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

Sponsors

Lead Sponsor: Queen Sirikit National Institute of Child Health

Source Queen Sirikit National Institute of Child Health
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.

Overall Status Not yet recruiting
Start Date 2020-05-01
Completion Date 2021-06-30
Primary Completion Date 2021-04-30
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Recurrent rate of febrile seizures the assessment will be done at 12 months after enrollment
Secondary Outcome
Measure Time Frame
Number of participants with adverse reaction of medications 7 days
Associated factors: Sex at the enrollment.
Associated factors: age at first febrile seizure at the enrollment
Associated factors: the lowest temperature that cause seizure at the enrollment.
Number of participants with febrile convulsions in parents or siblings at the enrollment.
Number of participants with epilepsy in parents or siblings at the enrollment.
Number of participants with type of febrile seizures (simple or complex) at the enrollment.
Number of participants with delayed developmental milestones at the enrollment.
Enrollment 74
Condition
Intervention

Intervention Type: Drug

Intervention Name: Clonazepam 0.5 MG

Description: Clonazepam 0.02 mg/kg only one dose

Arm Group Label: Single dose Clonazepam

Intervention Type: Drug

Intervention Name: Diazepam Tablets

Description: Diazepam 0.3 mg/kg every 8 hours for 3 doses. (24 hr)

Arm Group Label: Intermittent oral diazepam

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.

Gender: All

Minimum Age: 6 Months

Maximum Age: 60 Months

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Jinjutha Nithiuthai, MD Principal Investigator Queen Sirikit National Institute of Child Health
Overall Contact

Last Name: Jinjutha Nithiuthai, MD

Phone: +66806218033

Email: [email protected]

Verification Date

2020-04-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Queen Sirikit National Institute of Child Health

Investigator Full Name: Kullasate Sakpichaisakul

Investigator Title: Director of Pediatric Neurology

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Single dose Clonazepam

Type: Experimental

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)

Label: Intermittent oral diazepam

Type: Active Comparator

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.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

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

Masking: Triple (Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov

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