The purpose of this study is evaluation of the effects of various sedative drugs in children during diagnostic procedures. This study is a randomized, double-blind, without placebo control that will be done in children 2 to 10 years candidate for CT scan or audiometery that have not any history of taking sedatives, opioids, anticonvulsants drug. 60 patients will be randomized to three groups and will receive midazolam, ketamine and chlorate hydrate. The separation of children from their parents, sedation and anxiety will be controlled every 5 minutes and patient movement measured in several minute and will be compared between the groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015010612642N9
Registration date:2015-01-18, 1393/10/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-01-18, 1393/10/28
Registrant information
Name
Majid Golestani Eraghi
Name of organization / entity
Shahid Beheshti University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 3336 0547
Email address
dr.golestani@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the sedative effect of oral ketamine, midazolam and chloral hydrate in children candidate for noninvasive diagnostic procedures
Public title
Sedative effect of ketamine, midazolam and oral chloral hydrate in children
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: Candidate for CT scan; candidate for audiometry; age between 2 to 10 years old; ASA I,II
exclusion criteria: History of taking sedative drugs, history of drug abuse, history of taking anticonvulsants, history of allergy
Age
From 2 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chancellor for Research and Technology Ethics Committee ُShahid Beheshti University of Medical
Street address
Daneshjoo Ave-Velenjak
City
Tehran
Postal code
Approval date
2013-09-14, 1392/06/23
Ethics committee reference number
400/4012
Health conditions studied
1
Description of health condition studied
Oral sedation in children
ICD-10 code
F44.6
ICD-10 code description
Dissociative anaesthesia and sensory loss
Primary outcomes
1
Description
time of separating from parents
Timepoint
Every 5 min after administration
Method of measurement
Based on the examination by the research team
2
Description
sedation
Timepoint
Every 5 min after administration
Method of measurement
Based on the examination by the research team based on sedatin score
3
Description
anxiety
Timepoint
Every 5 min after administration
Method of measurement
Based on the examination by the team on the anxiety sedation table
4
Description
The children move during the procedure
Timepoint
0,15 and 30 minute after drug administration
Method of measurement
Based on the examination by the team on the anxiety sedation table
Secondary outcomes
1
Description
Children waking time
Timepoint
Since taking oral medication
Method of measurement
Based on the examination by the team in minutes
2
Description
nausea
Timepoint
After taking oral medication
Method of measurement
Questions from Parents
Intervention groups
1
Description
Midazolam group, patients administered 0 / 5mg / kg orally midazolam, and every 5 minutes to allow the separation of children from their parents will controle
Category
Treatment - Drugs
2
Description
ketamin group, patients administered 5mg / kg oraly ketamin, and every 5 minutes to allow the separation of children from their parents will controle
Category
Treatment - Drugs
3
Description
chlorate Hydrate group, patients administered 50mg / kg orally chlorate Hydrate, and every 5 minutes to allow the separation of children from their parents will controle
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hospital, Makhsoos Ave, Lashkar Crossroad
Full name of responsible person
Majid Golestani Eraghi
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Daneshjoo Ave- Velenjak
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 for Research and Technology 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Did you mean: گروه بیهوشی دانشگاه علوم پزشکی شهید بهشتی Department of Anesthesiology, Shahid Behesht
Full name of responsible person
Farhad Safari
Position
Anesthesiologist
Other areas of specialty/work
Street address
Darabad
City
Tehran
Postal code
Phone
+98 21 2712 2525
Fax
Email
fsafari@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Anesthesiology, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Majid Golestani Eraghi
Position
Fellowship specialty intensive care
Other areas of specialty/work
Street address
Masih Daneshvari Hospital, Darabad Ave
City
Tehran
Postal code
Phone
+98 21 2712 2525
Fax
Email
dr.golestani@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)