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
In this investigation, tow drugs, diazepam and clobazam, will be studied for evaluating prevention of febrile seizure recurrence in patients admitted in Gorgan Taleghani Hospital. Study is randomized, not referred and single central. 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. 140 patients will be studied in each group. Diazepam takes as 0.33 mg/kg/dose Q 8h and clobazam takes bases on weight body in 2.5, 5, 7.5 and 10 mg/kg dosage. The research will be started in 2011 and results involving episodes of fever every 3 months, drug side effects and seizure recurrence will be registered in a check list.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013071514001N1
Registration date:2013-08-09, 1392/05/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-09, 1392/05/18
Registrant information
Name
Mahdi Jlili Akbarian
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 1554 7525
Email address
ethic-committee@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
The cost of the plan funds of the Research and Technology Deputy of Golestan University of Medical Sciences
Expected recruitment start date
2011-11-06, 1390/08/15
Expected recruitment end date
2012-11-05, 1391/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
comparison diazepam and clobazam in prevention recurrence of febrile seizure
Purpose
Treatment
Inclusion/Exclusion 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.
Age
From 6 years old to 72 years old
Gender
Both
Phase
2-3
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
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research and Thecnology Deputy, Golestan University of Medical Sciences
Street address
Falsafi Higher Education Bilding, beginning of Shastkola roade,
City
Gorgan
Postal code
Approval date
2011-11-06, 1390/08/15
Ethics committee reference number
191390081504
Health conditions studied
1
Description of health condition studied
febrile seizure
ICD-10 code
R56.0
ICD-10 code description
Febrile convulsions
Primary outcomes
1
Description
Recurrence of seizure
Timepoint
Every 3 months iduring intervention
Method of measurement
mg/kg
Secondary outcomes
1
Description
Drug side effects
Timepoint
Every 3 monthes during intervention
Method of measurement
By asking parents
Intervention groups
1
Description
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
Duration of drug use: 48 hours
Category
Treatment - Drugs
2
Description
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 Children weighing 6-10 kg
7.5 mg for Children weighing 11- 15 kg
10 mg for Children weighing more than 15 kg
Frequency of drug use: 2 times per day, every 12 hours
Duration of drug use: 48 hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Seoideh Amouian
Street address
Janbazan Boulevard, Taleghani Hospital
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research and Thecnology Deputy, Golestan University of Medical Sciences
Full name of responsible person
Mohammad Jafar Golalipour
Street address
Falsafi Higher Education Bilding, beginning of Shastkola roade,
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research and Thecnology Deputy, 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
Mahdi Jalili Akbarian
Position
MD
Other areas of specialty/work
Street address
Taleghani Hospital, Janbazan Boulevard
City
Gorgan
Postal code
Phone
+98 17 1222 7721
Fax
Email
drmja2007@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Sepodeh Amouian
Position
Assistant professor
Other areas of specialty/work
Street address
Taleghani Hospital, Janbazan Boulevard
City
Gorgan
Postal code
Phone
+98 17 1222 7721
Fax
Email
amoian_sep@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Golestan University of Medical Sciances
Full name of responsible person
Mahdi Jalili Akbarian
Position
MD
Other areas of specialty/work
Street address
Taleghani Hospital, Janbazan Boulevard
City
Gorgan
Postal code
Phone
+98 17 1222 7721
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)