To decrease dental work recall in children and minimize the emotional trauma under general anaesthesia, whit used an effective premedication may facilitate a smoother induction of GA.The aim of this study are to determine efficacy dental work recall in children. In this prospective clinical trial, 60 uncooperative children are selected from those are referring for dental work under general anaesthesia. Healthy children (ASAI, ASAII) and aged 4to10 years with refused treatment; these children are extremely uncooperative and anxious. Children are excluded from the study, if they are respiratory unstable, have any hypoxia, arrhythmia or pain in recovery room. Patients are divided in to case and control groups. The case group receives orally 0.5 mg/kg of inject able midazolam mixed with juice, 20 minutes before separation from parents. If the child is not allow venepuncture before induction of GA, inhalational anaesthetic used by combination oxygen, N2O, isofluran are doing. Standard and same monitoring and maintenance of anaesthesia during operation for all children are doing. In recovery room maintaining are performed for all patients. According to the (PADS) scale system and standard protocol. After that, ask about the recall of events from child.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201101054224N9
Registration date:2011-08-23, 1390/06/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-08-23, 1390/06/01
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, Isfahan University of Medical Sciences
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2011-09-20, 1390/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effects of oral Midazolam premedication on recall preoperative process in General Anaesthesia in children dentistry
Public title
Evaluation the effects of oral Midazolam premedication on recall preoperative process under General Anaesthesia in children dentistry
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria:
Systemic Condition: ASAI, ASAII;
Uncooperative children dentistry operation candidate for general anaesthesia;
Exclusion Criteria:
Exist of Hypoxia;
Arrhythmia;
Pain in recovery room;
Agitation;
Nausea
Age
From 4 years old to 10 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan university of Medical Sciences ethical committee
Street address
Isfahan Dental College, Isfahan Medical University, Hezar Jiereeb Street
City
Isfahan
Postal code
Approval date
2010-10-18, 1389/07/26
Ethics committee reference number
390017
Health conditions studied
1
Description of health condition studied
Post operative recall
ICD-10 code
F93.8
ICD-10 code description
Other childhood emotional disorders
Primary outcomes
1
Description
Recall of process and events
Timepoint
Before medication, after anaesthesia
Method of measurement
Filling questionnaire
Secondary outcomes
1
Description
Anaesthetic technique
Timepoint
After medication
Method of measurement
Objective
Intervention groups
1
Description
Drug prescription, orally 0.5 mg/kg inject able midazolam mix with juice
Category
Prevention
2
Description
Placebo Prescription
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Dental College
Full name of responsible person
Sara Nazari
Street address
Shohadaye sofe street
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
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan Dental College- Isfahan Medical University
Full name of responsible person
Dr Naser Kaviani
Position
Doctor of Anesthesia
Other areas of specialty/work
Street address
Shohadaye Sofeh Street
City
Isfahan
Postal code
IRAN
Phone
00983117922858 -009803116687080
Fax
Email
kaviani@dnt.mui.ac.ir
Web page address
www.dentalfear_blogfa.com
Person responsible for updating data
Contact
Name of organization / entity
Isfahan Dental College- Isfahan Medical University
Full name of responsible person
Nasser kaviani
Position
Faculty member
Other areas of specialty/work
Street address
Shohadaye Sofeh Street
City
Isfahan
Postal code
Phone
+98 31 1792 2858
Fax
Email
kaviani@dnt.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)