Comparison of Nasal Midazolam and Ketamine Effects in Different Doses on Relaxation of Non-Cooperative pediatric Dental patient 3-6 Years Old
Design
Randomized clinical trial, triple blindness, cross control group.
Twenty 3-6 years old children divide into tow intervention and control groups with flipping a coin.
Settings and conduct
Children are randomly assigned to one of two groups of controls and cases. Group A: The first session, they received 4mg/kg midazolam with 4mg/kg ketamine and group B: The first session, midazolam received 0.5mg/kg with 3mg/kg ketamine 15 to 20 minutes before the start of treatment. In both groups, the order of drug administration is reversed in two sessions. The drugs are given to the patient by a person who does not know the dose of the drug and the patient is not aware of the drug composition. 15 to 20 minutes before treatment, the drug is emptied through a syringe into the nose of children. After observing the symptoms sedation , the child is transferred to the dental chair. The pulse oximeter probe is also placed on the child's finger to record the amount of changes in blood oxygen and pulse rate obtained in the form of each patient. Dental treatment begins with the use of local anesthesia 2% lidocaine with epinephrine 1/100000.The amount of crying, drowsiness, and movement; At the time of IV, anesthesia and 10 and 20 minutes of onset are assessed and recorded based on the Houpt rating scale.
Participants/Inclusion and exclusion criteria
Inclusion criteria ؛Uncooperative 3-6 year old children, need 2 sessions similar treatment.
Inclusion 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:IRCT20090506001882N9
Registration date:2020-10-10, 1399/07/19
Registration timing:retrospective
Last update:2020-10-10, 1399/07/19
Update count:0
Registration date
2020-10-10, 1399/07/19
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
2020-03-10, 1398/12/20
Expected recruitment end date
2020-06-20, 1399/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Title Comparison of Nasal Midazolam and Ketamine Effects in Different Doses on Relaxation of Non-Cooperative pediatric Dental patient 3-6 Years Old
Public title
Evaluation of the combined effect of nasal midazolam/ketamine on sedation of 3-6 years non-cooperative 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 3 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 3 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 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
Parallel
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
Street address
5th floor,Dental School, Blv Daneshjoo, Evin
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2020-01-15, 1398/10/25
Ethics committee reference number
IR.SBMU.DRC.REC.1398.212
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
Primary outcomes
1
Description
Conscious sedation
Timepoint
Every 15 minutes
Method of measurement
Houpt scale
Secondary outcomes
1
Description
SpO2
Timepoint
Every 15 minutes
Method of measurement
pulse oxymeter
Intervention groups
1
Description
The combination of 0.4 mg/kg midazolam (5 mg/cc , Darupakhsh Co., Iran) + 4 mg/kg ketamine (50 mg/ccThe combination of 4 mg / kg midazolam (5 mg/cc, Darupakhsh Co., Iran) + 4 mg/kg ketamine (50 mg/cc, Rotexmedica Co., Germany) is sprinkled into the patient's nostril.
Category
Treatment - Drugs
2
Description
The combination of 0.5 mg/kg midazolam (5 mg/cc , Darupakhsh Co., Iran) + 3 mg/kg ketamine (50 mg/ccThe combination of 4 mg / kg midazolam (5 mg/cc, Darupakhsh Co., Iran) + 4 mg/kg ketamine (50 mg/cc, Rotexmedica Co., Germany) is sprinkled into the patient's nostril.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Dental School
Full name of responsible person
Dr. Masoud Fallahinejad Ghajari
Street address
Evin, Daneshjo Blvd, Shahi Beheshti Dental School
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2241 3897
Email
masfalnegh@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Evin, Daneshjo Blvd, Shahid Beheshti university of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۹۸۳۹۹۶۳۱۱۳
Phone
+98 21 2243 9780
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
100
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
Masoud Fallahinejad Ghajari
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Evin, Daneshjo Blvd, Shahid Beheshti university of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۹۸۳۹۶۳۱۳
Phone
+98 21 2240 3080
Email
masfalnegh@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mostafa Mohaveri
Position
Fellowship
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Evin, Daneshjo Blvd, Shahid Beheshti university of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۹۸۳۹۶۳۱۱۳
Phone
+98 21 2240 3050
Email
mohaveri@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Masoud Fallahinejad Ghajari
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Evin, Daneshjo Blvd, Shahid Beheshti university of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۹۸۳۹۶۳۱۱۳
Phone
+98 21 2240 3080
Email
masfalnegh@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available