The Comparative Study of Diazepam with Two Different Doses in Prevention of Febrile Seizure Recurrence and its Complications in Children Aged 6 Months to 6 Years Old
The purpose of this study is to compare the efficacy and side effects of the low-dose diazepam and recommended dose of diazepam for prevention of recurrence of febrile seizures in children 6 months to 6 years old. Inclusion criteria for the study Will considered the children 6 months to 6 years (male and female) with generalized tonic-colonic seizure that takes less than 15 minutes and can occur only once in 24 hours . And exclusion criteria will be included who do not have mentioned conditions And do not have neurological disorders and also neurologic progressive underlying disease or seizure cause by meningitis or electrolyte imbalance, or who had abnormal EEG. The study population will selected of patients referred to Taleghani hospital with first simple febrile seizure and selected parallel in the two groups. The sample size were included 140 patients in each group. .there is no blindness in this study so patients and physicians will be aware of the type of treatment. Finally, our intervention will be compare the effect of different doses of the diazepam in the prevention of febrile seizures . Samples will be collected in years 2012 and 2013 and will be followed for each sample to 1 year. Finally, by comparing different doses of diazepam in preventing febrile seizure can be prevented occurrence of adverse consequences of the disease by determining the best therapeutic dose And this way help to better control the patient disease
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014102719700N1
Registration date:2015-02-14, 1393/11/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-02-14, 1393/11/25
Registrant information
Name
shima shekari
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 173243031020
Email address
shekari61@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Govermetal
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2013-09-23, 1392/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparative Study of Diazepam with Two Different Doses in Prevention of Febrile Seizure Recurrence and its Complications in Children Aged 6 Months to 6 Years Old
Public title
The Comparative Study of Diazepam with Two Different Doses in Prevention of Febrile Seizure Recurrence and its Complications in Children Aged 6 Months to 6 Years Old
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patient who do not have generalized seizure and a focal sign and Seizure prolong more than 15 minute and seizure more than 1 time in a day; Abnormal neurological function abnormal neurological examination and development disorder; Progressive neurological disease; Seizure due to central nerves system infection.
Exclusion criteria: Seizure for other reasons is not FC (epilepsy (epilepsy, electrolyte disorders, trauma, etc.); The presence of abnormal EEG.
Age
From 6 months old to 5 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
280
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
The Comparative Study of Diazepam with Two Different Doses in Prevention of Febrile Seizure Recurrence and its Complications in Children Aged 6 Months to 6 Years Old Referred to Taleghani Hospital of Gorgan in 2012-2013
Secondary trial Id
1723059307208
Registration date
2014-10-19, 1393/07/27
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Golestan University of Medical Sciences
Street address
Central Organization of Golestan University of Medical Sciences, Boulevard Hyrkan, Gorgan, Golestan.
City
Gorgan
Postal code
4918936316
Approval date
2014-10-19, 1393/07/27
Ethics committee reference number
017230593072080
Health conditions studied
1
Description of health condition studied
Febrile Seizure
ICD-10 code
R50.R69
ICD-10 code description
Febrile convulsions
Primary outcomes
1
Description
Febrile Seizure
Timepoint
one year
Method of measurement
questionnaire
Secondary outcomes
1
Description
Side effects
Timepoint
one year
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: Diazepam, dose: 0.3 mg for each kg of body weight, frequency of use: 3, duration: 8 hours
Category
Prevention
2
Description
Intervention group: Diazepam, dose: 0.3 mg for each kg of body weight, frequency of use: 2, duration: 12 hours
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital Taleghani
Full name of responsible person
Shima Shekari
Street address
Central Organization of Golestan University of Medical Sciences, Boulevard Hyrkan, Gorgan, Golestan.
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research Golestan University of Medical Sciences
Full name of responsible person
Siamak Rajaei
Street address
Central Organization of Golestan University of Medical Sciences, Boulevard Hyrkan, Gorgan, Golestan.
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research Golestan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Shima Shekari
Position
Resident of Pediatric / students
Other areas of specialty/work
Street address
Central Organization of Golestan University of Medical Sciences, Boulevard Hyrkan, Gorgan, Golestan
City
Gorgan
Postal code
Phone
+98 173243310
Fax
Email
shekari61@guoms.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Speide Amouian
Position
Professor of Neurology
Other areas of specialty/work
Street address
Central Organization of Golestan University of Medical Sciences, Boulevard Hyrkan, Gorgan, Golestan
City
Gorgan
Postal code
Phone
+98 17 3243 0310
Fax
Email
amouian@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Shima Shekari
Position
Resident of Pediatric / students
Other areas of specialty/work
Street address
Central Organization of Golestan University of Medical Sciences, Boulevard Hyrkan, Gorgan, Golestan
City
Gorgan
Postal code
Phone
+98 17 3243 0310
Fax
Email
shekari61@guoms.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)