In this survey we want to study the effects of oral midazolam on tension of children with urinary tract defects during voiding cystourethrography. The key inclusion criteria is to be older than 3 years old the key exclusion criteria is unwillingness of the parents to continue the study. 84 patients with urinary tract defects who are candidate for voiding cystourethrography referring to Tabriz Children's hospital, Tabriz, Iran will be involved and divided into two equal sized groups. In the intervention group children will receive 50mg/kg oral midazolam half an hour before VCUG, and the tension and stress level during the VCUG will be observed and recorded by a nephrologist. Then the patients would be evaluated in terms of voiding dysfunction by the same person. All mentioned measures will be performed for the nonintervention group as well except for the administration of midazolam. Then all the gathered data will be compared between the groups to draw a onclusion.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110257892N2
Registration date:2012-08-09, 1391/05/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-09, 1391/05/19
Registrant information
Name
Anoosh Azarfar
Name of organization / entity
Mashhad University of Medical Sciences, Faculty of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 51 1606 1227
Email address
azarfara@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2012-06-22, 1391/04/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of oral midazolam on tension of children with urinary tract defects during voiding cystourethrography
Public title
The effects of midazolam on voiding cystogram quality
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria : (to be 3 to 12 years old)
Exclusion criteria : (unwillingness of the parents to continue the study)
Age
From 3 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not 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 Tabriz University of medical sciences
Street address
Deputy of resarch,Faculty of medeicne, Tabriz ,East Azarbaujan,Iran
City
Tabriz
Postal code
Approval date
2011-01-22, 1389/11/02
Ethics committee reference number
5/4/8674
Health conditions studied
1
Description of health condition studied
Urinary system disorders
ICD-10 code
N39.9
ICD-10 code description
Disorder of urinary system, unspecified
Primary outcomes
1
Description
Stress level
Timepoint
During the cytography
Method of measurement
Observaion and recording in the questionnaire
2
Description
Voiding dysfunction
Timepoint
During the cystograpy
Method of measurement
Observation by a nephrologist
Secondary outcomes
empty
Intervention groups
1
Description
In intervention group: half an hour before the cystoggraphy Midazolam 50 mg/kg will be administered orally.
Category
Treatment - Drugs
2
Description
In nonintervention group the cyctography will be performed without administeration of Midazolam.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Children's Hospital
Full name of responsible person
Majid Malaki
Street address
Children's hospital, Sheshgelan st.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostad Rahimi
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Daneshgah square
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Majid Malaki
Position
Subspecialist in children's nephrology/Assistant professor
Other areas of specialty/work
Street address
Children's Hospital, Sheshgelan st.
City
Tabriz
Postal code
Phone
+98 41 1526 2261
Fax
Email
madjidmalaki@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Anush Azarfar
Position
Assistant professor, subspecialist in children's nephrology
Other areas of specialty/work
Street address
Children's Hospital, Sheshgelan st.
City
Tabriz
Postal code
Phone
+98 411658413
Fax
Email
azarfara@mums.ac.i
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Hemmati
Position
General physician
Other areas of specialty/work
Street address
Emam Reza hospital, Golgasht avenue
City
Tabriz
Postal code
Phone
Fax
Email
Mehdi.hemmati@rocketmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)