In this double blind randomized controlled trial, 20 uncooperative 3-6 year old children with scorers 1,2 Frankle and ASA 1,2 health condition that need at least 2 treatment session after taking written informed consent divide into 2 groups randomly.Group 1 take combination of 10mg/kg ketamine+ 0.5mg/kg midazolam as intranasal and group 2 take the same combination as oral in fist session.Both groups receive the alternate treatment protocol at their second session.The rate of sedation and behavior assessing do by Houpt criteria and pulse oxymeter beginning, 15 and 30 minutes respectively. Also the parent consent, practitioner, side effects of sedation, recovery time ,drowsiness at home assess. Collected data were analyzed using Wilcoxon and paired-t test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201305101882N3
Registration date:2014-06-26, 1393/04/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-06-26, 1393/04/05
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
All costs of research will be provided by shahid Beheshti University of Medical Sciences, Dental Science Research Center .
Expected recruitment start date
2012-03-19, 1390/12/29
Expected recruitment end date
2013-06-26, 1392/04/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Intranasal midazolam/ketamine sedation of 3-6 year old uncooperative dental patients
Public title
sedative effect of intranasal ketamine/midazolam on 3-6 year old children behavior in pediatric dentistry
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1-Frankle 1,2 uncooperative child
2-ASA 1,2 healthy child
3-Needs to at least 2 treatment session
Exclusion criteria:
1- Nasal obturation
2- Respratory infection
3-Tonsile hypertrophy
4-Macroglosia
Age
From 3 years old to 6 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Dental School, Buliv. Daneshjoo, Evin
City
Tehran
Postal code
Approval date
2012-07-09, 1391/04/19
Ethics committee reference number
17th session
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F98-F90
ICD-10 code description
F13
Primary outcomes
1
Description
Sleeping
Timepoint
After effect of drug, 15 and 30 minutes
Method of measurement
Observation and Houpt Scale
2
Description
Crying
Timepoint
After effect of drug, 15 and 30 minutes
Method of measurement
Observation and Houpt Scale
3
Description
Movement
Timepoint
After effect of drug, 15 and 30 minutes
Method of measurement
Observation and Houpt Scale
4
Description
Overall Behavior
Timepoint
After effect of drug, 15 and 30 minutes
Method of measurement
Observation and Houpt Scale
Secondary outcomes
1
Description
Heart Rate
Timepoint
Befor treatment, after effect of drug, 15and 30 minutes
Method of measurement
Pulse oxymeter
2
Description
Spo2
Timepoint
Befor treatment, after effect of drug, 15and 30 minutes
Method of measurement
Pulse oxymeter
Intervention groups
1
Description
First visit
Case group: Intranasal
10mg/kg ketamine+ 0.5mg/kg midazolam
Control group: Oral
10mg/kg ketamine+ 0.5mg/kg midazolam
Category
Treatment - Drugs
2
Description
Second visit
Control group: Intranasal
10mg/kg ketamine+ 0.5mg/kg midazolam
Case group: Oral
10mg/kg ketamine+ 0.5mg/kg midazolam
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
Dental school, Daneshjoo BUlivrd., Evin
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dental Research Center,Research Institute of Dental sciences
Full name of responsible person
Dr. Masoud Fallahinejad Ghajari
Street address
Dental school, Daneshjoo BUlivrd., Evin
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dental Research Center,Research Institute of Dental sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Research Dental Center
Full name of responsible person
Dr.AA Soleymani
Position
Pedodontist
Other areas of specialty/work
Street address
Dental school, Daneshjoo BUlivrd., Evin
City
Tehran
Postal code
1983963113
Phone
+98 21 2241 3897
Fax
Email
asoleimani@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research Dental Center, Institute Research Dental Sciences
Full name of responsible person
Dr. Masoud Fallahinejad Ghajari
Position
Pedodontist/Associated Professor
Other areas of specialty/work
Street address
Dental school, Daneshjoo BUlivrd., Evin
City
Tehran
Postal code
Phone
+98 21 2240 3080
Fax
Email
masoudfallah36@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti Dental School
Full name of responsible person
Dr. Masoud Fallahinejad Ghajari
Position
Pedodontist/Associate Professor
Other areas of specialty/work
Street address
Dental school, Daneshjoo BUlivrd., Evin
City
Tehran
Postal code
Phone
+98 21 2240 3080
Fax
Email
masoudfallah36@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)