Comparison between Phenobarbital and Topiramate in prevention of relapse of febrile seizure in patients aged 6months to 5 years suffering from Febrile Convulsion
The purpose of this study is to compare the effects of phenobarbital and topiramate in the prevention of relapse of febrile convulsion. Patients who have febrile convulsion and haven’t received prophylaxis treatment and there is no evidence of metabolic or infectious cause for the convulsion are included in the study. The population under study is from 6 months to 5 years old suffering from febrile convulsion. Among these, 140 patients have been selected and have randomly been divided into two equal groups. The first group takes 5 mg per kg oral phenobarbital in two divided doses per day and the second group takes 5 mg per kg oral Topiramate per day for a year. To ensure proper use of the drug, the patient is asked to visit the clinic again after 1, 2, and 6 months from the first visit to be evaluated. After one year of treatment, patients in both groups are re-examined and after the assessment of the relapse of febrile convulsion, the data is recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013120710087N3
Registration date:2014-05-09, 1393/02/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-05-09, 1393/02/19
Registrant information
Name
Ali Khajeh
Name of organization / entity
Zahedan University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+54 13220316
Email address
khajeha@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellery of Research and Technology zahedan university of medical science
Expected recruitment start date
2011-12-11, 1390/09/20
Expected recruitment end date
2014-07-23, 1393/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between Phenobarbital and Topiramate in prevention of relapse of febrile seizure in patients aged 6months to 5 years suffering from Febrile Convulsion
Public title
Comparison between Phenobarbital and Topiramate in prevention of relapse of febrile seizure in patients aged 6months to 5 years suffering from Febrile Convulsion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients aged 6 months to 5 years suffering from febrile convulsion; if the first febrile convulsion occurs under 1 year of age; positive family history of febrile convulsion in first-degree relatives; low grade fever during the first attack (less than 39 °C); short period of time between the onset of fever and convulsion; multiple attacks of seizure; if the first febrile convulsion is complex.
Exclusion criteria: patients who have clinical or radiographic signs due to chronic mental disease (MR); patients who were diagnosed with meningitis considering the LP; patients whose seizure caused by electrolyte imbalance; history of a seizure without high temperature; patients who received prophylaxis treatment; patients who developed side effect due to receiving Topiramate.
Age
From 1 year old to 5 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
140
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
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zahedan University of Medical Science
Street address
Dr Hesabi square
City
Zahedan
Postal code
Approval date
2011-06-13, 1390/03/23
Ethics committee reference number
91-706
Health conditions studied
1
Description of health condition studied
Febrile Convulsions
ICD-10 code
R56.0
ICD-10 code description
Febrile convulsions
Primary outcomes
1
Description
Decreasing the relapse of Febrile Convulsion
Timepoint
After one year
Method of measurement
Clinical assessment
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group : The patients in the intervention group take 5 mg per kg oral Topiramate per day for a year. To ensure proper use of the drug, the patient is asked to visit the clinic again after 1, 2, and 6 months from the first visit to be evaluated. Patient who cant tolerate the drug due to side effects are excluded from the study. After one year of treatment, patients in both groups are re-examined and after the assessment of the relapse of febrile convulsion, the data is recorded.
Category
Treatment - Drugs
2
Description
Control group: The patients in the control group take 5 mg per kg oral phenobarbital in two divided doses per day for a year. To ensure proper use of the drug, the patient is asked to visit the clinic again after 1, 2, and 6 months from the first visit to be evaluated. Patient who cant tolerate the drug due to side effects are excluded from the study. After one year of treatment, patients in both groups are re-examined and after the assessment of the relapse of febrile convulsion, the data is recorded.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ebne Abitaleb Hospital
Full name of responsible person
Dr Ali Khaje (assistent professor, Specialty of pediatric neurology)
Street address
Khalij'e Fars highway- Ali Ebne Abitaleb Hospital
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciense
Full name of responsible person
Vice-Chancellery of Research and Technology of zahedan university of medical sciense
Street address
Dr Hesabi Square
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciense
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
Zahedan University of Medical Science
Full name of responsible person
Dr Ali Khaje
Position
Specialty of Pediatric Neurology
Other areas of specialty/work
Street address
Ali Ebne Abitaleb Hospital
City
Zahedan
Postal code
Phone
+98 54 1341 1260
Fax
Email
khajeha@zaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Science
Full name of responsible person
ِِDr Ali Khaje
Position
Specialty of Pediatric Neurology
Other areas of specialty/work
Street address
Ali Ebne Abitaleb Hospital
City
Zahedan
Postal code
Phone
+98 54 1341 1260
Fax
Email
khajeha@zaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Science
Full name of responsible person
Dr Ali Khaje
Position
Specialty of Pediatric Neurology
Other areas of specialty/work
Street address
Ali Ebne Abitaleb Hospital
City
Zahedan
Postal code
Phone
+98 54 1242 1638
Fax
Email
khajea@zaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)