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