The purpose of this study is to compare clinical efficacy and safety of intravenous midazolam and sodium valproate infusion in treatment of status epilepticus in children.
In a randomized clinical trial study all of children with status epilepticus whom are admitted in Boo-Ali sina hospital and treated with drip of intravenous midazolam or sodium valproate. Seventy patients are evaluated in two groups of 35. Inclusion criteria: 1.Minimum age 3 month and maximum 14 years old; 2.Absence of renal or hepatic disfunction, shock, atrial or ventricular block; 3.No drug history of valproate or midazolam therapy in control of status epilepticus; 4.Normal range of CBC, BS,Ca, Na, K, BUN, Cr, SGOT, SGPT at beginning of treatment; 5.No control of status epilepticus with first line drugs such as diazepam, Phenytoin and Phenobarbital.
exclusion criteria: 1.all children with acute or chronic liver disease; 2.all children with metabolic disease; 3.seizure in children with trauma; 4.all children with coagulation disfunction
then response to treatment and complications are compared Pharmaceutical.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206101808N4
Registration date:2016-02-14, 1394/11/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-14, 1394/11/25
Registrant information
Name
Ali Abbaskhanian
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1223 3010
Email address
aabbaskhanian@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2014-08-23, 1393/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of continuous infusion of sodium valporate and midazolam in children status epilepticus
Public title
Comparison of sodium valporate and midazolam in children status epilepticus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Minimum age 3 month and maximum 14 years old ; Absence of renal or hepatic disfunction, shock, atrial or ventricular block ; No drug history of valproate or midazolam therapy in control of status epilepticus ; Normal range of CBC, BS,Ca, Na, K, BUN, Cr, SGOT, SGPT at beginning of treatment ; No control of status epilepticus with first line drugs such as diazepam, Phenytoin and Phenobarbital.
exclusion criteria: all children with acute or chronic liver disease ; all children with metabolic disease ; seizure in children with trauma ; all children with coagulation disfunction
Age
From 3 months old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Mazandaran University of Medical Sciences and Health Services
Street address
Imam Sq, Joybar 3way, Start of valiye asr highway
City
Sari
Postal code
Approval date
2016-01-26, 1394/11/06
Ethics committee reference number
IR.MAZUMS.REC.94-911
Health conditions studied
1
Description of health condition studied
status epilepticus
ICD-10 code
G41
ICD-10 code description
Status epilepticus
Primary outcomes
1
Description
status epilepticus treatment
Timepoint
before prevention and 24 hours after prevention
Method of measurement
questionarie
Secondary outcomes
1
Description
complications of treatment
Timepoint
during first 72 hours of prevention
Method of measurement
questionarie
Intervention groups
1
Description
Intervention: valproate Loading: 20mg/kg, then 20-30mg/kg/24 hr
Category
Treatment - Drugs
2
Description
Control: midazolam Loading: 0/15mg/kg, then 1-6µg/kg/min
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bouali sina hospital - pediateric Department
Full name of responsible person
Dr Ali Abbaskhanian
Street address
Emam sq - Pasdaran Blv
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Center of Mazandaran University of Medical Sciences and Health Services
Full name of responsible person
Dr Ahmad Ali Enayati
Street address
Moalem sq. Sari
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Center of Mazandaran University of Medical Sciences and Health Services
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
Mazandaran Univercity of Medical sciences and Health ervices
Full name of responsible person
Motahareh Kheradmand
Position
Master of science in nursing
Other areas of specialty/work
Street address
Moallem square
City
Sari
Postal code
Phone
00
Fax
Email
kheradmand@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaranl Univercity of medical sciences and Health services
Full name of responsible person
Dr Ali Abbaskhanian
Position
Pediatric neourologist
Other areas of specialty/work
Street address
Bouali sina hospital - Emam sq - Pasdaran Blv
City
Sari
Postal code
Phone
+98 11 3334 3010
Fax
Email
aabbaskhanian@mazus.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran Univercity of medical sciences and Health Services
Full name of responsible person
Dr Kobra Sheidaee
Position
Pediatrician
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)