Comparative study of the effect of diazepam suppositories and oral diazepam in the prophylaxis of febrile seizures in children referred to Amir Kabir Hospital of Neurology in 2016
Aim of this study Comparative study of the effect of Diazepam suppositories and oral Diazepam in the prophylaxis of febrile seizures in children referred to neurology clinic in Amir Kabir Hospital in 2016.This study is clinical trials and double blind. We will divide children 6 months to 60 months with febrile seizures referred to neurology clinic in Amir Kabir Hospital in two groups. We treat patients by 0.3 milligram in kilogram Oral Diazepam TDS in start of febrile to control febrile in first group. We treat patients by 0.5 milligram in kilogram Suppository Diazepam TDS in start of febrile to control febrile in second group.We will record number of frequent of febrile seizures in duration of treatment after one years.
Inclusion criteria: 6 months to 60 months with febrile seizures
Exclusion criteria: seizures with metabolic causes; seizures with central nervous system causes
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017070320258N50
Registration date:2017-07-06, 1396/04/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-06, 1396/04/15
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor and Research,Arak University of Medical Sciences
Expected recruitment start date
2016-02-19, 1394/11/30
Expected recruitment end date
2018-02-19, 1396/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of diazepam suppositories and oral diazepam in the prophylaxis of febrile seizures in children referred to Amir Kabir Hospital of Neurology in 2016
Public title
Comparative study of the effect of diazepam suppositories and oral diazepam in the prophylaxis of febrile seizures in children referred to Amir Kabir Hospital of Neurology in 2016
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 6 months to 60 months with febrile seizures
Exclusion criteria: seizures with metabolic causes; seizures with central nervous system causes
Age
From 6 months old to 5 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
212
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences
Street address
Dr Mohammad Rafiei, Vice chancellor for research, Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Postal code
38149578558
Approval date
2016-02-15, 1394/11/26
Ethics committee reference number
IR.ARAKMU.REC.1394.303
Health conditions studied
1
Description of health condition studied
febrile seizures
ICD-10 code
R56.0
ICD-10 code description
Febrile convulsions
Primary outcomes
1
Description
febrile seizures
Timepoint
before treatment and end of one years
Method of measurement
Number times of incidence
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: We treat patients by 0.3 milligram in kilogram Oral Diazepam TDS in start of febrile to control febrile in first group.
Category
Prevention
2
Description
Intervention group: We treat patients by 0.5 milligram in kilogram Suppository Diazepam TDS in start of febrile to control febrile in second group.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir hospital
Full name of responsible person
Dr Shariatmadari
Street address
Amirkabir hospital, Parastar square, Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences