UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of midazolam administration for the prevention of emergence agitation in children undergoing dental treatment during general anesthesia
Title of the study (Brief title)	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	Mari Kawai
Organization	Nagasaki University Hospital
Division name	Department of Dental Anesthesiology
Address	1-7-1,Sakamoto,Nagasaki-city
TEL	095-819-7714
Email	kawaimari@nagasaki-u.ac.jp

Public contact
Name of contact person	Mari Kawai
Organization	Nagasaki University Hospital
Division name	Department of Dental Anesthesiology
Address	1-7-1,Sakamoto,Nagasaki-city
TEL	095-819-7714
Homepage URL
Email	kawaimari@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University Hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021112