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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032540
Receipt No. 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

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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
Email 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
Email bokuaiji@dpc.agu.ac.jp

Sponsor
Institute Aichi Gakuin University
Department of anaesthesiology, School of Dentistry
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037110

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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