Overview

Midazolam and Ketamine Effect Administered Through the Nose for Sedation of Children for Dental Treatment

Status:
Completed
Trial end date:
2016-10-18
Target enrollment:
0
Participant gender:
All
Summary
Randomised clinical trial to test the efficacy, safety and cost-effectiveness of sedatives; masked, controlled, parallel design with three arms, phase 4.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Universidade Federal de Goias
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Treatments:
Ketamine
Midazolam
Pharmaceutical Solutions
Criteria
Inclusion Criteria:

- American Society of Anesthesiologists I (healthy) or II (mild and controlled systemic
disease such as persistent asthma)

- Small risk of airway obstruction (Mallampati less than 2 or tonsillar hypertrophy
occupying less than 50% of the oropharynx)

- No medical history of neurological or cognitive changes

- Absence of facial deformities

- Term birth

- No use of drugs that may impair cognitive functions

- At least two teeth with cavities without pulp involvement, requiring dental
restoration under local anesthesia and rubber dam

Exclusion Criteria:

- Positive or definitely positive behavior (Frankl et al, 1962) in a dental treatment
session conducted by the research team