Comparative study of dexmedetomidine-fentanyl vs. midazolam-ketamine in sedation in children undergoing bone marrow biopsy
Design
This study is a single blind clinical trial with a control group performed on 70 patients. stratified block randomization will be used for randomization.
Settings and conduct
This study will be done at Mofid Children's Hospital in Tehran in patients who are candidates for bone marrow biopsy.Patients will be divided into two groups.The first group will receive 2 micrograms / kg of dexmedetomidin plus 1 microgram / kg of fentanyl, and the second group (intervention) will receive 1 mg / kg of ketamine plus 0.1 mg / kg of midazolam. Sedation Score , Mean arterial Blood pressure, Heart rate, immediately before prescribing, 2, 5, 10, 15 minutes after prescribing the drug will be recorded in two groups and compared with each other.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children 2 to 6 years of age have ASA I and ASA II classes that are candidates for bone marrow biopsy.Exclusion criteria: congenital heart disease, respiratory disease, productive cough, fever, wheezing or crackles , Refusal of parents to continue cooperating in the project.
Intervention groups
The control group will receive 0.1 mg / kg intrevenous midazolam plus 1 mg / kg intravenous ketamine.The intervention group will be given 1 microgram / kg of intravenous fentanyl plus 2 micrograms / kg of intravenous dexmedetomidine.
Main outcome variables
Sedation Score; Mean Arterial Pressure; Heart rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160301026866N11
Registration date:2020-06-23, 1399/04/03
Registration timing:registered_while_recruiting
Last update:2020-06-23, 1399/04/03
Update count:0
Registration date
2020-06-23, 1399/04/03
Registrant information
Name
Amir Shafa
Name of organization / entity
Isfahan University of Medical Sciences, Imam hossein Hospital
Country
Iran (Islamic Republic of)
Phone
+98 31 3627 2655
Email address
amir_shafa@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-07-20, 1399/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of dexmedetomidine-fentanyl vs. midazolam-ketamine in sedation in children undergoing bone marrow biopsy
Public title
Comparative study of dexmedetomidine-fentanyl vs. midazolam-ketamine in sedation in children undergoing bone marrow biopsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children 2 to 6 years of age
ASA I and ASA II classes
, bone marrow biopsy candidates
Exclusion criteria:
Congenital heart and respiratory disease
productive cough
fever
wheezing or cracking in the lungs
parental withdrawal from the project
Age
From 2 years old to 6 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by method stratified block randomization.All blocks are the same size.The size of each block is 5 people.The first 5 people involved in intervention 1 are in block 1 and the second 5 people who are in the second intervention are in block 2. And so it repeats.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is single blind and Patients do not know how to be in groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences, Ethics comitte
Street address
Shahid Beheshti University of Medical Sciences, Yaman Ave, Chamran Highway,
City
Tehran
Province
Tehran
Postal code
1546815514
Approval date
2020-05-30, 1399/03/10
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.138
Health conditions studied
1
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sedation Score
Timepoint
Immediately before prescribing the drug, 2,5,10,15 minutes after drug administration
Method of measurement
Ramsay Scale
2
Description
Mean Arterial Blood pressure
Timepoint
Immediately before prescribing the drug, 2, 5 ,10,15 minutes after drug administration
Method of measurement
Anesthesia monitoring device
3
Description
Heart Rate
Timepoint
Immediately before prescribing the drug, 2, 5,10,15 minutes after drug administration
Method of measurement
Anesthesia monitoring device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Sedation with 2 micrograms / kg fentanyl plus 2 micrograms / kg dexmedetomidine intravenously
Category
Treatment - Drugs
2
Description
Control group: sedation with 0.1 mg / kg midazolam plus 1 mg / kg ketamine intravenously.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofid Hospital
Full name of responsible person
Amir Shafa
Street address
Mofid Hospital, Shariati Ave
City
Tehran
Province
Tehran
Postal code
1546815514
Phone
+98 21 2222 7021
Email
shafa_amir@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zargi
Street address
Shahid beheshti University of Medical Sciences, Yaman Ave, Shahid chamran Highway
City
Tehran
Province
Tehran
Postal code
1546815514
Phone
+98 21 2243 9331
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amir Shafa
Position
Fellowship Residency
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Mofid Hospital, Shariati Ave
City
Tehran
Province
Tehran
Postal code
1546815514
Phone
+98 21 2222 7021
Email
shafa_amir@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amir Shafa
Position
Fellowship Residency
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shariati St , Mofid Hospital
City
Tehran
Province
Tehran
Postal code
1546815514
Phone
+98 21 2222 7021
Email
shafa_amir@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amir Shafa
Position
Fellowship Residency
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Mofid Hospital, Shariati Ave
City
Tehran
Province
Tehran
Postal code
1546815514
Phone
+98 21 2222 7021
Email
shafa_amir@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after people have not been identified
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Access is free for all researchers
Under which criteria data/document could be used
An official request should be sent from the research institute.
From where data/document is obtainable
Send email to Amir Shafa: shafa_amir@yahoo.com
What processes are involved for a request to access data/document