Comparison of the efficacy of oral midazolam and intranasal midazolam in sedation for diagnostic procedures (radiology and sonography, CT scan) in children referred to the ED
Comparison of the efficacy of oral midazolam and midazolam in the nasal passages for relaxation in diagnostic radiology (CT scan, radiology and ultrasound) of children referred to the emergency department of Bahonar
Design
The first participant in the study is randomly assigned to one of the groups based on randomization table (Appendix 2 below), and the next patient will be assigned so. 15 min before the procedure, children in intranasal midazolam group (0.2 mg / kg) and 30 minutes before the procedure, patients in oral midasolam group ( 0.5 mg / kg) receive the drug , then If the target sedation was done , the child will be transferred to a diagnostic radiologic procedure (CT scan, radiology, and ultrasound). After completing the diagnostic action, the data sheet is completed and the patient's vital signs are again checked. If the child was in good condition he or she undergo other diagnostic or therapeutic process. if unstable, the child will be resuscitated. finally the care sheet will be delivered to parents.
Settings and conduct
clinical trial at Bahonar hospital ED
Participants/Inclusion and exclusion criteria
A study was conducted on 74 children aged 2 to 12 years old for diagnostic radiology (CT scan, radiology, and ultrasonography) to the emergency department at Bahonar Hospital in 1964-09.
Intervention groups
The first participant in the study is randomly assigned to one of the groups(intranasal and oral groups) based on randomization table (Appendix 2 below), and the next patient will be assigned so.And no one Knows anything about allocation.
Main outcome variables
sedation
General information
Reason for update
Acronym
The comparison of effectiveness of oral midazolam and intranasal midazolam on sedation of children
IRCT registration information
IRCT registration number:IRCT20171009036661N3
Registration date:2018-12-03, 1397/09/12
Registration timing:retrospective
Last update:2018-12-03, 1397/09/12
Update count:0
Registration date
2018-12-03, 1397/09/12
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3335 6220
Email address
m.mayel@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
2015-05-22, 1394/03/01
Actual recruitment end date
2018-02-09, 1396/11/20
Trial completion date
2018-03-16, 1396/12/25
Scientific title
Comparison of the efficacy of oral midazolam and intranasal midazolam in sedation for diagnostic procedures (radiology and sonography, CT scan) in children referred to the ED
Public title
The effect of intranasal midazolam on children sedation
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
age 2 to 12 years old
mild to moderate traumatic brain injury
no concomitant nasal trauma or nasal anatomic abnormality
The first participant in the study is randomly assigned to one of the groups based on randomization table (Appendix 2 below), and the next patient will be assigned so. 15 min before the procedure, children in intranasal midazolam group (0.2 mg / kg) and 30 minutes before the procedure, patients in oral midasolam group ( 0.5 mg / kg) receive the drug , then If the target sedation was done , the child will be transferred to a diagnostic radiologic procedure (CT scan, radiology, and ultrasound). After completing the diagnostic action, the data sheet is completed and the patient's vital signs are again checked. If the child was in good condition he or she undergo other diagnostic or therapeutic process. if unstable, the child will be resuscitated. finally the care sheet will be delivered to parents.
Blinding (investigator's opinion)
Single blinded
Blinding description
The first participant in the study is randomly assigned to one of the groups based on randomization table (Appendix 2 below), and the next patient will be assigned so.And no one Knows anything about allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kerman University of Medical Sciences
Street address
Somayeh Cross road - Research Center - Kerman University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7613747181
Approval date
2017-07-23, 1396/05/01
Ethics committee reference number
ir.kmu.rec.1395.361
Health conditions studied
1
Description of health condition studied
Pediatrics Sedation
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sedation Level
Timepoint
15 minutes after intranasal method and 30 minutes after oral method
Method of measurement
Nialc Wilton Method
Secondary outcomes
1
Description
Parent's level of satisfaction from procedure
Timepoint
After completing procedure
Method of measurement
Questionnare
Intervention groups
1
Description
The first participant in the study is randomly assigned to one of the groups based on randomization table (Appendix 2 below), and the next patient will be assigned so.And no one Knows anything about allocation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Bahonar Hospital in Kerman
Full name of responsible person
Dr. Massoud mayel
Street address
National Garden Square. Qarani Street Shahid Bahonar Hospital .
City
kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
masoud.mayel@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
dr. pardakhti
Street address
Tahmasebabad Four Way Deputy of research and technology
City
kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
masoud.mayel@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Massoud mayel
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Emergency Medicine Department - Shahid Bahonar Hospital - Kerman - IRAN
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Fax
Email
masoud.mayel@gmail.co
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Massoud mayel
Position
Assistant Professor استادیار
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
National Garden Square. Qarani Street
City
کرمان
Province
Kerman
Postal code
7613747181
Phone
00+98 34 3223 5011
Fax
Email
masoud.mayel@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Bahonar Educational hospital
Full name of responsible person
Dr. Massoud Mayel
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
میدان باغملی .خیابان قرنی
City
kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Fax
Email
masoud.mayel@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available