The comparison study of midazolam and promethazine premedication in MRI outpatients undergone general anesthesia in children, imaging ward of children's medical center 2020
Determining and comparing the effect of oral pretreatment of promethazine and midazolam on sedation of outpatients under MRI with anesthesia in children referred to imaging ward
Design
Clinical trial with control group, with parallel groups, double blind, randomized, on 116 patients, two groups of 58 people. The randomization method of this study will be block randomization. Thus, using random generators, 4 blocks consisting of promethazine and midazolam groups will be formed. The process of assigning patients to the two study groups will be performed by a trained nurse (outside the research team).
Settings and conduct
The study population is children referred to the medical center hospital and the sample of children referred to the clinic is the MRI ward of the Children's medical center hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria will be all patients aged 1 to 10 years old and ASA class 1 and 2. Exclusion criteria: dissatisfaction of parents to participate in the project; genetic and congenital diseases; history of allergy to the studied drugs; behavioral disorders; use of psychiatric drugs and any mental disorders in the child; use sleeping pills before visiting; patients with ASA grade 3 and above; non-Persian speaking family.
Intervention groups
The first group will be given 0.3 mg / kg midazolam (with 20 cc of sugar water) half an hour before separation and the second group will be given 1 mg / kg of promethazine (with 20 cc of sugar water).Their vital signs will then be recorded (including heart rate, blood pressure, respiratory rate).
Main outcome variables
Duration of stay in recovery; sedation score according to Ramsay; maximum PAED as the orthogonal delirium score; satisfaction of recovery nurses with RN satisfaction Score; existence of nausea and vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200521047530N2
Registration date:2020-09-29, 1399/07/08
Registration timing:prospective
Last update:2020-09-29, 1399/07/08
Update count:0
Registration date
2020-09-29, 1399/07/08
Registrant information
Name
Nima Nazari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6147 2569
Email address
n-nazari@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-10-23, 1400/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison study of midazolam and promethazine premedication in MRI outpatients undergone general anesthesia in children, imaging ward of children's medical center 2020
Public title
The comparison study of midazolam and promethazine premedication in MRI outpatients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients aged 1 to 10 years old
ASA class 1 and 2
Patients who have referred to the Pediatric Medical Center Hospital for outpatient MRI under anesthesia.
Exclusion criteria:
Dissatisfaction of parents to participate in the project
Genetic and congenital diseases
History of allergy to the studied drugs
behavioral disorders
Use of psychiatric drugs and any mental disorders in the child
Use sleeping pills before visiting
Patients with ASA grade 3 and above
Non-Persian speaking family
Age
From 1 year old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
116
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method of this study will be block randomization. Thus, using random generators, 4 blocks consisting of promethazine and midazolam groups will be formed. The process of assigning patients to the two study groups will be performed by a trained nurse (outside the research team) and the researchers in this study will not be aware of the allocation process(allocation concealment).
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient himself is unaware of which category he falls into And what kind of anesthetic is given to him. The researcher is also unaware of what kind of medicine is given to each patient. The process of assigning patients to the two study groups will be performed by a trained nurse (outside the research team) and the researchers in this study will not be aware of the allocation process.The data will be collected by a researcher who is unaware of the classification of patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Keshvarz Blvd- Qods St- Central building of Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417653911
Approval date
2020-07-11, 1399/04/21
Ethics committee reference number
IR.TUMS.CHMC.REC.1399.088
Health conditions studied
1
Description of health condition studied
patients candidate for MRI
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sedation criteria
Timepoint
Measure immediately after entering recovery
Method of measurement
RAMSAY criteria score
2
Description
Delirium emergence score
Timepoint
Measure immediately after entering recovery
Method of measurement
PAED score
Secondary outcomes
1
Description
Recovery time
Timepoint
After entering the recovery
Method of measurement
Interval from admission to recovery ward until discharge
2
Description
Sedation score
Timepoint
After entering the recovery
Method of measurement
Ramsay Score
3
Description
delirium emergence score
Timepoint
After entering the recovery
Method of measurement
PAED score
4
Description
Nurses' satisfaction
Timepoint
After entering the recovery
Method of measurement
RN satisfaction score
5
Description
Nausea and vomiting
Timepoint
After entering the recovery
Method of measurement
View
6
Description
Bronchospasm and laryngospasm
Timepoint
After entering the recovery
Method of measurement
Observation of symptoms and auscultation
Intervention groups
1
Description
Intervention group: Promethazine/ Half an hour before separation, 1 mg / kg promethazine (with 20 cc of sugar water) will be given.
Category
Treatment - Drugs
2
Description
Control group: midazolam/ Half an hour before separation, 0.3 mg / kg midazolam (with 20 cc of sugar water) will be given.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's medical center Hospital
Full name of responsible person
Nima Nazari
Street address
Keshavarz Blvd- Gharib St- Children's medical center Hospital
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6147 2353
Fax
+98 21 6693 0024
Email
cmcpr@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Keshavarz Blvd- Ghods St- Central Building Of Tehran University of Nedical Sciences
City
Tehran
Province
Tehran
Postal code
1417653911
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Nima Nazari
Position
Assistant professor of anesthesiology department
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Keshavarz Blvd- Gharib St- Children's medical center Hospital
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
00982161479
Fax
+98 21 6693 0024
Email
nima.nazari1366@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nima Nazari
Position
Assistant professor of Anesthesiology department
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Keshavarz Blvd- Ghrib St- Children's medical center hospital
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
00982161479
Fax
+98 21 6693 0024
Email
nima.nazari1366@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nima Nazari
Position
Assistant professor of anesthesiology department
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Keshavarz Blvd- Ghrib St- Childern's medical center Hospital
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
00982161479
Fax
+98 21 6693 0024
Email
nima.nazari1366@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
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
Yes - There is 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
Title and more details about the data/document
The data will be published in general and in the form of a general report.
No personal information or names of study participants will be disclosed.
When the data will become available and for how long
The results will be available from 1400 and after the results are published.
To whom data/document is available
Access will be available to everyone.
Under which criteria data/document could be used
Access will be available to everyone. It will be possible for all people to use the results and data.
From where data/document is obtainable
email:nima.nazari1366@gmail.com
Dr. Nima Nazari/ Assistant Professor if Anesthesiology- Tehran University of medical sciences
What processes are involved for a request to access data/document
The request for data submission will be sent to the mentioned email.The data will then be available to everyone.