UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032540 |
|---|---|
| Receipt number | R000037110 |
| Scientific Title | Comparative study on oral administration and nasal administration of preanesthetic medication to patients with cleft lip and palate |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2021/02/01 13:43:10 |
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Basic information
Public title
Comparative study on oral administration and nasal administration of preanesthetic medication to patients with cleft lip and palate
Acronym
Comparative study on oral administration and nasal administration of preanesthetic medication to patients with cleft lip and palate
Scientific Title
Comparative study on oral administration and nasal administration of preanesthetic medication to patients with cleft lip and palate
Scientific Title:Acronym
Comparative study on oral administration and nasal administration of preanesthetic medication to patients with cleft lip and palate
Region
| Japan |
Condition
Condition
paediatric patients with cleft lip and palate
Classification by specialty
| Anesthesiology | Oral surgery | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will clarify whether oral administration of midazolam or intranasal administration is effective as preanesthetic medication for children.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Sedative effect
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral administration of midazolam
Interventions/Control_2
Nasal administration of midazolam
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
| 1 | years-old | <= |
Age-upper limit
| 10 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Paediatric or child patient with cleft lip and palate
Key exclusion criteria
Paediatric or child patient without cleft lip and palate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Okuda |
Organization
Aichi Gakuin University
Division name
Department of anaesthesiology, School of Dentistry
Zip code
4648651
Address
2-11, Suemori-dori, Chikusa-ku, Nagoya, Aichi
TEL
0527592111
bokuaiji@dpc.agu.ac.jp
Public contact
Name of contact person
| 1st name | Aiji |
| Middle name | |
| Last name | Sato |
Organization
Aichi Gakuin University
Division name
Department of anaesthesiology, School of Dentistry
Zip code
4648561
Address
2-11, Suemori-dori, Chikusa-ku, Nagoya, Aichi
TEL
0527592111
Homepage URL
bokuaiji@dpc.agu.ac.jp
Sponsor or person
Institute
Aichi Gakuin University
Department of anaesthesiology, School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
Aichi Gakuin University
Department of anaesthesiology, School of Dentistry
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Gakuin University School of Dentistry IRB
Address
1-100 Kusumotocho, Chikusaku,Nagoya, Aichi,464-8650,Japan
Tel
052-751-2561
bokuaiji@dpc.agu.ac.jp
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
愛知学院大学歯学部附属病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 01 | 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
| 2018 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 10 | Day |
Last modified on
| 2021 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037110
