Overview

Nasal Versus Oral Midazolam Sedation in Routine Pediatric Dental Care

Status:
Unknown status
Trial end date:
2020-12-01
Target enrollment:
0
Participant gender:
All
Summary
The general objective of the study is to compare the efficacy of administering midazolam orally as syrup versus nasally with nasal atomizer. The specific objectives are to measure: 1) acceptability of the medication, 2) effect on behavior, 3) time of onset, 4) maximum working time.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Hadassah Medical Organization
Treatments:
Midazolam
Nitrous Oxide
Criteria
Inclusion Criteria:

- healthy children (ASA 1), uncooperative (Frankl 1-210), that needs at least two
similar dental treatments.

Exclusion Criteria:

- enlarged tonsils (Brodsky's grading scale11 +3 = 50-75% airway obstruction, and +4 =
>75% airway obstruction), upper respiratory tract infection or nasal discharge.