Comparative evaluation of the sedative effects of Intra-Venous Propofol / Fentanyl combination Vs. Ketamine / Midazolam combination for uncooperative 2-6 year old children undergoing dental procedures.
Comparative evaluation of the sedation efficacy, effects and safety of intra-Venous infusion of Propofol / Fentanyl combination versus Ketamine / Midazolam combinations in a group of uncooperative 2-6 year old children undergoing dental procedures.
Design
Double blind , randomized, cross over clinical trial carried out on 24 patients
Settings and conduct
This study will be performed on uncooperative children referred to the pediatric dentistry fellowship department of Shahid Beheshti dental faculty who need two similar dental procedures.
They will be divided into groups AB and BA randomly. In group AB, in the first treatment session, drugs regimen A (Propofol/Fentanyl) and in the second treatment session, drugs regimen B (Ketamine/Midazolam) will be used for sedation. In group BA, the use of sedative drugs, will be reversed.
All physiologic and behavioral parameters will be recorded during various stages of treatment by a trained assistant. The choice of drug regimen, medication of drugs and control of the patient 's vital signs will be done by an anesthesiologist without the knowledge of the treating dentist and the parents
Participants/Inclusion and exclusion criteria
Inclusion criteria:
A- Uncooperative 2-6 years old children
B- Patient in ASA I
C- Patient requires at least two similar dental procedures with local anesthesia
Exclusion criteria:
A-Patient with systemic disorder or allergic/asthmatic history
B-Patient with a cold or airway obstruction during dental procedure
C-Patient with medical advice to stop the sedative drugs
Intervention groups
Propofol/Fentanyl versus Ketamine/Midazolam will be used to behavioral control of uncooperative children undergoing dental procedures
Main outcome variables
Determining an effective and appropriate drug regimen with minimal side effects between Propofol/Fentanyl and Ketamine/Midazolam for sedation in dental procedures of uncooperative children
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211123053154N1
Registration date:2022-04-03, 1401/01/14
Registration timing:retrospective
Last update:2022-04-03, 1401/01/14
Update count:0
Registration date
2022-04-03, 1401/01/14
Registrant information
Name
Mohammad Esmaeilzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4496 9962
Email address
dr.m.esmaeilzadeh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-05, 1400/10/15
Expected recruitment end date
2022-02-04, 1400/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of the sedative effects of Intra-Venous Propofol / Fentanyl combination Vs. Ketamine / Midazolam combination for uncooperative 2-6 year old children undergoing dental procedures.
Public title
Comparative evaluation of the sedative effects of Intra-Venous Propofol / Fentanyl combination Vs. Ketamine / Midazolam combination for uncooperative children undergoing dental procedures.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Uncooperative 2-6 years old children
Patient is in ASA I
Patient requires at least two similar dental procedures with local anesthesia
Exclusion criteria:
Patient with systemic disorder or allergic/asthmatic history
Patient with a cold or airway obstruction during dental procedure
Patient with medical advice to stop the sedative drugs
Age
From 2 years old to 6 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided in two groups AB and BA, in which the AB group prescribed drug A and then drug B. The order of drug administration in group BA will be reversed
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients and the therapist are not aware of sedative medication regimen during dental procedures. The anesthesiologist and the care team will only be aware about that
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Unit 5, N0.2, The first dead end, Shahid Sharifi Ave, Abazar Blvd, Ayatollah Kashani Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1471735576
Approval date
2021-03-07, 1399/12/17
Ethics committee reference number
IR.SBMU.DRC.REC.1399.131
Health conditions studied
1
Description of health condition studied
Dental treatment of uncooperative children under sedation conditions
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
the level of child's cooperation
Timepoint
Before dental treatment, during dental treatment and after dental treatment
Method of measurement
Observation and based on Houpt Behavioral Scale
2
Description
Heart Rate
Timepoint
Before dental treatment, during dental treatment and after dental treatment
Method of measurement
Pulse oximeter device made by the Alborz company
3
Description
Atrial oxygen saturation or Spo2
Timepoint
Before dental treatment, during dental treatment and after dental treatment
Method of measurement
Pulse oximeter device made by the Alborz company
Secondary outcomes
empty
Intervention groups
1
Description
In group AB, combination of Fentanyl (dose: 1μgr/kg) and Propofol (dose: 2 mg/kg) will be injected in the intervention phase and the first session of dental treatment for sedation induction. Propofol injection will continue (dose: 150μgr/kg/H) for sedation maintenance
Category
Treatment - Drugs
2
Description
In group BA, combination of Ketamine (dose: 2mgr/kg) and Midazolam (dose: 0.2 mg/kg) will be injected in the intervention phase and the first session of dental treatment for sedation induction.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric dentistry Fellowship Department of Shahid Beheshti Dental Faculty
Full name of responsible person
Mohammad Esmaeilzadeh
Street address
Unit 5, No2, The first dead end, Shahid Sharifi Ave, Abazar Blvd, Ayatollah Kashani Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1471735576
Phone
+98 21 4496 9962
Email
dr.m.esmaeilzadeh@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin zarghi
Street address
School of Dentistry, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd, Daneshgah Square, Evin, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2203 2387
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
40
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
Mohammad Esmaeilzadeh
Position
Assistance professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Unit 5, No2, the first dead end, Sharifi Ave, Abazar Blvd, Ayatollah Kashani Highway, tehran
City
Tehran
Province
Tehran
Postal code
1471735576
Phone
+98 21 4496 9962
Email
dr.m.esmaeilzadeh@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Esmaeilzadeh
Position
Assistance professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Unit 5, No2, The first dead end, Sharifi Ave, Abazar Blvd, Ayatollah Kashani Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1471735576
Phone
+98 21 4496 9962
Email
dr.m.esmaeilzadeh@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Esmaeilzadeh
Position
Assistance professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Unit 5, No2, The first dead end, Sharifi Ave, Abazar Blvd, Ayatollah Kashani Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1471735576
Phone
+98 21 4496 9962
Email
dr.m.esmaeilzadeh@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Observance of ethical standards
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
Only data on drug outcome will be provided and the patients' personal information will be strictly confidential
When the data will become available and for how long
Immediately after the end of the research and presentation of the result or through the publication of an article
To whom data/document is available
Researchers working in academic and scientific institutes
Under which criteria data/document could be used
Researchers working in academic and scientific institutes and presenting valid C.Vs
From where data/document is obtainable
Applicants can obtain access to the data by submitting a request to the moderator 's email or phone number in due time.
Moderator : Mohammad Esmaeilzadeh
Email: dr.m.esmaeilzadeh@sbmu.ac.ir
phone number: 0098 912 3467984
What processes are involved for a request to access data/document
After submitting the applicant 's request via the mentioned email or phone number and Provide a valid C.V stating that she/he is working in reputable domestic or foreign scientific research institutes, the applicant will be able to access the information of this research within one week after submitting the request, if she/he has the requisite conditions.