Unique ID issued by UMIN | UMIN000014450 |
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Receipt number | 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 17:42:45 |
Study about the efficacy of lorazepam as a premedication for the disabled patients showing serious maladaptive behaviors in dentistry
The efficacy of lorazepam for the intellectually disabled patients
Study about the efficacy of lorazepam as a premedication for the disabled patients showing serious maladaptive behaviors in dentistry
The efficacy of lorazepam for the intellectually disabled patients
Japan |
The intellectual disabled patients
(The patients having a history of showing serious maladaptive behaviors in dentistry within the past one year)
Dental medicine |
Others
NO
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.
Safety,Efficacy
Exploratory
Pragmatic
Phase IV
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.
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.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
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
12 | years-old | <= |
45 | years-old | >= |
Male and Female
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.
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.
50
1st name | |
Middle name | |
Last name | Akiko Shiki DDS, PhD |
Ogata Pediatric Dental Clinic
Dental Anesthesia
1-13-17, Hakata eki-higashi,Hakata-ku,Fukuoka 812-0013,Japan
092-472-2885
ashiki3025@gmail.com
1st name | |
Middle name | |
Last name | Akiko Shiki DDS |
Ogata Pediatric Dental Clinic
Dental Anesthesia
1-13-17, Hakata eki-higashi,Hakata-ku,Fukuoka 812-0013,Japan
092-472-2885
ashiki3025@gmail.com
Ogata Pediatric Dental Clinic
None
Self funding
Matsushima Mental Clinic
NO
医療法人発達歯科会 おがた小児歯科医院(福岡県)
2014 | Year | 07 | Month | 02 | Day |
Unpublished
Terminated
2014 | Year | 06 | Month | 25 | Day |
2014 | Year | 07 | Month | 02 | Day |
2016 | Year | 12 | Month | 31 | Day |
2016 | Year | 12 | Month | 31 | Day |
2014 | Year | 07 | Month | 01 | Day |
2017 | Year | 01 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016738
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