The aim of this study is to compare 2 combinations of etomidate/fentanyl and propofol/fentanyl by intravenous injection in sedation of uncooperative children during dental treatments.
Design
This study was designed as a randomized, crossover and clinical evaluation. Study population: There are 20 children aged 3 to 6 who refer to the hospital fellowship department of Shahid Beheshti Faculty of Dentistry.
Settings and conduct
The present study was carried out in non-cooperative children (Frankel 1 and 2), healthy (ASAI 2-6 years old, referring to the hospital fellowship department of Shahid Beheshti Faculty of Dentistry
Participants/Inclusion and exclusion criteria
Inclusion criteria:
A. Non-cooperative children aged 2-10 (completely negative and negative based on Frankel scale grading) (36)
B. The patient should be in ASA I group.
C. The patient needs to perform at least 2 sessions of similar dental work with local anesthesia.
exclusion criteria
A. Suffering from systemic diseases or having a history of asthma and allergies B. Catching a cold and blocking the respiratory tract during dental treatment C. Existence of any medical advice and orders prohibiting the use of drugs used to induce sedation (existence of any adrenal, liver, kidney failure, drug sensitivities or airway obstruction, etc.)
Intervention groups
The first group is the combination of etomidate, fentanyl and the second group is propofol, fentanyl
Main outcome variables
The consumers of this research are anxious and uncooperative children with decayed teeth for whom it is not possible to perform dental treatment normally in the clinic.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230515058193N1
Registration date:2024-11-22, 1403/09/02
Registration timing:retrospective
Last update:2024-11-22, 1403/09/02
Update count:0
Registration date
2024-11-22, 1403/09/02
Registrant information
Name
Sedighe Mozafar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 9210
Email address
se.mozafar@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-21, 1403/05/31
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the sedative effect of etomidate and propofol in dental treatment of children.
Public title
Comparative study of sedative effects of intravenous administration of etomidate, fentanyl, midazolam drug combination with propofol, fentanyl, midazolam in children's dental treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy children without any background, syndrome and special conditions
Absence of illness at present (cold and presence of nasal and pharyngeal discharge)
Exclusion criteria:
Children with perfect physical health
Age
From 2 years old to 10 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
2
Each participant is examined twice in the study
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling was done in a simple way and classification was done randomly
Blinding (investigator's opinion)
Double blinded
Blinding description
The present study is double-blind and only the anesthesiologist was aware of the process
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid beheshti medical sciences
Street address
Chamran street
City
Tehran
Province
Tehran
Postal code
021-22175350-51
Approval date
2023-01-12, 1401/10/22
Ethics committee reference number
IR.SBMU.DRC.REC.1402.011
Health conditions studied
1
Description of health condition studied
Examining the sedative effect of drugs
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Oxygen saturation
Timepoint
After prescribing the medicine and starting the treatment and every 10 minutes until discharge
Method of measurement
Percent
2
Description
heart beat (RATE)
Timepoint
Before drug administration, after drug administration and starting treatment, and every 10 minutes until discharge
Method of measurement
A number between 60 and 100
Secondary outcomes
1
Description
Anesthetic drugs
Timepoint
When injecting the patient
Method of measurement
MG/KG
Intervention groups
1
Description
In the first group (AB), they underwent sedation in one treatment session with the combination of intravenous drug A: etomidate/fentanyl/midazolam and in the next session with the combination of intravenous drug B: propofol/fentanyl/midazolam.
Category
Treatment - Drugs
2
Description
Intervention group: The second group (BA) was the opposite of the first group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital Fellowship Department of Shahid Beheshti Faculty of Dentistry
Full name of responsible person
Dr.sedighe Mozafar
Street address
Chamran street
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
se.mozafar@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr.falahinejad
Street address
Chamran street
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2241 3897
Email
se.mozafar@gmail.com
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
80
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
Dr.Dedighe Mozafar
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Chamran street
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
22413897 -021
Email
se.mozafar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Sedighe Mozafar
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Vesal st,Italy st
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 8895 9210
Fax
Email
se.mozafar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Sedighe Mozafar
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Vesal st,Italy st
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 8895 9210
Fax
Email
se.mozafar@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
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
A clinical study report will be provided
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
It will be available for researchers working in academic and scientific institutions
Under which criteria data/document could be used
People who use documents to apply for reviews of other people examined in the study, get a positive response to receive the documents
From where data/document is obtainable
o receive documents, to the email address
send a message to se.mozafar@gmail.com.
What processes are involved for a request to access data/document
Documents will be sent within two weeks after sending the message.