Single Dose of Clonazepam Versus Intermiittent Diazepam for Febrile Seizures Prevention

Queen Sirikit National Institute of Child Health

Status: Unknown

Conditions: Recurrent Febrile Convulsion

Treatments: Drug: Diazepam Tablets; Drug: Clonazepam 0.5 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT04364321

QSNICH63-017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 estimated patients

Sex: All

Ages: 6 to 60 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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74 participants in 2 patient groups

Single dose Clonazepam

Experimental group

Description:

Clonazepam(0.5 mg/tablet) 0.02 mg/kg orally once at the time of fever present. (body temperature more than 38 degree Celsius)

Treatment:

Drug: Clonazepam 0.5 MG

Intermittent oral diazepam

Active Comparator group

Description:

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.

Treatment:

Drug: Diazepam Tablets