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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose Clonazepam | Experimental | Clonazepam(0.5 mg/tablet) 0.02 mg/kg orally once at the time of fever present. (body temperature more than 38 degree Celsius) |
|
| Intermittent oral diazepam | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clonazepam 0.5 MG | Drug | Clonazepam 0.02 mg/kg only one dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent rate of febrile seizures | Rate of seizure occurs when the children have febrile illnesses (at the onset of fever until fever gone). The seizures will be reported by their parents/caregivers. (via the seizure record form and the interview.) Statistic analysis: Cumulative incidence (person-year). percent. Comparison between the two group by unpaired t test. | the assessment will be done at 12 months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse reaction of medications | The adverse reactions will be recorded by their caregivers in the record form for 7 days since patients taking the medication (clonapam or diazepam). The adverse reactions are drowsiness, ataxia, irritability, drooling, insomnia and rashes. Statistic analysis: cumulative incidence (person-year), Comparison between the two group by unpaired t test. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinjutha Nithiuthai, MD | Contact | 66806218033 | jinjutha.nt@gmail.com | |
| Sirorat Suwannachote, MD | Contact | 6623548333 | sirorat.s@rsu.ac.th |
| Name | Affiliation | Role |
|---|---|---|
| Jinjutha Nithiuthai, MD | Queen Sirikit National Institute of Child Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Sirikit National Institute of Child Health | Recruiting | Ratchathewi | Bangkok | 10400 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9111436 | Background | Berg AT, Shinnar S, Darefsky AS, Holford TR, Shapiro ED, Salomon ME, Crain EF, Hauser AW. Predictors of recurrent febrile seizures. A prospective cohort study. Arch Pediatr Adolesc Med. 1997 Apr;151(4):371-8. doi: 10.1001/archpedi.1997.02170410045006. | |
| 2137875 | Background | Berg AT, Shinnar S, Hauser WA, Leventhal JM. Predictors of recurrent febrile seizures: a metaanalytic review. J Pediatr. 1990 Mar;116(3):329-37. doi: 10.1016/s0022-3476(05)82816-1. |
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There is no plan to make IPD available due to the confidentiality.
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| ID | Term |
|---|---|
| D003294 | Seizures, Febrile |
| ID | Term |
|---|---|
| D012640 | Seizures |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D002998 | Clonazepam |
| D003975 | Diazepam |
| ID | Term |
|---|---|
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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A pragmatic parallel group randomized trial comparing single dose clonazepam with intermittent oral diazepam for prevention recurrent febrile seizures
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| Diazepam Tablets | Drug | Diazepam 0.3 mg/kg every 8 hours for 3 doses. (24 hr) |
|
| 7 days |
| Associated factors: Sex | To evaluate the associated factors of multiple recurrent febrile seizures. The data will be collected in the record form by the primary investigator at the enrollment. Statistic analysis: comparison between group by chi square | at the enrollment. |
| Associated factors: age at first febrile seizure | To evaluate the associated factors of multiple recurrent febrile seizures. The data will be collected in the record form by interviewing the caregivers to recall the information. Statistic analysis: comparison between group by unpaired t test | at the enrollment |
| Associated factors: the lowest temperature that cause seizure | To evaluate the associated factors of multiple recurrent febrile seizures. The data will be collected in the record form by interviewing the caregivers to recall the information. Statistic analysis: comparison between group by unpaired t test | at the enrollment. |
| Number of participants with febrile convulsions in parents or siblings | To evaluate the associated factors of multiple recurrent febrile seizures. The data will be collected in the record form by interviewing the caregivers. Statistic analysis: comparison between group by chi square | at the enrollment. |
| Number of participants with epilepsy in parents or siblings | To evaluate the associated factors of multiple recurrent febrile seizures. The data will be collected in the record form by interviewing the caregivers. Statistic analysis: comparison between group by chi square | at the enrollment. |
| Number of participants with type of febrile seizures (simple or complex) | To evaluate the associated factors of multiple recurrent febrile seizures. Type of febrile seizure
The data will be collected in the record form by interviewing the caregivers. Statistic analysis: comparison between group by chi square | at the enrollment. |
| Number of participants with delayed developmental milestones | The data will be collected by the developmental screening tools; Age and Stages Questionaires, third edition reported by the caregivers. Scoring will be done by neurology pediatrician at the enrollment. Age and Stages Questionaires(third editon) are divided in 5 areas; communication, gross motor, fine motor, problem solving, personal-social, each area has 6 questions. Scores for each area are between 0 to 60. The Cutoff points are different in each area. If the score is above the cutoff, the children development appears normal for age. (The cutoff for communication is 29.65, Gross motor is 22.25, fine motor is 25.14, problem solving is 27.72 and personal-social is 25.34) Statistic analysis: comparison between group by unpaired t test | at the enrollment. |
| 9851235 | Background | Kolfen W, Pehle K, Konig S. Is the long-term outcome of children following febrile convulsions favorable? Dev Med Child Neurol. 1998 Oct;40(10):667-71. doi: 10.1111/j.1469-8749.1998.tb12326.x. |
| 22937894 | Background | Visser AM, Jaddoe VW, Ghassabian A, Schenk JJ, Verhulst FC, Hofman A, Tiemeier H, Moll HA, Arts WF. Febrile seizures and behavioural and cognitive outcomes in preschool children: the Generation R study. Dev Med Child Neurol. 2012 Nov;54(11):1006-11. doi: 10.1111/j.1469-8749.2012.04405.x. Epub 2012 Sep 3. |
| 27412639 | Background | Bertelsen EN, Larsen JT, Petersen L, Christensen J, Dalsgaard S. Childhood Epilepsy, Febrile Seizures, and Subsequent Risk of ADHD. Pediatrics. 2016 Aug;138(2):e20154654. doi: 10.1542/peds.2015-4654. Epub 2016 Jul 13. |
| 31618476 | Background | Billstedt E, Nilsson G, Leffler L, Carlsson L, Olsson I, Fernell E, Gillberg C. Cognitive functioning in a representative cohort of preschool children with febrile seizures. Acta Paediatr. 2020 May;109(5):989-994. doi: 10.1111/apa.15059. Epub 2019 Nov 10. |
| 8510706 | Result | Rosman NP, Colton T, Labazzo J, Gilbert PL, Gardella NB, Kaye EM, Van Bennekom C, Winter MR. A controlled trial of diazepam administered during febrile illnesses to prevent recurrence of febrile seizures. N Engl J Med. 1993 Jul 8;329(2):79-84. doi: 10.1056/NEJM199307083290202. |
| 3907504 | Result | Knudsen FU. Recurrence risk after first febrile seizure and effect of short term diazepam prophylaxis. Arch Dis Child. 1985 Nov;60(11):1045-9. doi: 10.1136/adc.60.11.1045. |
| 19125841 | Result | Capovilla G, Mastrangelo M, Romeo A, Vigevano F. Recommendations for the management of "febrile seizures": Ad Hoc Task Force of LICE Guidelines Commission. Epilepsia. 2009 Jan;50 Suppl 1:2-6. doi: 10.1111/j.1528-1167.2008.01963.x. |
| 28225210 | Result | Offringa M, Newton R, Cozijnsen MA, Nevitt SJ. Prophylactic drug management for febrile seizures in children. Cochrane Database Syst Rev. 2017 Feb 22;2(2):CD003031. doi: 10.1002/14651858.CD003031.pub3. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |