Comparison of diazepam and clobazam in preventing the recurrence of febrile seizures in children aged 6 months to 5 years of age admitted to Kashan Shahid Beheshti Hospital
(1) Objectives: To compare the effect of diazepam and clobazam in preventing the recurrence of febrile seizures in children. (2) Design: Clinical trial. (3) Setting and conduct: Double blinded. (4) Participants: The main inclusion criteria is the age range from 6 months to 5 years and the first episode of febrile seizure (rectal temperature grater than 38 degrees centigrade). Patients with CSF infections, acute electrolyte disturbances, previous history of seizures without fever or an underlying neurological condition were excluded from the study. Also in case of parents' dissatisfaction or their lack of cooperation patients would be omitted from the study. (5) Intervention: Preventive treatment were given with 0.33 mg/kg of diazepam orally three times a day and 1 mg/kg of clobazam orally two times a day for 48 hours at the time of fever. (6) Main outcome measures: The relapse within one year after the first occurrence.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014070318344N1
Registration date:2014-09-23, 1393/07/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-09-23, 1393/07/01
Registrant information
Name
Shirin Vafaee
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
shirinvafaee@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Kashan University of Medical Sciences
Expected recruitment start date
2013-02-03, 1391/11/15
Expected recruitment end date
2014-02-04, 1392/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of diazepam and clobazam in preventing the recurrence of febrile seizures in children aged 6 months to 5 years of age admitted to Kashan Shahid Beheshti Hospital
Public title
Comparison of clobazam and diazepam in preventing the recurrence of febrile seizures
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: children aged 6 months to 5 years with the first attack of febrile convulsion(rectal temperature greater than 38° C)/ Exclusion criteria: Patients who have CNS infection and/or acute electrolyte imbalance and a history of previous seizure in the absence of fever; lack of cooperation or loss to follow up( for example changing the place of living); parents' discontent to participate in the study; having an underlying neurological disorder.
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:
160
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
Kashan University of Medical Sciences ethics committee
Street address
Vice chancellor for research, Kashan Medical Sciences complex, Ghotbe Ravandi Blvd.
City
Kashan
Postal code
Approval date
2013-01-23, 1391/11/04
Ethics committee reference number
29/5/1/4867/پ
Health conditions studied
1
Description of health condition studied
Febrile sizure
ICD-10 code
R56.0
ICD-10 code description
Febrile convulsions
Primary outcomes
1
Description
Recurrence of febrile seizures
Timepoint
Every three months during the intervention in a period twelve months
Method of measurement
asking the parents and visit by the pediatric neurologist
Secondary outcomes
1
Description
Drugs side effects
Timepoint
Every three months during the intervention in a period twelve months
Method of measurement
asking the parents and visit by the pediatric neurologist
Intervention groups
1
Description
Oral diazepam at a dose of 0.33 mg per kilogram of body weight per dose three times a day for 48 hours after the onset of fever
Category
Treatment - Drugs
2
Description
Oral clobazam at a dose of 1 mg per kilogram of body weight per dose twice a day for 48 hours after the onset of fever
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan Shahid Beheshti Hospital
Full name of responsible person
Dr.Shirin Vafaei
Street address
Shahid Behesti Hospital, Ghotbe Ravandi Blvd.
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholam Ali Hamidi
Street address
Vice Chancellor for research, Pezeshk Blvd., Ghotbe Ravandi Blvd.
City
Kashan
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, Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Dr. Shirin Vafaei
Position
Pediatrics resident
Other areas of specialty/work
Street address
Pediatrics group, second floor, Shahid Beheshti Hospital, Ghotbe Ravandi Blvd.
City
Kashan
Postal code
Phone
+98 31 5554 0021
Fax
Email
shirinvafaee@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Shirin Vafaei
Position
Pediatrics resident
Other areas of specialty/work
Street address
Pediatrics group, second floor, Shahid Beheshti Hospital, Ghotbe Ravandi Blvd.
City
Kashan
Postal code
Phone
+98 31 5554 0021
Fax
Email
shirinvafaee@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Shirin Vafaei
Position
Pediatrics resident
Other areas of specialty/work
Street address
Pediatrics group, second floor, Shahid Beheshti Hospital, Ghotbe Ravandi Blvd.
City
Kashan
Postal code
Phone
+98 31 5554 0021
Fax
Email
shirinvafaee@kaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)