UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study about the efficacy of lorazepam as a premedication for the disabled patients showing serious maladaptive behaviors in dentistry
Title of the study (Brief title)	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	Akiko Shiki DDS, PhD
Organization	Ogata Pediatric Dental Clinic
Division name	Dental Anesthesia
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	Akiko Shiki DDS
Organization	Ogata Pediatric Dental Clinic
Division name	Dental Anesthesia
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 06 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000016738