Determining the effectiveness of chloral hydrate syrup formulation on childrens sedation
Design
Randomised,blind clinical trial with intervention and control groups on 110 patients. the method of generating random numbers will be done in R software version 4.0.1
Settings and conduct
This study takes place in two phases.
The first phase is preparation pharmaceutical form of syrup in the department of pharmaceutics Faculty of Pharmacy:
1- Pharmaceutical material is prepared from reliable sources and identification tests are performed on this.
2- Syrup containing chloral hydrate in two medicinal doses is made.
3- Primary physical and chemical tests done for the suitable formulation.
4- Syrup is measured of appropriate dosage, taste and viscosity.
5- syrup is poured into appropriate containers and labeled.
The second phase of drug administration and measuring the effect and side effects of the drug:
Non-cooperative children who came to Dr. Mohammad Kermanshahi Hospital for any procedures of echocardiography, CT scan, electrocardiography, electroencephalography, MRI, etc., were prescribed chloral hydrate with the hospital formulation or the researcher's formulation to calm them down. Then, the time of taking the medicine until falling asleep and from the time of falling asleep until the child wakes up is recorded by the doctor.
Participants/Inclusion and exclusion criteria
children aged 6 months to 6years need sedation for diagnostic examinations who do not have background neurological disease
Intervention groups
Intervention group: in the control group, chloral hydrate with the hospital formulation is prescribed for children, and in the test group, chloral hydrate with the researcher's formulation is prescribed for the children.
Main outcome variables
Effective time of the drug
sleep duration
Respiratory problems
QT interval in the bar
Nausea and vomiting
diarrhea
confusion
restlessness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240630062282N1
Registration date:2024-10-04, 1403/07/13
Registration timing:retrospective
Last update:2024-10-04, 1403/07/13
Update count:0
Registration date
2024-10-04, 1403/07/13
Registrant information
Name
Poria Moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3555 6644
Email address
poria.pediatrics@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-09, 1403/05/19
Expected recruitment end date
2024-09-09, 1403/06/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the sedation effect of new chloral hydrate formulation in comparison with common formulations in children under diagnostic procedures
Public title
Effectiveness of the chloral hydrate in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All outpatients or inpatients at Dr. Mohammad Kermanshahi Hospital who need diagnostic procedures
Exclusion criteria:
Background brain diseases
Dissatisfaction of parents
Age
From 6 months old to 6 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Participants in this study are selected through convenience sampling. In this way, qualified patients will be included in the study process if they wish. Then people are divided into two groups A (control group) and group B (test group). For this division, the method of generating random numbers will be done in R software version 4.0.1 by a statistician.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants are prescribed the same medicine at the same time without knowing what kind of medicine they are taking. The additives in each sachet are the same. Also, nurses and researchers who are responsible for recording information are not given information about the type of medicine.
Placebo
Not used
Assignment
Parallel
Other design features
None
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Parrastar
City
Kermanshah
Province
Kermanshah
Postal code
193685274
Approval date
2024-05-12, 1403/02/23
Ethics committee reference number
IR.KUMS.MED.REC.1403.140
Health conditions studied
1
Description of health condition studied
Sedation of uncooperative children in medical examinations
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The time of taking the medicine until falling asleep and from the time of falling asleep until the child wakes up is recorded by the doctor. After the child regains consciousness, complications such as breathing problems, QT interval in the ECG, nausea, diarrhea, vomiting, confusion and restlessness caused by the use of the drug are checked for the next day.
Timepoint
After the child regains consciousness, complications such as breathing problems, QT interval in the ECG, nausea, diarrhea, vomiting, confusion and restlessness caused by the use of the drug are checked for the next day.
Method of measurement
Measurements are made with a researcher-made checklist.
Secondary outcomes
1
Description
The main consequence of the drug is the lack of proper cooperation of the child due to the unpleasant taste of the current homemade solutions and digestive irritations during the continued use of the drug.
Timepoint
Relaxation is done by the researcher. Then all clinical signs are checked for the next day.
Method of measurement
The measurement tool is a researcher-made checklist
Intervention groups
1
Description
Intervention group: In the intervention group, chloral hydrate with the researcher's formulation is prescribed for children.
Category
Treatment - Drugs
2
Description
Control group: in the control group, chloral hydrate with hospital formulation is prescribed for children.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Mohammad Kermanshahi Hospital
Full name of responsible person
Pouria Moradi
Street address
Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
123658947
Email
poria.pediatrics@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Pouria Moradi
Street address
Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
123698547
Email
poria.pediatrics@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Pouria Moradi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
123654899
Phone
+98 83 3725 2563
Email
poria.pediatrics@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Pouria Moradi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
1236548899
Phone
+98 83 3569 7425
Email
poria.pediatrics@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Pouria Moradi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
132689547
Phone
+98 83 3586 9325
Email
poria.pediatrics@gmail.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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
None
When the data will become available and for how long
5 years
To whom data/document is available
Researchers
Under which criteria data/document could be used
Research plan
From where data/document is obtainable
/
What processes are involved for a request to access data/document
Apply through the university approved ethics committee