NCT04364321

Single Dose of Clonazepam Versus Intermiittent Diazepam for Febrile Seizures Prevention

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Queen Sirikit National Institute of Child Health · Other Government
• Sex: All
• Age: 6 Months – 60 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent Febrile Convulsion

Interventions

Type	Name	Description
DRUG	Clonazepam 0.5 MG	Clonazepam 0.02 mg/kg only one dose
DRUG	Diazepam Tablets	Diazepam 0.3 mg/kg every 8 hours for 3 doses. (24 hr)

Timeline

• Start date: 2020-05-13
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2020-04-28
• Last updated: 2021-08-30

Locations

1 site across 1 country: Thailand