings
timeFrame: at the enrollment.
measure: Number of participants with type of febrile seizures (simple or complex)
timeFrame: at the enrollment.
measure: Number of participants with delayed developmental milestones
timeFrame: at the enrollment.
Other outcomes:
Locations:
city: Ratchathewi
country: Thailand
facility: Queen Sirikit National Institute of Child Health
state: Bangkok
Study officials:
affiliation: Queen Sirikit National Institute of Child Health
name: Jinjutha Nithiuthai, MD
role: PRINCIPAL_INVESTIGATOR
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