Effects of oral administration of dexmedetomidine in the control of pain induced by venous sampling in children with ALL: a randomized, double-blind clinical trial.
Design
Using the software, codes A and B will be generated, code A means the application of the dexmedetomidine group and code B means the application of the control group for each person. Finally, the codes will be placed in the sealed envelope and the number of each patient will be written on the envelope. After the arrival of each patient, the doctor will open the envelope and apply the desired treatment.
Settings and conduct
The study is a randomized, double-blind, placebo-controlled clinical trial that will be conducted in the pediatric hematology and oncology department of Bou Ali Sina Medical Education Center.
Participants/Inclusion and exclusion criteria
Children aged 2 to 16 years with ALL in the maintenance treatment phase according to the COG treatment protocol with ASA I-II (American Society of Anesthesiologists) who were hospitalized in the pediatric hematology and oncology department of Bou Ali Sina Medical Education Center and were candidates for blood sampling were included in the study. History of congenital heart disease, intellectual disability, use of neuropsychiatric drugs, use of beta-blockers, history of cardiac arrhythmias, history of recent use of painkillers (within the last 24 hours), recent respiratory infection (within the last month) are excluded from the study.
Intervention groups
In the intervention group, dexmedetomidine was prescribed 30 minutes before sampling through an oral solution at a dose of 1.5 micrograms per kilogram of body weight in fruit juice (apple juice) in a total volume of 5 cc.
Main outcome variables
Evaluating the effectiveness and safety of oral administration of dexmedetomidine in blood sampling in children with leukemia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190804044429N11
Registration date:2024-06-05, 1403/03/16
Registration timing:registered_while_recruiting
Last update:2024-06-05, 1403/03/16
Update count:0
Registration date
2024-06-05, 1403/03/16
Registrant information
Name
Monireh Ghazaeian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8863 6864
Email address
ghazaeianm@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2025-08-12, 1404/05/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Oral Dexmedetomidine effect on pain management in pediatric ALL patients under blood sampling: A randomized, double blind, clinical trial
Public title
Oral Dexmedetomidine effect on pain management in pediatric ALL patients under blood sampling: A randomized, double blind, clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children from 2 to 16 years old
ALL patients
In the phase of maintenance treatment according to the COG protocol
ASA score 1-2
Admitted to the hematology and oncology department of Bou Ali Sina Hospital
Candidate for blood sampling
Exclusion criteria:
Congenital heart disease
Mentally disabled
Use of psychiatric medications
Taking beta blockers
History of arrhythmias
Recent respiratory infection
Age
From 2 years old to 16 years old
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will be done individually. Using the software, codes A and B will be generated, code A means the application of the dexmedetomidine group and code B means the application of the control group for each individual. Finally, the codes will be placed in the sealed envelope and the number of each patient will be written on the envelope. After the arrival of each patient, the doctor will open the envelope and apply the desired treatment.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double_ blind. Outcome elevator and participant are blinded (double blind) and aware from grouping (intervention or placebo)
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Mazandaran University of Medical Sciences
Street address
Ibn Sina hospital, Pasdaran Blvd, Sari town
City
Sari
Province
Mazandaran
Postal code
4816864193
Approval date
2024-04-20, 1403/02/01
Ethics committee reference number
IR.MAZUMS.REC.1403.046
Health conditions studied
1
Description of health condition studied
Acute lymphoblastic leukemia
ICD-10 code
C91.0
ICD-10 code description
Acute lymphoblastic leukemia
Primary outcomes
1
Description
Reducing the intensity of pain and restlessness in children with ALL
Timepoint
During the period of receiving maintenance treatment
Method of measurement
numerical rating scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Half of the patients will receive oral dexmedetomidine in combination with 5 milliliter of apple juice before blood sampling
Category
Treatment - Drugs
2
Description
Control group: Half of the patients will receive 5 milliliter of apple juice before blood sampling
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Bo Ali Sina Hospital, Sari
Full name of responsible person
Monireh Ghazaeian
Street address
Pasdaran Blvd of Bo Ali Sina Hospital, Sari
City
sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3334 3989
Email
ghazaeianm@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Pedram Ebrahimnejad
Street address
Vice chancellor for research, Mazandaran University of Medical Sciences, joybar three-way,sari
City
sari
Province
Mazandaran
Postal code
4817844718
Phone
+98 11 3325 7230
Email
pajhooheshi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Monireh Ghazaeian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Ibn Sina hospital, Pasdaran Blvd, Sari town
City
Sari
Province
Mazandaran
Postal code
4816864193
Phone
+98 11 3334 3989
Email
Ghazaeianm@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Monireh Ghazaeian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Ibn Sina hospital, Pasdaran Blvd, Sari town
City
Sari
Province
Mazandaran
Postal code
4816864193
Phone
+98 11 3334 3989
Email
Ghazaeianm@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Monireh Ghazaeian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Ibn Sina hospital, Pasdaran Blvd, Sari town
City
Sari
Province
Mazandaran
Postal code
4816864193
Phone
+98 11 3334 3989
Email
Ghazaeianm@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data related to initial outcome of the study will be shared
When the data will become available and for how long
The data will be available one year after publication
To whom data/document is available
Academic researchers, medical team and scientific institutes
Under which criteria data/document could be used
Requests for sharing data should be sent to the person responsible for general inquiries
From where data/document is obtainable
Requests for sharing data should be sent to the person responsible for general inquiries
ghazaeianm@gmail.com
What processes are involved for a request to access data/document
Person in charge of scientific study will reply to the requests within 10 days