Safety and Efficacy of Intranasal Dexmedetomidine

Status unconfirmed · Phase 4

Conditions studied: Safety and Efficacy of Intranasal Dexmedetomidine

In brief

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.

Key facts

Study ID

NCT02985697

Run by

Bon Secours Pediatric Dental Associates

People needed

100

Starts

2017-01-01

Expected to finish

2018-06-01

Last updated by the study team

2016-12-07

Who can join

Age: 3 and older, up to 6. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients aged from 3 through 6 years of age.
• Patients who are appropriate for in-office sedation for dental care.

You may not qualify if…

• Patients younger than 3 or older than 6 years of age.
• History of failed sedation.
• BMI greater than 30.
• Patients weighing less than 10 kgs.
• Patients weighing more than 25 kgs.
• Patients who are deemed unsuitable for sedation by a physician at their preoperative history and physical.
• 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).
• Patients with sleep apnea.
• Patients with a history of an unfavorable reaction to DEX or clonidine.
• Patients with pulmonary hypertension.

Where it is running

• Bon Secours Pediatric Dental Associates — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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