UMIN-CTR Clinical Trial

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

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

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

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.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Ogata Pediatric Dental Clinic

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Matsushima Mental Clinic

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人発達歯科会　おがた小児歯科医院（福岡県）

Date of disclosure of the study information

2014

Year

07

Month

02

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2014

Year

07

Month

01

Day

Last modified on

2017

Year

01

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016738