In a randomized clinical trial , sixty children aged 1-7 years ,whom referred to MRI of Shahid Sadoughi Hospital and who don’t naturally sleep and immobilize, will be randomly assigned to receive combination of 40 mg/kg of chloral hydrate and 1mg/kg hydroxyzine or 40 mg/kg of chloral hydrate and 0.5mg/kg oral midazolam.
Efficacy of drugs in adequate sedation induction( Ramsay score of four) , time to induction of adequate sedation, total stay time in MRI unit , side effects and caregiver’s satisfaction are also compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201302092639N10
Registration date:2013-02-23, 1391/12/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-02-23, 1391/12/05
Registrant information
Name
Razieh Fallah
Name of organization / entity
Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Country
Iran (Islamic Republic of)
Phone
+98 35 3822 4000
Email address
fallah@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
deputy of Research of Shahid Sadoughi University of Medical Sciences ,Yazd,Iran
Expected recruitment start date
2012-11-30, 1391/09/10
Expected recruitment end date
2013-03-30, 1392/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy of chloral hydrate -hydroxyzine and chloral hydrate – oral midazolam in sedation induction for MRI in children
Public title
chloral hydrate -hydroxyzine and chloral hydrate – oral midazolam in sedation induction for MRI in children
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: 1. Children who are referred to MRI Unit but don’t obey, 2. Age 1-7 years old 3. Class 1 or 2 of ASA 4. Do not receive a sedative hypnotic agent within the past 48 hours
Exclusion criteria: 1. Presence of gastritis or any other serious systemic diseases 2. Severe systemic reaction 3. History of allergy to drug 4. The patient does not use the drug completely
Age
From 1 year old to 7 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)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadoughi University of Medical Sciences ,Yazd,Iran
Street address
Bahonar Square, Central Building of University
City
Yazd
Postal code
Approval date
2012-11-21, 1391/09/01
Ethics committee reference number
119121/1/17
Health conditions studied
1
Description of health condition studied
CNS diseases
ICD-10 code
G90-G99
ICD-10 code description
Other disorders of the nervous system
Primary outcomes
1
Description
adequate sedation (Ramsay score of four is attained)
Timepoint
every 15 minutes
Method of measurement
clinical exam
2
Description
success in taking of MRI
Timepoint
every 15 minutes
Method of measurement
clinical exam
Secondary outcomes
1
Description
time to induction of adequate sedation
Timepoint
every 15 minutes
Method of measurement
clinical examination
2
Description
side effects
Timepoint
every 15 minutes
Method of measurement
clinical examination
3
Description
total stay time in MRI unit
Timepoint
Every 30 minutes
Method of measurement
asking from parents
4
Description
caregiver’s satisfaction
Timepoint
after two hours of drug use
Method of measurement
asking from caregiver
Intervention groups
1
Description
combination of 40 mg/kg of chloral hydrate and 1mg/kg hydroxyzine
Category
Other
2
Description
40 mg/kg of chloral hydrate and 0.5mg/kg oral midazolam
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
MRI Unit of Shahid Sadoughi Hospital
Full name of responsible person
Street address
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research of Shahid Sadoughi University of Medical Sciences,Yazd,Iran
Full name of responsible person
Dr.Fatemeh Ezoddini
Street address
Bahonar Square , Central buliding of University
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research of Shahid Sadoughi University of Medical Sciences,Yazd,Iran
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
Shahid Sadoughi University of Medical Sciences , Yazd , Iran
Full name of responsible person
Dr.Razieh Fallah
Position
Associate professor, Pediatric Neurologist
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital, Ave sina St, Shahid Ghandi Blvd,
City
Yazd
Postal code
Phone
+98 35 1822 4000
Fax
Email
FALLAH@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences, Yazd,Iran
Full name of responsible person
Dr.Razieh Fallah
Position
Associate professor, Pediatric Neurologist
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital
City
Yazd
Postal code
Phone
+98 35 1822 4000
Fax
Email
FALLAH@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)