Objectives: Fear and anxiety of some children in dentistry lead to problem that they don't have successful treatment. Because of the necessarily of dental treatment in anxiety and uncooperative children in this study we want to comparing sedation of different drugs and use them in children sedation center. Design: This is double blind randomized, clinical trial study. Setting and conduct and Participants including major eligibility criteria: 32 anxiety children of ages 6-8 that referring to sedation center, treatment needs only on left side of upper jaw evaluated in 2 groups. Intervention: Intravenous conscious sedation in first group with Midazolam/Propofol and in second group with Ketamin/Propofol is injected. Main outcome measures (variables): Sedation score of patient in 4 different times, during dental treatment and operating conditions at the end of the treatment, according to dental sedation teacher group(DSTG) is measured. data analyzed with spss, Mann-Whitney, will cocson and fridman tests.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203124224N19
Registration date:2013-05-04, 1392/02/14
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-05-04, 1392/02/14
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
Vice chancellor for Research of Isfahan university of medical sciences،
Isfahan dental school، Hezar Jarib street، Isfahan، Iran.
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2013-08-22, 1392/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing and comparing of Midazolam/Propofol and Ketamin/Propofol intravenouses sedation in anxiety children for dental treatment
Public title
Assessing and comparing of 2 different intravenouses sedation drugs in anxiety children for dental treatment
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion Criteria: Children ages 6-8؛ Uncooperative 1negetive in Frankel grading؛ No specific disease؛ ASA I؛ No need to extraction؛ Treatment needs only on left side of upper jaw؛ No contraindication of sedation.
Exclusion criteria: Emergency event during study؛ Dental treatment more than 45 minutes.
Age
From 6 years old to 8 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)
Double 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 Isfahan university of medical science
Street address
Dental school، University of medical scienses، Hezar Jerib st، Isfahan
City
Isfahan
Postal code
Approval date
2012-12-09, 1391/09/19
Ethics committee reference number
391306
Health conditions studied
1
Description of health condition studied
Dental Anxiety
ICD-10 code
F-40
ICD-10 code description
Phobic anxiety disorders
Primary outcomes
1
Description
Sedation grade
Timepoint
In 4 different times during dental treatment
Method of measurement
According to DSTG score
Secondary outcomes
1
Description
Operating conditions
Timepoint
One time at the end of the dental treatment
Method of measurement
DSTG score
Intervention groups
1
Description
Admistartion1 drug regime to1 patients groups:
1- Midazolam/Propofol(Midazolam 0.01mg/kg only one time at the beginning of the dental treatment throughout IV injection and after 5 minutes Propofol drug 0.05mg/kg with infusion pomp system throughout IV injection during the whole dental treatment up to 45 minutes)
Category
Treatment - Drugs
2
Description
Admistartion1 drug regime to1 patients groups:
1- Ketamin/Propofol(Ketamin 0.05mg/kg only one time at the beginning of the dental treatment throughout IV injection and after 5 minutes Propofol drug 0.05mg/kg with infusion pomp system throughout IV injection during the whole dental treatment up to 45 minutes)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental school of Isfahan university of medical science
Full name of responsible person
dr. Mina Shahtoosi
Street address
Pediatric center، Isfahan dental school، Isfahan university of medical science
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research of Isfahan university of medical sciences
Full name of responsible person
Mr Tavangar
Street address
Dentistry school، Hezar Jarib street، Isfahan
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 of 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
Dental school، Isfahan university of medical science
Full name of responsible person
Mina Shahtoosi
Position
Post graduate student of pediatric dentistry
Other areas of specialty/work
Street address
Dentistry school، Hezar Jarib street، Isfahan
City
Isfahan
Postal code
Phone
+98 31 1792 2891
Fax
Email
kaviani@dnt.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental school of Isfahan university of medical science
Full name of responsible person
Mina Shahtoosi
Position
Post graduate student of pediatric dentistry
Other areas of specialty/work
Street address
Dentistry school، Hezar Jarib street، Isfahan
City
Isfahan
Postal code
Phone
+98 31 1792 2891
Fax
Email
kaviani@dnt.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dental school of Isfahan university of medical science
Full name of responsible person
Mina Shahtoosi
Position
Post graduate student of pediatric dentistry
Other areas of specialty/work
Street address
Dentistry school، Hezar Jarib street، Isfahan
City
Isfahan
Postal code
Phone
+98 31 1792 2891
Fax
Email
kaviani@dnt.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)