In this study we want to compare the efficacy and complications of buccal midazolam with intravenous diazepam in the treatment of acute seizures in Iranian children.
Materials and Methods: This is a prospective randomized controlled clinical trial in which 92 patients are randomly assigned to receive buccal midazolam or intravenous diazepam. The trial is conducted in the pediatric emergency unit or neurologic ward of Mofid children hospital , a referral center for neurologic emergency in Tehran. Patients aged 6 months to 14 years, presented with acute convulsion, were randomly assigned to receive buccal midazolam or intravenous diazepam. The primary outcome of this study is the time when seizure stopped after drug administration.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902293967N1
Registration date:2011-08-14, 1390/05/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-08-14, 1390/05/23
Registrant information
Name
Seyed Hassan Tonekaboni
Name of organization / entity
Mofid children hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 2290 9559
Email address
tonekaboni@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Pediatric Neurology Research Center
Expected recruitment start date
2007-12-24, 1386/10/03
Expected recruitment end date
2008-12-23, 1387/10/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing buccal midazolam vs. intravenous diazepam in control of acute seizures in children: a randomized clinical trial.
Public title
Comparing buccal midazolam vs. intravenous diazepam in control of acute seizures in children.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all children aged 6 months to 14 years old presenting with acute generalized seizure in emergency ward or pediatric neurology ward are randomly assigned to receive buccal midazolam or intravenous diazepam.
Exclusion criteria: seizures due to head trauma or known metabolic causes (hypoglycemia, hypocalcemia)
Age
To 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
N/A
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti Medical University
Street address
Ethics committee, Shahid Beheshti Medical University, next to Taleghani hospital, Evin, Chamran free way
City
Tehran
Postal code
Approval date
2007-12-23, 1386/10/02
Ethics committee reference number
001
Health conditions studied
1
Description of health condition studied
Acute childhood seizure
ICD-10 code
G40
ICD-10 code description
Epilepsy
Primary outcomes
1
Description
The time it takes to control seizure
Timepoint
The time it takes to control seizure is measured once after using IV diazepam vs. buccal midazolam
Method of measurement
Time measured in minute, evaluated from start to the end of seizure
Secondary outcomes
1
Description
Potential side effects
Timepoint
Potential side effects of the two drugs
Method of measurement
Clinical evaluation of possible side effect
Intervention groups
1
Description
Intervention group1: after establishing an intravenous route diazepam is infused 0.2-0.3 mg/kg to control seizure
Category
Treatment - Drugs
2
Description
Intervention group2: buccal midazolam is administered to children with convulsion based upon the age as follow: 2.5 mg for children aged 6-12 months 5mg for children 1-4 years 7.5 mg for children5-9 years 10 mg for children 10 years and older
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofid children hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pediatric Neurology Research Center
Full name of responsible person
Dr. Ghofrani
Street address
PNRC Ofiice, 2nd floor, Official building, Mofid Children Hospital, Shariati Avenue, befor Mirdamad St.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pediatric Neurology Research Center
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
Pediatric Neurology Research Center
Full name of responsible person
Dr. Seyed Hassan Tonekaboni
Position
Associate professor and pediatric neurologist
Other areas of specialty/work
Street address
Pediatric Neurology Research Center office, 2nd floor, mofid hospital, after Hosseynieh Ershad, Shariati avenue, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2290 9559
Fax
Email
tonekaboni@sbmu.ac.ir; shtonekaboni@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pediatric Neurology Research Center
Full name of responsible person
Seyed Hassan Tonekaboni
Position
Child Neurologist
Other areas of specialty/work
Street address
Pediatric Neurology Research Center office, 2nd floor, Mofid children hospital, after Hosseynieh Ershad, Shariati avenue, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2290 9559
Fax
Email
tonekaboni@sbmu.ac.ir; shtonekaboni@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Pediatric Neurology Research Center
Full name of responsible person
Saeede Aminzade
Position
Research Assistant
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
+98 21 2290 9559
Fax
Email
pnr.center@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)