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Recruitment status Terminated
Unique ID issued by UMIN UMIN000014450
Receipt No. R000016738
Scientific Title Study about the efficacy of lorazepam as a premedication for the disabled patients showing serious maladaptive behaviors in dentistry
Date of disclosure of the study information 2014/07/02
Last modified on 2017/01/03

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Basic information
Public title Study about the efficacy of lorazepam as a premedication for the disabled patients showing serious maladaptive behaviors in dentistry
Acronym The efficacy of lorazepam for the intellectually disabled patients
Scientific Title Study about the efficacy of lorazepam as a premedication for the disabled patients showing serious maladaptive behaviors in dentistry
Scientific Title:Acronym The efficacy of lorazepam for the intellectually disabled patients
Region
Japan

Condition
Condition The intellectual disabled patients
(The patients having a history of showing serious maladaptive behaviors in dentistry within the past one year)
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The intelectually disabled patients often cannot be able to enter the operating room, or to sit down on a dental chair because of their extreme anxiety or tension, in dentistry. A purpose of this study is researching the efficacy of lorazepam as a premedication for these patients showing maladaptive behaviors in dentistry.
Lorazepam is administered during preoperative 2 days and on the morning of the operative day, with a dose of 3mg per day in divided doses per oral. A single dose is 1mg.

Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes The efficacy of lorazepam is assessed on the day of general anesthesia or procedure of dentistry, about 2 hours after the last administration of lorazepam.
Key secondary outcomes The anticipated maladaptative behaviors (such as inability of coming to a clinic, inability of entering the operating room, inability of sitting down on a dental chair, or running away ect.) are scored according to the degree of serious level.
The scored points corresponding to maladaptative behaviors after lorazepam premedication, are compared with those in the past hitory.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oral administration of lorazepam with a dose of 3mg divided in 3 times per day for preoperative 2 days, and a single dose of 1mg on the operative morning 2 hours prior to a general anesthesia or procedure in dentistry
Interventions/Control_2
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
12 years-old <=
Age-upper limit
45 years-old >=
Gender Male and Female
Key inclusion criteria 1)Intellectually disabled subjects who have a history of difficulty in a dental prcedure including a general anesthesia induce because of their serious maladaptative behavior, within the past one year.
2)Physical constitution of the subjects correspond to the adult size, and therefore a control of behavior with a medicine is essential.
3)Guardians of the subjects consent and cooperate to this study.
Key exclusion criteria 1)Subjects who are contraindicated to benzodiazepine drugs (acute narrow-angle glaucoma, nuero-muscle disease).
2)Consultation is needed about an indication of lorazepam, to a regular doctor if a subject is administered other psychotropic drugs.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akiko Shiki DDS, PhD
Organization Ogata Pediatric Dental Clinic
Division name Dental Anesthesia
Zip code
Address 1-13-17, Hakata eki-higashi,Hakata-ku,Fukuoka 812-0013,Japan
TEL 092-472-2885
Email ashiki3025@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Akiko Shiki DDS
Organization Ogata Pediatric Dental Clinic
Division name Dental Anesthesia
Zip code
Address 1-13-17, Hakata eki-higashi,Hakata-ku,Fukuoka 812-0013,Japan
TEL 092-472-2885
Homepage URL
Email ashiki3025@gmail.com

Sponsor
Institute Ogata Pediatric Dental Clinic
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Matsushima Mental Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 医療法人発達歯科会 おがた小児歯科医院(福岡県)

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 02 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 Terminated
Date of protocol fixation
2014 Year 06 Month 25 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 02 Day
Last follow-up date
2016 Year 12 Month 31 Day
Date of closure to data entry
2016 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 07 Month 01 Day
Last modified on
2017 Year 01 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016738

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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