Comparing of Propofol/Ketorolac/Apotel with Propofol/Fentanyl IV Sedation in Dental Treatments of 2-6 Years Old Uncooperative Children.
Design
Randomized clinical trial, triple blindness, cross control group. Twenty 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 placed in one of two study(A) and control(B) groups. Thirty minutes before the start of treatment, oral midazolam( 0.5 mg/kg) is given to the child as a premedication in all sessions. In group A, in the first session, intravenous Propofol/Ketorolac/Apotel (1mg/kg, 0.5mg/kg and 20mg/kg respectively) and in the second session intravenous Propofol/ Fentanyl(1mg/kg and 1µg/kg respectively) combination is administered by the anesthesiologist. In group B, the order of drug administration is reversed to that of group A. The patient, the therapist and the evaluator do not know the type of sedative drug. Then the dental treatment is performed with 2% lidocaine anesthesia injection. Throughout each session, SpO2 oxygen saturation and heart rate are recorded during the intravenous injection of drugs, after anesthesia injection, every 15 minutes during treatment and during discharge. The degree of sedation is done by evaluating the amount and quality of sedation based on the Houpt criteria, parameters SPO2 and Heart Rate. Side effects of drugs including nausea, vomiting, behavioral changes in recovery and 24 hours after treatment are reviewed and compared.
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.
Intervention groups
2mg/kg Propofol+ 0.5mg/kg Ketorolac+ 20mg/kg Apotel and 1mg/kg Propofol+1µg/kg Fentanyl
Main outcome variables
Success of dental treatment according to Houpt Scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090506001882N11
Registration date:2023-01-22, 1401/11/02
Registration timing:prospective
Last update:2023-01-22, 1401/11/02
Update count:0
Registration date
2023-01-22, 1401/11/02
Registrant information
Name
Masoud Fallahinejad Ghajari
Name of organization / entity
Facualty of Dentistry, Shahid Beheshti University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2240 3010
Email address
masfalnegh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-04, 1401/11/15
Expected recruitment end date
2023-06-12, 1402/03/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of propofol/ketorolac/Apotel with propofol / Fentanyl IV sedation in dental treatments of 2-6 years old uncooperative children
Public title
Evaluation of propofol / ketorolac / Apotel sedation with intravenous propofol / fentanyl in dental treatment of uncooperating children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Be in the negative group of Frankel's behavioral classification.
Requires at least 2 similar treatment sessions .
Be in the ASAI group.
Be 2 to 6 years old.
Exclusion criteria:
Suffering Systemic Disease.
Colds during in treatment session.
Non-prescription medication including allergies and treatment needs different from protocol
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:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is done by flip a Coin, tap or line and the patients stay on of the groups A or B.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The drug combination is given to the patient by the anesthesia technician. Patient and researcher and evaluator do not know the 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 Organization Committee in Biomedical Researches, Institute of Dental Research
Street address
Shahid Beheshti University, Daneshjoo Blv., Evin
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2022-05-24, 1401/03/03
Ethics committee reference number
IR.SBMU.DRC.REC.1401.027
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition