Comparison of the effects of propofol/fentanyl and propofol/apotel for IV sedation during the dental treatment of 2-6 years old precooperative pediatric patients
Intravenous sedation effect of apotel/Propofol and Fentanyl/propofol on Non-Cooperative 2-6 Years Old Pediatric Dental Patients
Design
Randomized clinical trial, triple blindness, cross control group. Thirty eight 2-6 years old children divide into tow intervention and control groups with flipping a coin. Trial phase is 3
Settings and conduct
Children are randomly assigned to one of two control and case groups. 30 minutes before the start of the treatment 0/5 mg/kg midazolam is given orally to the patient. Group A: 15 mg/kg Apotel and 2 mg/kg propofol in the first session and group F: 1 microgram/kg fentanyl and 2 mg/kg propofol in the first session. In both groups, the order of drug administration is reversed in the second session. Medicines are given to the patient by the anesthesiologist, and the patient, dentist and evaluator are not aware of the composition of the medicine. The pulse oximeter probe is also placed on the child's finger. Dental treatment begins with local anesthesia of lidocaine 2% and epinephrine 1/100,000. The rate of changes in blood oxygen saturation and heart rate, the rate of crying, sleepiness and movement; At the time of venipuncture, local anesthesia injection, 15 minutes and 30 minutes from the start of work, Houpt scale is evaluated and recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria؛ Uncooperative 2-6 year old children, need 2 sessions similar treatment. Exclusion criteria؛ Suffering systemic diseases, common cold.
Success of dental treatment according to Houpt Scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221203056700N1
Registration date:2023-01-28, 1401/11/08
Registration timing:prospective
Last update:2023-01-28, 1401/11/08
Update count:0
Registration date
2023-01-28, 1401/11/08
Registrant information
Name
Maryam Shamsaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2237 0439
Email address
dr.m.shamsaie@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-09, 1401/11/20
Expected recruitment end date
2023-06-10, 1402/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of propofol/fentanyl and propofol/apotel for IV sedation during the dental treatment of 2-6 years old precooperative pediatric patients
Public title
effects of propofol/apotel and propofol/fentanyl on dental sedation of 2-6 years old uncooperative children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
2-6 years old children
Uncooperative
Need to at least two same and symmetric treatment session
ASA 1 health status
Exclusion criteria:
The age under 2 and above 6 years
Cooperative
Lack of similar treatment needs
ASA 2 and more
Age
From 2 years old to 6 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
38
More than 1 sample in each individual
Number of samples in each individual:
2
Each patient gives apotel in one session and fentanyl in other one.
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is done using flipping a coin and the patient is placed in one of groups A or F on that basis
Blinding (investigator's opinion)
Triple blinded
Blinding description
The drug combination is given to the patient by the anesthesiologist. Patient and researcher and evaluator do not know the type and dose of the drug.
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