Single Dose of Clonazepam Versus Intermiittent Diazepam for Febrile Seizures Prevention
Paraules clau
Resum
Descripció
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.
Dates
Darrera verificació: | 03/31/2020 |
Primer enviat: | 04/04/2020 |
Inscripció estimada enviada: | 04/25/2020 |
Publicat per primera vegada: | 04/27/2020 |
Última actualització enviada: | 04/25/2020 |
Publicació de l'última actualització: | 04/27/2020 |
Data d'inici de l'estudi real: | 04/30/2020 |
Data estimada de finalització primària: | 04/29/2021 |
Data estimada de finalització de l’estudi: | 06/29/2021 |
Condició o malaltia
Intervenció / tractament
Drug: Single dose Clonazepam
Drug: Intermittent oral diazepam
Fase
Grups de braços
Braç | Intervenció / tractament |
---|---|
Experimental: Single dose Clonazepam Clonazepam(0.5 mg/tablet) 0.02 mg/kg orally once at the time of fever present. (body temperature more than 38 degree Celsius) | Drug: Single dose Clonazepam Clonazepam 0.02 mg/kg only one dose |
Active Comparator: Intermittent oral diazepam 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. | Drug: Intermittent oral diazepam Diazepam 0.3 mg/kg every 8 hours for 3 doses. (24 hr) |
Criteris d'elegibilitat
Edats elegibles per estudiar | 6 Months Per a 6 Months |
Sexes elegibles per estudiar | All |
Accepta voluntaris saludables | Sí |
Criteris | 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. |
Resultat
Mesures de resultats primaris
1. Recurrent rate of febrile seizures [the assessment will be done at 12 months after enrollment]
Mesures de resultats secundaris
1. Number of participants with adverse reaction of medications [7 days]
2. Associated factors: Sex [at the enrollment.]
3. Associated factors: age at first febrile seizure [at the enrollment]
4. Associated factors: the lowest temperature that cause seizure [at the enrollment.]
5. Number of participants with febrile convulsions in parents or siblings [at the enrollment.]
6. Number of participants with epilepsy in parents or siblings [at the enrollment.]
7. Number of participants with type of febrile seizures (simple or complex) [at the enrollment.]
8. Number of participants with delayed developmental milestones [at the enrollment.]