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comparison diazepam and clobazam in prevention recurrence of febrile seizure

A comparative study of diazepam and clobazam in prevention recurrence of febrile seizure in children with age range of 6 month to 6 years of old admitted to Gorgan Taleghani hospital in 2011-2012

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013071514001N1
Enrollment
280
Registered
2013-08-09
Start date
2011-11-06
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

febrile seizure. Febrile convulsions

Interventions

Intervention 1: Treatment by diazepam Chemical composition: 7-chloro-1,3-dihydro-1-methyl-5-phenyl-1-benzodiazepin-, C16H13ClN2O , molecular weight: 284.7 Dosage: 0.33 mg/kg Frequency of drug use: 3
Treatment - Drugs
Treatment by diazepam Chemical composition: 7-chloro-1,3-dihydro-1-methyl-5-phenyl-1-benzodiazepin-, C16H13ClN2O , molecular weight: 284.7 Dosage: 0.33 mg/kg Frequency of drug use: 3 times per day
Treatment by clobazam Chemical composition: Chloro-1-methyl-5-phenyl-1,5-benzodiazepine, C16H13ClN2O2 , molecular weight: 300.74 Dosage: 2.5 mg for Children weighing less than 5 kg 5 mg for Chi

Sponsors

Research and Thecnology Deputy, Golestan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 72 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria includes patients with simple febrile seizure that their parents worry about recurrence of febrile seizure or live away medical centers and have no access to medical facilities and also children that have multiple caregiver. Exclusion criteria includes: 1) patients that have no generalized seizure or have focal signs and seizure takes more than 15 minutes and occurs more than one time in 24 hours, neurological abnormalities and abnormal neurologic examination and developmental disorders; 2) progressive neurological disease; 3) seizures during infection of the central nervous; 4) diagnosis is not febrile seizure and there are other causes and 5) abnormal EEG.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Recurrence of seizure. Timepoint: Every 3 months iduring intervention. Method of measurement: mg/kg.

Secondary

MeasureTime frame
Drug side effects. Timepoint: Every 3 monthes during intervention. Method of measurement: By asking parents.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahdi Jalili Akbarian

Golestan University of Medical Sciences

drmja2007@yahoo.com+98 17 1222 7721

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026