Comparison of the seizure control with intravenous sodium valproate and Phenobarbital in children who referred to Ali-Ebn-Abitaleb hospital in Zahedan in 2012-2013.
Comparison of the seizure control with intravenous sodium valproate and Phenobarbital in children who referred to Ali-Ebn-Abitaleb hospital in Zahedan in 2012-2013.
Randomized clinical trial. Study sample:
Children with seizure who referred to Ali-Ebn-Abitaleb hospital in Zahedan in 2012-2013
we enrolled children who were experiencing convulsions while attending emergency rooms and whose seizures were not controlled by a bolus of intravenous diazepam (0.2 mg/kg) within 5 min. We excluded children with a history of adverse reactions to sodium sodium valproate or similar drugs, a history of uncontrolled bleeding, thrombocytopaenia, active hepatic disease, cardiac rhythm disturbances orthostatic hypotension, or syncope.Consecutive patients were enrolled and randomised in quaternary blocks to receive either intravenous sodium val¬proate rapid loading or intravenous phenobarbital.
after random allocation of patients to blocks, each patient received the medication package designed for that block. Phenobarbital was given at loading dose of 20 mg/kg via an infusion pump at a rate not faster than 60-100 mg/min. Sodium valproate was given at loading dose of 20 mg/kg, diluted in 20 ml saline.
The main outcome variable was termination of all convulsive activity, which should be achieved within 20 min of starting anticonvulsant infusion.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013071113956N1
Registration date:2013-09-11, 1392/06/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-09-11, 1392/06/20
Registrant information
Name
Saeedeh Yaghoobi
Name of organization / entity
Zahedan Univerdity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 1326 0407
Email address
zahedan.medical@gmail.com
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2013-06-22, 1392/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the seizure control with intravenous sodium valproate and Phenobarbital in children who referred to Ali-Ebn-Abitaleb hospital in Zahedan in 2012-2013.
Public title
Comparison of the drugs seizure control
Purpose
Treatment
Inclusion/Exclusion criteria
we enrolled children who were experiencing convulsions while attending emergency rooms and whose seizures were not controlled by a bolus of intravenous diazepam (0.2 mg/kg) within 5 min. We excluded children with a history of adverse reactions to sodium sodium valproate or similar drugs, a history of uncontrolled bleeding, thrombocytopaenia, active hepatic disease, cardiac rhythm disturbances orthostatic hypotension, or syncope.
Age
From 1 year old to 14 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
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 sciences
Street address
pardis zahedan university of medical sciencezahedan,dr hesabi circle,zahedan
City
zahedan
Postal code
Approval date
2012-08-13, 1391/05/23
Ethics committee reference number
91-913
Health conditions studied
1
Description of health condition studied
Seizure
ICD-10 code
G40-47
ICD-10 code description
Episodic and paroxysmal disorders
Primary outcomes
1
Description
Response to treatment
Timepoint
once after intervention then 20 minutes later
Method of measurement
View seizure control or lack of control
2
Description
recovery time
Timepoint
once after intervention then 20 minutes later
Method of measurement
measurement duration of seizure control with time unit(minite)
Secondary outcomes
empty
Intervention groups
1
Description
With the drug phenobarbital dose of 20 mg per kg body weight,single dose,in control group, within 20 minutes of seizure control is considered a positive response
Category
Treatment - Drugs
2
Description
With the drug sodium valproatel dose of 20 mg per kg body weight,single dose,in interventionl group, within 20 minutes of seizure control is considered a positive response
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan Aliebne Abitaleb hospital
Full name of responsible person
Saeedeh Yaghoobi, MD, pediatric resident
Street address
aliebne abitaleb hospital, khalije fars blvd,zahedan
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Assistant zahedan University of Medical Sciences
Full name of responsible person
Research Assistant zahedan University of Medical Sciences
Street address
Pardis zahedan university of medical science,dr hesabi circles,zahedan
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Assistant zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Saeedeh Yaghoobi
Position
MD, pediatric resident
Other areas of specialty/work
Street address
Zahedan University of Medical Sciences, Pardis, Dr Hesabi Squ., Zahedan
City
Zahedan
Postal code
98167-43463
Phone
+98 54 1341 4570
Fax
+98 54 1341 4561
Email
zahedan.medical@gmail.com
Web page address
www.zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Saeedeh Yaghoobi
Position
MD
Other areas of specialty/work
Street address
Zahedan University of Medical Sciences, Pardis, Dr Hesabi Squ., Zahedan
City
Aahedan
Postal code
98167-43463
Phone
+98 54 1341 4570
Fax
+98 54 1341 4561
Email
zahedan.medical@gmail.com
Web page address
www.zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Saeedeh Yaghoobi
Position
MD
Other areas of specialty/work
Street address
Zahedan University of Medical Sciences, Pardis, Dr Hesabi Squ., Zahedan
City
Zadedan
Postal code
98167-43463
Phone
+98 54 1341 4570
Fax
+98 54 1341 4561
Email
zahedan.medical@gmail.com
Web page address
www.zaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)