Intravenous sedation effect of Ketamine/Propofol and Ketamine/Midazolam on Non-Cooperative Pediatric Dental Patient 2-6 Years Old
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 assigned to one of two groups of cases and controls. 30 minutes before starting treatment 0.3Mg / kg midazolam is given orally to the patient as premedication. Group A: first session 2 mg/kg ketamine and 2 mg/kg Propofol and group B: first session 2 mg/kg Ketamine and 0.2 mg/kg midazolam by intravenous injection They receive treatment from the beginning. In both groups, the order of medication in the second session is reversed. The drugs are given to the patient by the person who is unaware of the dose of the drug and the patient is not aware of the composition of the drug. The pulse oximeter probe is also placed on the child's finger to record the amount of changes in blood oxygen(SpO2) and pulse rate(PR) obtained in the form of each patient. Dental treatment begins with local anesthesia of 2% lidocaine and 1/100,000 epinephrine. Rate of crying, drowsiness and movement; at the time of anesthesia injection and 15 minutes and 30 minutes from the start of work with the 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.
Intervention groups
Ketamine 2mg/kg+ Propofol 2mg/kg and Ketamine 2mg/kg+ Midazolam 0.2 mg/kg
Main outcome variables
Success of dental treatment according to Houpt Scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090506001882N10
Registration date:2021-03-08, 1399/12/18
Registration timing:prospective
Last update:2021-03-08, 1399/12/18
Update count:0
Registration date
2021-03-08, 1399/12/18
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
2021-04-09, 1400/01/20
Expected recruitment end date
2021-07-06, 1400/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the IV sedation effect of ketamine/propofol and ketamine/ midazolam in dental treatments of 2-6 years old uncooperative children
Public title
Sedative effect of ketamine / propofol and ketamine / midazolam on non-cooperating children in pediatric dentistry
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Be in the negative group be 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:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is conducted using Coin toss with patient placed in one of the two groups of A or B 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 dose of the drug.
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Institute of Dental Sciences, Shahid Beheshti University of Medical Sciences