The clinical study of local anesthesia injection effects on recovery condition for children under 6 years that they reference to the surgery room of dental school.
The aim of study is supportive care by local anesthesia on recovery in children subsequent treatment of dentistry under general anesthesia. In this study 60 healthy children under 6 years that they candidate for treatment of dentistry are divided in to two groups at random (A control groups and an intervention one). The assessment before action and the method of anesthesia for all done the same. Infiltration of local anesthesia is done in one of the groups while in the other one isn't. Recovery conditions: Includes the time of recovery; Pain and agitation. The children are evaluated and compared in two groups. Entry condition: The children 's parents are explain about entry the study and if they like to cooperate they can complete the special form; The children must be under 6 years; Healthy or ASA I; Assigned to dental treatment for general anesthesia;
Exit condition: Patient with ASA II or more; Blooding disorder; Parents disagreement; Systematic and chronic hepatic and renal disease; The time of general anesthesia less than 60 or more than 90 minutes; Using sedate or sedation drug by the children interfering.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107164224N11
Registration date:2011-09-06, 1390/06/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-09-06, 1390/06/15
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, Esfehan University of Medical Sciences
Expected recruitment start date
2011-03-16, 1389/12/25
Expected recruitment end date
2011-07-09, 1390/04/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The clinical study of local anesthesia injection effects on recovery condition for children under 6 years that they reference to the surgery room of dental school.
Public title
A study of local anesthesia injection effects on recovery condition for children following dentistry under general anesthesia
Purpose
Supportive
Inclusion/Exclusion criteria
Entry condition: The children 's parents are explain about entry the study and if they like to cooperate they can complete the special form; The children must be under 6 years; Healthy or ASA I; Assigned to dental treatment for general anesthesia;
Exit condition: Patient with ASA II or more; Blooding disorder; Parents disagreement; Systematic and chronic hepatic and renal disease; The time of general anesthesia less than 60 or more than 90 minutes; Using sedate or sedation drug by the children interfering.
Age
From 2 years old to 6 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
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 ٍEsfahan University of Medical Science
Street address
Hezar Jarib street, University of Medical Science, Esfahan
City
Esfahan
Postal code
Approval date
2011-04-12, 1390/01/23
Ethics committee reference number
390175
Health conditions studied
1
Description of health condition studied
A study of local anesthetic injection effects on recovery condition for children following general anesthesia
ICD-10 code
f10,f11,f1
ICD-10 code description
Mental and behavioural disorders due to psychoactive substance use
Primary outcomes
1
Description
Recovery condition
Timepoint
Evry ten minutes
Method of measurement
Obsevation
Secondary outcomes
1
Description
Discharge time
Timepoint
Evry ten minutes
Method of measurement
Observation and examination
Intervention groups
1
Description
Intervention groups: In this study 60 healthy children are divided in to two groups at random. The assessment before action and the method of anesthesia for all done the same. Injection of local anesthesia like Lidocain 2%(vial 1.8 c.c) that used once or three more in 5 minutes is done in intervention groups.
Category
Behavior
2
Description
Control groups: In this study 60 healthy children are divided in to two groups at random. The assessment before action and the method of anesthesia for all done the same. Injection of local anesthesia like Lidocaine is not done in control groups.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Surgery room, Dentistry college, University Medical of Science, Esfahan
Full name of responsible person
Nasser Kaviani
Street address
Dental college, Esfahan University Medical of Science, Esfahan
City
Esfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Esfehan University of Medical Sciences
Full name of responsible person
Amin Alla Tavangar
Street address
Esfahan dental college, Hezar Jarib street, University Medical of Science, Esfahan, IRAN
City
Esfahan
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, Esfehan 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan dental school
Full name of responsible person
Nasser Kaviani
Position
Anesthesiologist, Assisstant professor
Other areas of specialty/work
Street address
Dental school, University Medical of Sciences, Hezar Jarib street, Esfahan, IRAN
City
Esfahan
Postal code
Phone
+98 31 1792 2851
Fax
Email
Kaviani@dnt.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfahan dental school
Full name of responsible person
Masod Gheisary
Position
Dentistry collegian
Other areas of specialty/work
Street address
ِِِDental school, University Medical of Sciences, Hezar Jarib street, Esfahan, IRAN
City
Esfahan
Postal code
Phone
+98 31 1792 2858
Fax
Email
Md_gheisary@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)