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A randomized, multicenter, controlled trial of prophyractic use of diazepam for recurrence of febrile seizures during single febrile episode .

A randomized, multicenter, controlled trial of prophyractic use of diazepam for recurrence of febrile seizures during single febrile episode . - FS-1

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000004291
Enrollment
90
Registered
2010-09-29
Start date
2010-10-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Simple febrile seizure

Interventions

Single dose of diazepam 0.5mg/kg Two sequential doses of diazepam 0.5mg/kg with eight hours interval diazepam 0.3mg/kg/dose 3 times a day during febrile period (terminated after confirmation that feve

Sponsors

Tokyo Metropolitan Pediatric acute disease clinical research network
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. single 15 minutes or less generalized seizure episode within 72 hours 2. no prior use of anticonvulsant within 72 hours 3.body temperature >= 38.0 degree Celsius at visiting 4. six months to five years old. 5. alert conscious status with spontaneous eye opening and crying or spontaneous speech, and moves spontaneously or purposefully without the paralysis 6. no more than single history of afebrile seizures 7. absence of neurological disorder(include mental retardation and developmental disorder), malformation syndrome, dysmetabolic syndrome and electrolyte abnormality. 8. written consent from the parents

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

MeasureTime frame
proportion of patients occurring febrile seizures after registration.

Secondary

MeasureTime frame
adverse events frequency and duration prevalence of CNS infection, neurological disease and metabolic disease

Countries

Japan

Contacts

Public ContactYoshihiko Morikawa

Tokyo Metropolitan Children's Medical Center Department of Clinical Research

masaru_miura@tmhp.jp042-300-5111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026