UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018237 |
|---|---|
| Receipt number | R000021112 |
| Scientific Title | The effect of midazolam administration for the prevention of emergence agitation in children undergoing dental treatment during general anesthesia |
| Date of disclosure of the study information | 2015/07/07 |
| Last modified on | 2019/01/08 11:15:06 |
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Basic information
Public title
The effect of midazolam administration for the prevention of emergence agitation in children undergoing dental treatment during general anesthesia
Acronym
The effect of midazolam administration for the prevention of emergence agitation
Scientific Title
The effect of midazolam administration for the prevention of emergence agitation in children undergoing dental treatment during general anesthesia
Scientific Title:Acronym
The effect of midazolam administration for the prevention of emergence agitation
Region
| Japan |
Condition
Condition
Dental Phobia
Mental retardation
Classification by specialty
| Dental medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To effect of midazolam administration for the prevention of emergence agitation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The level of agitation and sedation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
0.05mg/kg midazolam
Interventions/Control_2
0.1mg/kg midazolam
Interventions/Control_3
NS 2ml
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
| 12 | years-old | >= |
Gender
Female
Key inclusion criteria
patient undergoing dental treatment during general anesthesia
Key exclusion criteria
cerebral palsy
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mari Kawai |
Organization
Nagasaki University Hospital
Division name
Department of Dental Anesthesiology
Zip code
Address
1-7-1,Sakamoto,Nagasaki-city
TEL
095-819-7714
kawaimari@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mari Kawai |
Organization
Nagasaki University Hospital
Division name
Department of Dental Anesthesiology
Zip code
Address
1-7-1,Sakamoto,Nagasaki-city
TEL
095-819-7714
Homepage URL
kawaimari@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 07 | 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
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 07 | Day |
Last modified on
| 2019 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021112
