UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005243 |
|---|---|
| Receipt number | R000005994 |
| Scientific Title | Establishment of safe and reliable sleep induction for children in urologic examination |
| Date of disclosure of the study information | 2011/03/14 |
| Last modified on | 2013/04/19 08:48:50 |
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Basic information
Public title
Establishment of safe and reliable sleep induction for children in urologic examination
Acronym
Establishment of safe and reliable sleep induction for children in urologic examination
Scientific Title
Establishment of safe and reliable sleep induction for children in urologic examination
Scientific Title:Acronym
Establishment of safe and reliable sleep induction for children in urologic examination
Region
| Japan |
Condition
Condition
Children who need sedation for urolgral examination
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establishment of safe and reliable sleep induction for children
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of saccessful sleep induction
Key secondary outcomes
Difference on side effect among the methods for sleep induction
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
GroupA:
administration of TRICLORYL Syrup(Triclofos Sodium)(80mg/kg) and ESCRE suppository (Choral hydrate)(50mg/kg)
Interventions/Control_2
GroupB:
ESCRE suppository (Choral hydrate)(50mg/kg)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| 4 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients less than 4 years old who undergo ezamination under sedation
2. Patients whose guardian(s) aguree to participate in this study
Key exclusion criteria
1.Patients who are judged improper to participate in this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimihiko Moriya |
Organization
Hokkaido University Hospital
Division name
Department of Renul and Genitourinary surgery
Zip code
Address
Kita 14, Nishi 5,Kita-ku Sapporo,Hokkaido,japan
TEL
011-706-5966
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kimihiko Moriya |
Organization
Hokkaido University Hospital
Division name
Department of Renul and Genitourinary surgery
Zip code
Address
Kita 14 ,Nishi 5,Kita-ku Sapporo,Hokkaido,japan
TEL
011-706-5966
Homepage URL
k-moriya@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Renul and Genitourinary surgery Hokkaido University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
| 2012 | Year | 12 | Month | 28 | Day |
Date trial data considered complete
| 2012 | Year | 12 | Month | 28 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | Month | 14 | Day |
Last modified on
| 2013 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005994
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
