Since VCUG is an offensive method that is unpleasant and stressful to children and parents. The aim of this study was to compare the effects of injection Midazolam and oral Chloral hydrate for decreasing stress and increasing cooperating children in VCUG. For this purpose among referral patients from nephrologist to Amir Kabir hospital 150 children selected randomly and divided to three groups. Initially 30 minuets before test midazolam was injected to first group, oral Chloral hydrate was given to second group and was not given drugs to third group. Unlike routine VCUG process that not use of sedation, in this study two above drugs were used. Then a questionnaire to measure the child's cooperation during the test, ease of separation of children from parents, residual urinary volume and adverse drug reactions by resident based on observations of children's behavior during testing project was completed and the results of groups were compared and investigated. In the following the conditions of study are mentioned: Entrance general conditions to Study including: children from 2-12 years old both male & female؛ Children with indication VCUG؛ children with ASA 1 or 2؛ obtaining the informed consent from parents or guardian of children To participate in the study and Exclusion general conditions from Study including: History of systemic chronic diseases such as Renal failure, Respiratory disease and etc؛ history of narcotic abuse؛ history sensitivity to midazolam or chloral hydrate؛ history chronic psychiatric disease including: ADHA, Anxiety, Depression, psychos and Metal retardation
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016041927494N1
Registration date:2017-03-04, 1395/12/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-04, 1395/12/14
Registrant information
Name
Mahdi Aghagoli
Name of organization / entity
Arak Medical University
Country
Iran (Islamic Republic of)
Phone
+98 86 3313 3145
Email address
dr.safi@arak-mu.ac.ir
Recruitment status
Recruitment complete
Funding source
Medical university of ARAK
Expected recruitment start date
2016-02-16, 1394/11/27
Expected recruitment end date
2017-02-15, 1395/11/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Review and Comparison of sedative effect in using of chloral hydrate and midazolam on children under voiding cystourethrogram
Public title
Review and Comparison of sedative effect in using of chloral hydrate and midazolam on children under voiding cystourethrogram
Purpose
Supportive
Inclusion/Exclusion criteria
Entrance general conditions to Study: children from 2 - 12 years old both male & female؛ Children with indication VCUG؛ children with ASA 1 or 2؛ obtaining the informed consent from parents or guardian of children To participate in the study
Exclusion general conditions from Study: History of systemic chronic diseases such as Renal failure, Respiratory disease and etc؛ history of narcotic abuse؛ history sensitivity to midazolam or chloral hydrate؛ history chronic psychiatric disease including: ADHA, Anxiety, Depression, psychos and Metal retardation.
Age
From 2 years old to 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak Medical University
Street address
Enghelab Square
City
Arak Medical University, Sardasht St, Enghelab Sq, Arak
Postal code
Approval date
2016-02-15, 1394/11/26
Ethics committee reference number
IR.ARAKMU.REC.1394.318
Health conditions studied
1
Description of health condition studied
Vesico uretro reflux
ICD-10 code
Q62.7 , N
ICD-10 code description
Congenital vesico-uretero-renal reflux
Primary outcomes
1
Description
Sedation
Timepoint
On time with study
Method of measurement
Visit & question from parents
Secondary outcomes
empty
Intervention groups
1
Description
Without Drug
Category
Treatment - Drugs
2
Description
Chloralhydrate 0/5 cc/kg. Oral. Singledose
Category
Treatment - Drugs
3
Description
Midazolam 100/150 mcg/kg. IM. single dosel
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr.Safi sonography clinic
Full name of responsible person
Dr.Safi
Street address
Floor 9, Amirkabir medical complex, Shariati Sq, Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences
Full name of responsible person
Dr.Rafiee
Street address
Arak Medical University, Technology and Research department of Payambar azam university
City
Arak
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, Arak 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
Arak Medical University
Full name of responsible person
Dr.Aghagoli
Position
Resident
Other areas of specialty/work
Street address
Arak Medical University, Sardasht Av, Enghelab Sq, Arak
City
Arak
Postal code
Phone
+98 86 3222 4291
Fax
Email
aghagoli.mehdi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak Medical University
Full name of responsible person
Dr.Safi
Position
Radiologist
Other areas of specialty/work
Street address
Arak Medical University, Sardasht Av, Enghelab Sq, Arak
City
Arak
Postal code
Phone
+98 86 3224 9952
Fax
Email
dr.safi@arak-mu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak Medical University
Full name of responsible person
Dr.Aghagoli
Position
Resident
Other areas of specialty/work
Street address
Arak Medical University, Sardasht Av, Enghelab Sq, Arak
City
Arak
Postal code
Phone
+98 86 3222 4291
Fax
Email
aghagoli.mehdi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)