BIS (Bispectral Index Score) after sedation with Midazolam and Propofol combined with Remifentanil vs. Ketamine in pediatric dentistry:A randomized clinical trial study
Objectives: a lot of children with caries need immediate and serious dental treatment don’t accept the treatment due to fear of local anesthesia. For optimum result gaining in pediatric dentistry, using sedation seems to be a fair solution.Design: In this clinical study we compared two drug combinations, propoful/midazolam/remifentanile combination versus propoful/midazolam/ketamine to see which one effects better according to Bispectral index scaling system. Setting and conduct:Childs dental treatment will be done by two different combinations of medicine through sedation. Participants including major eligibility criteria:32 agitated and incorporative children between the 3 to 7 years old were collected randomly for the study. Inclusion Criteria: Healthy Systemic Condition; Uncooperative children dentistry operation candidate for sedation; children between 3-7 years old; Exclusion Criteria: The time of sedation more than 45 minutes. Intervention:a Bispectral Index Score sensor is connected to each child and do the sedation with two different combination of medicines.main outcome measures variables: Consciousness and brain activity are measured by the Bispectral index score device connected to the patient.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015042512848N2
Registration date:2015-09-09, 1394/06/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-09-09, 1394/06/18
Registrant information
Name
Dana Tahririan
Name of organization / entity
Dental college, Isfahan University of Medical Sciences, Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 1673 2985
Email address
tahririan@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Isfahan University of Medical Sciences
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2015-06-21, 1394/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
BIS (Bispectral Index Score) after sedation with Midazolam and Propofol combined with Remifentanil vs. Ketamine in pediatric dentistry:A randomized clinical trial study
Public title
Brain activity during sedation under tow anesthesia regimes
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion Criteria:Healthy Systemic Condition; Uncooperative children dentistry operation candidate for sedation; children between 3-7 years old; Exclusion Criteria: The time of sedation more than 45 minutes; accidental problem during the work.
Age
From 3 years old to 7 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Of Dental College, Isfahan University of Medical Sciences
Street address
Isfahan Dental College, Isfahan University of Medical Sciences, HezarJarib Street, Isfahan
City
Isafahan
Postal code
Approval date
2014-03-08, 1392/12/17
Ethics committee reference number
393398
Health conditions studied
1
Description of health condition studied
Mental and behavioural disorders
ICD-10 code
F93.8
ICD-10 code description
Other childhood emotional disorder
Primary outcomes
1
Description
Consciousness and brain activity which can be read through the BIS device connected to the patient.
Timepoint
Every five minute as sedation begins, by a By technician unaware of the topic of the study
Method of measurement
By recording from the BIS device
Secondary outcomes
1
Description
success in sedation
Timepoint
Every ten minute in recovery room by an unaware(topic of strudy and used regime) technician
Method of measurement
DSTG(Dental Sedation Teachers Group)index
Intervention groups
1
Description
0.1µg/kg remifentanile
Category
Diagnosis
2
Description
0.5 mg/kg ketamine
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Medical Science
Full name of responsible person
Street address
Pediatric Part, Isfahan Dental College, Isfahan University of Medical Sciences, Hezar Jarib street, Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Isfahan University of Medical Sciences
Full name of responsible person
Aminallah Tavangar
Street address
Vice Chancellor for Research, Isfahan University of Medical Sciences, Shohadaye Sofe Street
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Isfahan University of Medical 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
Isfahan Dental College, Isfahan University of Medical Sciences
Full name of responsible person
Dr.Dana Tahririan
Position
Asisstant Professor
Other areas of specialty/work
Street address
Pediatric Part, Isfahan Dental College, Isfahan University of Medical Sciences, Hezar Jarib street, Isfahan
City
Isfahan
Postal code
Phone
+98 913 109 7401
Fax
Email
tahririan@dnt.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan Dental College, Isfahan University of Medical Sciences
Full name of responsible person
Dr.Dana Tahririan
Position
DDS, MS
Other areas of specialty/work
Street address
Pediatric Part, Isfahan Dental College, Isfahan University of Medical Sciences, Hezar Jarib street, Isfahan
City
Isafahan
Postal code
Phone
+98 913 109 7401
Fax
Email
tahririan@dnt.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan Dental College, Isfahan University of Medical Sciences
Full name of responsible person
Dr.Dana Tahririan
Position
Other areas of specialty/work
Street address
Pediatric Part, Isfahan Dental College, Isfahan University of Medical Sciences, Hezar Jarib street, Isfahan
City
Isfahan
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)