Serial seizures may have side effects on brain. In our hospital, the first approach as the routine approach for refractory serial seizure is admission of the patient in the Pediatric Intensive Care Unit (PICU) and starting intravenous midazolam infusion. Limited PICU services in some remote hospitals were the main drawback of this approach serial seizures may have side effects on brain. In our hospital, the first approach as the routine approach for refractory serial seizure is admission of the patient in the Pediatric Intensive Care Unit (PICU) and starting intravenous midazolam infusion. Limited PICU services in some remote hospitals were the main drawback of this approach. The aim of this study was achievement of a new method for treatment of patients with serial seizures when transfer to the PICU is not possible. this study included all admitted children with refractory serial seizures in Mofid hospital, which is a referral center for pediatric neurological diseases, The diagnostic criteria for refractory serial seizures in this study was defined as four generalized tonic-clonic or complex partial seizures per day with a three-fold increase over usual seizure frequency within a two-day period that received at least two appropriate intravenous, intramuscular or oral antiepileptic drugs with no decrease to less than the pretreatment level in seizure frequency. Patients were randomly assigned to midazolam or diazepam groups. We survey patients in both groups for duration of admission, stay in ICU, side effects and need to mechanical ventilation. The aim of this study was achievement of a new method for treatment of patients with serial seizures when transfer to the PICU is not possible.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012082210634N1
Registration date:2012-09-20, 1391/06/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-09-20, 1391/06/30
Registrant information
Name
Afshin Fayazi
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1264 0075
Email address
afshin_fay@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor of Research and Technology of Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2010-08-23, 1389/06/01
Expected recruitment end date
2011-03-20, 1389/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intravenous midazolam drip with intermittent intravenous diazepam in the treatment of refractory serial seizures in children
Public title
Intermittent intravenous diazepam in the treatment of refractory serial seizures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children > 1 mo old; Children with serial seizures; Children with refractory epilepsy and no response to conventional drugs during first 6 hours
Exclusion criteria
Drug side effects; Exacerbation of seizure during treatments; Status ٍEpilepticus
Age
From 1 year old to 15 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Velenjak Street, Shahid Chamran High Way , Shahid Beheshti University of Medical Sciences
City
Tehran
Postal code
Approval date
2010-10-10, 1389/07/18
Ethics committee reference number
88-01-146-6383-3571
Health conditions studied
1
Description of health condition studied
Serial Seizures
ICD-10 code
G40.9
ICD-10 code description
Epilepsy, unspecified
Primary outcomes
1
Description
Duration of seizure control
Timepoint
Hour
Method of measurement
Observation
Secondary outcomes
1
Description
Duration of stay in hospital and PICU
Timepoint
Day
Method of measurement
Observation
Intervention groups
1
Description
In cases group:
Intravenous diazepam was administered every 3 hours (0.2 mg /kg).
Category
Treatment - Drugs
2
Description
In control group:
Midazolam was administered as an intravenous bolus dose (0.2mg/kg), followed by continuous intravenous infusion (1-10 μg/kg per min).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofid Hospital
Full name of responsible person
Dr.Parvaneh Karimzadeh
Street address
Shariati Av
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of Research and Technology of shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Mohammad Rahmati
Street address
Velenjak Street, Shahid Chamran High Way, Shahid Beheshti University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of Research and Technology of shahid Beheshti 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
Hamedan University of Medical Sciences
Full name of responsible person
dr. Afshin Fayazi
Position
Assistant Professor
Other areas of specialty/work
Street address
Besat Hospital
City
Hamedan
Postal code
Phone
+98 81 1264 0075
Fax
Email
afshin_fay@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences,
Full name of responsible person
Afshin Fayazi
Position
Assistant Professor
Other areas of specialty/work
Street address
Besat hospital
City
Hamedan
Postal code
Phone
+98 81 1264 0075
Fax
Email
afshin_fay@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Afshin Fayazi
Position
Assistant Professor
Other areas of specialty/work
Street address
Besat Hospital
City
Hamadan
Postal code
Phone
+98 81 1264 0075
Fax
Email
afshin_fay@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)