Acute seizure attack might cause mortality and morbidity among patients, so reliable methods to control the seizure- preferably applicable at home- should be developed. This study was performed as a randomized non-blind clinical trial on 60 patients coming to Imam Ali Hospital, Zahedan, Iran.
The patients were 2 months to 15 years old coming to our emergency department suffering from an acute seizure episode and fulfilled the including criteria. All of these patients were randomly divided into case and control groups, so there were 30 patients in each group.
Intranasal midazolam was administered 0.2 mg/kg equally dropped in both nostrils for case group and intravenous diazepam was administered 0.3mg/kg via IV line for control group.
After both treatments the time needed to control the seizure was registered by the practitioner. Pulse rate and O2 saturation was recorded at patient's entrance and in minutes 5 and 10 after drug administration.
General information
Acronym
None
IRCT registration information
IRCT registration number:IRCT201012105358N1
Registration date:2011-01-05, 1389/10/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-01-05, 1389/10/15
Registrant information
Name
Mohsen Javadzadeh
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2234 0128
Email address
m.javadzadeh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
The research administration of Zahedan University of Medical Sciences
Expected recruitment start date
2008-09-22, 1387/07/01
Expected recruitment end date
2009-05-22, 1388/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Efficacy and Side Effects of Intranasal Midazolam and Intravenous Diazepam in children with seizure attack
Public title
Comparing Midazolam and Diazepam in childhood seizures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria
Inclusion criteria were age between 2 months and 15 years, suffering from acute seizure episode and presence of parents (in order to acquire consent).
Exclusion criteria
Having an IV line before coming to our center, being administered with any kind of anticonvulsant drug, having any sign of upper respiratory tract infection.
Age
To 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zahedan Univrsity of Medical Sciences
Street address
Zahedan, Khalije Fars Highway, The University Campus
City
Zahedan
Postal code
Approval date
2007-11-22, 1386/09/01
Ethics committee reference number
1995-86
Health conditions studied
1
Description of health condition studied
epilepsy
ICD-10 code
G40
ICD-10 code description
Episodic and paroxysmal disorders
Primary outcomes
1
Description
Time needed to stop seizure
Timepoint
Once, After giving the medication
Method of measurement
Clinical observation
Secondary outcomes
1
Description
Heart rate
Timepoint
Twice, at 5, and 10 minutes after medication
Method of measurement
Counting the pulse rate
2
Description
Hb Oxygen saturation
Timepoint
Twice, At 5 & 10 minutes after medication
Method of measurement
Pulse Oxymetry
Intervention groups
1
Description
Intranasal midazolam was administered 0.2 mg/kg equally dropped in both nostrils for case group.
Category
Treatment - Drugs
2
Description
Intravenous diazepam was administered 0.3mg/kg via IV line for control group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan Imam-Ali Hospital
Full name of responsible person
Mohsen Javdazadeh, Child Neurolgist, Assistant Professor