Safety and Efficacy of Intranasal Dexmedetomidine

• Status: Unknown status
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to evaluate the efficacy and safety of intranasal dexmedetomidine when used in combination with oral midazolam and/or nitrous oxide for moderate sedation during pediatric outpatient dental procedures.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bon Secours Pediatric Dental Associates
• Treatments: Dexmedetomidine; Midazolam; Nitrous Oxide

Criteria

Inclusion Criteria:

1. Patients aged from 3 through 6 years of age.

2. Patients who are appropriate for in-office sedation for dental care.

Exclusion Criteria:

1. Patients younger than 3 or older than 6 years of age.

2. History of failed sedation.

3. BMI greater than 30.

4. Patients weighing less than 10 kgs.

5. Patients weighing more than 25 kgs.

6. Patients who are deemed unsuitable for sedation by a physician at their preoperative history and physical.

7. Patients who are deemed unsuitable for in-office sedation in accordance with Bon Secours policy (American Society of Anesthesiologists [ASA] Classification greater than II, Mallampati score greater than 2, Brodsky tonsil score greater than 2).

8. Patients with sleep apnea.

9. Patients with a history of an unfavorable reaction to DEX or clonidine.

10. Patients with pulmonary hypertension.