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Study about the efficacy of lorazepam as a premedication for the disabled patients showing serious maladaptive behaviors in dentistry

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000014450
Enrollment
50
Registered
2014-07-02
Start date
2014-07-02
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The intellectual disabled patients (The patients having a history of showing serious maladaptive behaviors in dentistry within the past one year)

Interventions

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 proce

Sponsors

Ogata Pediatric Dental Clinic
Lead Sponsor
Matsushima Mental Clinic
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactAkiko Shiki DDS

Ogata Pediatric Dental Clinic Dental Anesthesia

ashiki3025@gmail.com092-472-2885

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026