Comparison of the therapeutic effect of parenteral Phenobarbital and oral Diazepam on recurrency of febrile seizure in hospitalized children- A randomized controlled clinical trial
Comparison of the therapeutic effect of parenteral Phenobarbital and oral Diazepam on recurrency of febrile seizure in hospitalized children
Design
Clinical trial with control group, with parallel groups,no blinding, randomized, phase 3 on 90 patients.Sealedenvelope software is used for randomization
Settings and conduct
This research will be performed on children aged 6 months to 6 years in 17 Shahrivar Hospital of Rasht for one year. After selecting the children ,written consent will be obtained from the parents . Will be registered. Randomization before the program will be done by considering 30 people in each group in 6 blocks and each of them in a separate envelope according to the list obtained from the software. The software is placed and closed in it and will be given to the third person. If the patient visits and is eligible, the envelope is opened and treated according to the desired sequence without knowing the next treatment. Group A will receive intravenous phenobarbital, group B will receive oral diazepam, and group C will be controlled, and the patient is unaware of the type of treatment
Participants/Inclusion and exclusion criteria
Inclusion criteria: Parents' satisfaction with the presence of children in the study, children aged 6 months to 6 years and experience the first febrile seizure
Non-entry criteria: Any neurological disease, history of previous seizures and febrile seizures, electrolyte imbalance associated with chronic disease
Intervention groups
1.Interavenous phenobarbital with dosage of 3 to 5 miligram per kilogram per day divided into 2 doses and prescribed for 3 days at the time of hospitalizatin
2.Oral diazepam at a dose of 33 miligram per kilogram 3times a day for 3 days in presence of fever is prescribed
3.The control group dose not receive drugs
Main outcome variables
Recurrence of febrile seizure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200608047689N2
Registration date:2021-02-04, 1399/11/16
Registration timing:registered_while_recruiting
Last update:2021-02-04, 1399/11/16
Update count:0
Registration date
2021-02-04, 1399/11/16
Registrant information
Name
Elham Bidabadi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3372 9104
Email address
bidabadi@mail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-27, 1399/11/08
Expected recruitment end date
2021-06-22, 1400/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the therapeutic effect of parenteral Phenobarbital and oral Diazepam on recurrency of febrile seizure in hospitalized children- A randomized controlled clinical trial
Public title
Comparison of the therapeutic effect of Diazepam and Phenobarbital in recurrence of febrile seizure
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Parents complete satisfaction with the children's presence in the study
Children who experience febrile seizure for the first time
Exclusion criteria:
History of any neurological disease
Children with previous history of seizure and febrile seizure
Imbalance of electrolytes associated with chronic disease
Age
From 6 months old to 6 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done before the start of the pragram by https://www.sealedenvelope.com considering 30 people in each group (3 groups of Diazepam, Phenobarbital, and control in 2 simple and complex strata) in 6 blocks. Any of them is placed in a separate envelope according to the list obtained from the software and it will be closed and provided to the third person. Patients names will be registered by admission. If the patient comes and is qualifed، the envelope will be opened and based on the expected sequence، he/she will be treated.
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
Ethics committee of the vice chancellor of Guilan University of Medical Sciences
Street address
Siadati street
City
Rasht
Province
Guilan
Postal code
4144444444
Approval date
2021-01-27, 1399/11/08
Ethics committee reference number
IR.GUMS.REC.1399.551
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 febrile seizure
Timepoint
The initial outcome will be measured during three days of hospitalization
Method of measurement
The occurrence of any types of seizure
Secondary outcomes
1
Description
The side effects of the drugs such as lethargy, rash and irritability
Timepoint
In 3 days during hospitalization
Method of measurement
The occurrence of complications
Intervention groups
1
Description
Intervention group: 1. Intravenous Phenobarbital at a dose of 3 to 5 milligrams per kilogram per day will be divided into two doses that will be administered daily for 3 days at the time of hospitalization.(Phenobarbital is a Barbiturate and from Chemidarou company with 200 milligrams/1 milliliter ampules.)
Category
Treatment - Drugs
2
Description
Intervention group: 2. Oral Diazepam at a dose of 33 milligrams per kilogram three times a day for three days during fever.(Diazepam is a Benzodiazepine and from Chemidarou company with 2 milligrams tablets.)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
17 Shahrivar Children's Hospital
Full name of responsible person
Elham Bidabadi
Street address
Siadati Street
City
Rasht
Province
Guilan
Postal code
4144654679
Phone
+98 13 3336 9061
Email
bidabadi@mail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammadreza Naghipour
Street address
Siadati Street
City
Rasht
Province
Guilan
Postal code
4144654679
Phone
+98 13 3336 9002
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Elham Bidabadi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
No. 15- 135 ave.- Golsar
City
Rasht
Province
Guilan
Postal code
4144654679
Phone
+98 13 3372 9104
Email
bidabadi@mail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Elham Bidabadi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
No. 15- 135 ave.- Golsar
City
Rasht
Province
Guilan
Postal code
4144654679
Phone
+98 13 3372 9104
Email
bidabadi@mail.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Elham Bidabadi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
No. 15- 135 ave.- Golsar
City
Rasht
Province
Guilan
Postal code
4144654679
Phone
+98 13 3372 9104
Email
bidabadi@mail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD