Appointment and comparison effect of two methods of intravenous sedation include midazolam- ketamine with midazolam- fentanyl in uncooperative children for dental treatment. The patients were disported to the two groups randomized. First group received IV injection of 0.05 mg/kg midazolam and 0.5 mg/kg ketamin every 2 minutes and second group received IV injection of 0.05 mg/kg midazolam and 0.5 microgr/kg fentanyl every 2 minutes. During the operation in both group will given 0.25 mg midazolam if it need, and evaluate the rate of the efficacy of two drug group in control of children during and after of operation. Evaluate the side effect of drug include agitation, fear of the injection, nausea and vomiting too. Evaluated, recorded and analysis the sedation score and work condition by Dental Sedation Teachers Group (DSTG) system every 10 minutes during the operation. After the end of the operation patients looking after the standard observation in recovery and after catch the releasing condition is released by appropriate instruction. The patient is getting under observation by anesthetic proficient during the operation and vital sign, saturation rate of oxygen is getting under observation by pulse oxymetry device. The dentist is doing the local anesthesia injection include lidocain 2% and epinephrin 1/80000 in the location of the operation. The patient study and endorse the testimonial form.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201303144224N22
Registration date:2014-04-28, 1393/02/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-04-28, 1393/02/08
Registrant information
Name
Nasser Kaviani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2858
Email address
kaviani@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Islamic Azad University Khorasgan Branch
Expected recruitment start date
2013-12-06, 1392/09/15
Expected recruitment end date
2014-04-21, 1393/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two method of intravenous sedation in control of uncooperative children for dental treatment
Public title
Comparison of two method of intravenous sedation in control of uncooperative children for dental treatment
Purpose
Treatment
Inclusion/Exclusion criteria
children ASA I,II; age between 4-9 years old; have satisfaction for study; need dental treatment with intravenous sedation; don't have psychological problem; don't have insufficient of renal and liver, and COPD and asthma and epilepsy and insufficient of aura; don't have bad history after dental treatment; don't have allergy to the used medicine.
Age
From 4 years old to 9 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University khorasgan branch,college of dentistry
Street address
Islamic Azad University Khorasgan branch(Isfahan), Arghavanieh, Jey st, Isfahan, Iran
City
Isfahan
Postal code
81551-39998
Approval date
2013-12-02, 1392/09/11
Ethics committee reference number
493007
Health conditions studied
1
Description of health condition studied
child control with dental afride
ICD-10 code
F93.1
ICD-10 code description
Phobic anxiety disorder of child
Primary outcomes
1
Description
sedation score
Timepoint
10 and 20 and 30 and 40 minutes during operation
Method of measurement
observation and completion of questionnaire
Secondary outcomes
1
Description
work condition
Timepoint
10 and 20 and 30 and 40 minutes during operation
Method of measurement
observation and completion of questionnaire
Intervention groups
1
Description
Prescription drug
first group: 0.05 mg/kg midazolam and 0.5 mg/kg ketamin intravenously every 2 minutes from each other befor dental treatment
Category
Treatment - Drugs
2
Description
second group: 0.05 mg/kg midazolam and 0.5 microgr/kg fentanyl intravenously every 2 minutes from each other befor dental treatment.
During the operation in both group will given 0.25 mg midazolam if it need,
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Operating Room of Dental Faculty of University of Medical Sciences
Full name of responsible person
Dr Naser Kaviani
Street address
Dental school, University of Medical Sciences, Darvazeh shiraz,Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research minestiry ofIslamic Azad University of Khorasgan
Full name of responsible person
Dr vahid esfahanian
Street address
Islamic Azad University Khorasgan branch(Isfahan), Arghavanieh, Jey st, Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research minestiry ofIslamic Azad University of Khorasgan
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
Islamic Azad University Khorasgan Branch, College of Dentistry
Full name of responsible person
Sanaz Ashrafi
Position
Student of dentistry
Other areas of specialty/work
Street address
Islamic Azad University Khorasgan branch(Isfahan), Arghavanieh, Jey st, Isfahan, Iran
City
Isfahan
Postal code
81551-39998
Phone
+98 31153540019
Fax
+98 31 1535 4060
Email
sani_ss89@yahoo.com
Web page address
khuisf.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University Khorasgan Branch, College of Dentistry
Full name of responsible person
Sanaz Ashrafi
Position
Student of dentistry
Other areas of specialty/work
Street address
Islamic Azad University Khorasgan branch(Isfahan), Arghavanieh, Jey st, Isfahan, Iran
City
Isfahan
Postal code
81551-39998
Phone
+98 31153540019
Fax
+98 31 1535 4060
Email
sani_ss89@yahoo.com
Web page address
khuisf.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University Khorasgan Branch, College of Dentistry
Full name of responsible person
Sanaz Ashrafi
Position
Student of dentistry
Other areas of specialty/work
Street address
Islamic Azad University Khorasgan branch(Isfahan), Arghavanieh, Jey st, Isfahan, Iran
City
Isfahan
Postal code
81551-39998
Phone
+98 31153540019
Fax
+98 31 1535 4060
Email
sani_ss89@yaoo.com
Web page address
khuisf.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)