Comparison of three methods of verbal speaking intranasal injection of midazolam and ketamine intranasal injection in control of pain and stress associated with peripheral venous thrombosis in children
Comparison of three methods of verbal speaking intranasal injection of midazolam and ketamine intranasal injection in control of pain and stress associated with peripheral venous thrombosis in children
Design
The design of the study is a randomized clinical trial. The randomization method is blocked. Patients will be randomly divided into 4 groups based on 20 blocks. The sample size for each study group is 25.
Settings and conduct
All patients referred to the Ali Asghar Hospital, who needed peripheral venous will be enrolled. Patients will be randomly divided into 4 groups based on 20 blocks. The sample size for each study group is 25. A total of 100 patients will be examined. Data analyzer will be blind.
Participants/Inclusion and exclusion criteria
All patients referred to the Ali Asghar Hospital, who suffered from bronchiolitis will be enrolled. Inclusion criteria: patients over 1year, Parental consent for the child to participate in the project. Exclusion criteria: Immunodeficiency, Down syndrome, Chronic heart and pulmonary disease.
Intervention groups
Intervention groups:
1- Intranasal injection of Midazolam 0.2 mg / kg, 20 minutes before the procedure with the MAD.
2- Intervention group: Intranasal injection of Ketamine 5 mg/kg, 20 minutes before the procedure with the MAD.
3- Use verbal talk to calm children, before the procedure.
Control group: No special action is taken before the procedure.
Main outcome variables
The number of pulses,The number of pulses, Breath rate, The severity of pain after the procedure, The amount of sedation.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151003024317N8
Registration date:2019-09-28, 1398/07/06
Registration timing:prospective
Last update:2019-09-28, 1398/07/06
Update count:0
Registration date
2019-09-28, 1398/07/06
Registrant information
Name
Mahdi Rezai
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8868 6772
Email address
rezaei.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-02, 1398/07/10
Expected recruitment end date
2020-03-15, 1398/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of three methods of verbal speaking intranasal injection of midazolam and ketamine intranasal injection in control of pain and stress associated with peripheral venous thrombosis in children
Public title
Controling of pain and stress associated with peripheral venous thrombosis in children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age over one year
Parental consent for the child to participate in the project
Exclusion criteria:
Immunodeficiency
Down syndrome
Chronic heart and pulmonary disease
Age
From 1 year old to 10 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to two groups. In order to randomize, a random block method will be used. For this purpose, we formed blocks with 20 person. In each block, 15 individuals will be in intervention groups (5 from each group) and 5 will be in control group. A total of 5 blocks will be considered for sample size.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-02-24, 1397/12/05
Ethics committee reference number
IR.IUMS.REC.1398.011
Health conditions studied
1
Description of health condition studied
Peripheral vein in children
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Saturation of oxygen
Timepoint
10 minutes after the procedure
Method of measurement
Pulse Oximetry
2
Description
The number of pulses
Timepoint
10 minutes after the procedure
Method of measurement
Based on patient records
3
Description
Breath rate
Timepoint
10 minutes after the procedure
Method of measurement
Based on patient records
4
Description
The severity of pain after the procedure
Timepoint
10 minutes after the procedure
Method of measurement
Observational Scale of Behavioral Distress-Revised
5
Description
The amount of sedation
Timepoint
10 minutes after the procedure
Method of measurement
Observational Scale of Behavioral Distress-Revised
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intranasal injection of Midazolam 0.2 mg / kg, 20 minutes before the procedure with the MAD.
Category
Treatment - Drugs
2
Description
Intervention group: Intranasal injection of Ketamine 5 mg/kg, 20 minutes before the procedure with the MAD.
Category
Treatment - Drugs
3
Description
Intervention group: Use verbal talk to calm children, before the procedure.
Category
Behavior
4
Description
Control group: No special action is taken before the procedure.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Asghar Hospital
Full name of responsible person
Shabahang Jafarnejad
Street address
Ali Asghar Children's Hospital, Shaheed Dastgerdi Street (Zafar),
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2222 2042
Email
aach@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abbas Motevallian
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 8670 2503
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Shabahang Jafarnejad
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
shabahangjafarnejad@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shabahang Jafarnejad
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
shabahangjafarnejad@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shabahang Jafarnejad
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
shabahangjafarnejad@yahoo.com
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
Not applicable
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