Status:
UNKNOWN
Nitrous Oxide Prior to Intranasal Midazolam for Moderate Dental Sedation in Pediatric Patients
Lead Sponsor:
Children's Hospital Colorado
Collaborating Sponsors:
University of Colorado, Denver
Conditions:
Dental Anxiety
Pain
Eligibility:
All Genders
3-8 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to assess the effectiveness of nitrous oxide/oxygen administration in reducing the discomfort of intranasal midazolam administration for moderate sedation for dental proce...
Detailed Description
This study will determine the effectiveness of two different concentrations of nitrous oxide for reducing the pain of intranasal midazolam when given for subjects already planned for moderate sedation...
Eligibility Criteria
Inclusion
- Patients selected to undergo moderate sedation at the Children's Hospital Colorado Dental Clinic
- Subject must have visited the dental clinic within 4 months of their sedation appointment for a regular dental examination
- Subject must have a well-child visit with their primary care physician within the last 12 months prior to their sedation appointment
- Child must fall between the ages of 3 to 8 years old
- Child must be healthy, American Society of Anesthesiologists scale I or II
- Children under 4 years will be asked to count and explain the instrument before enrollment.
Exclusion
- Upper respiratory illness (URI) symptoms less than 4 weeks before sedation appointment
- American Society of Anesthesiologists scale III or IV
- Children with special needs including intellectual disability, congenital malformations, chronic conditions
- Chronic lung disease
- Cyanotic heart disease
- Children with anatomic airway abnormalities or moderate to severe tonsillar hypertrophy
- Any contraindications to nitrous oxide use including: Chronic obstructive pulmonary diseases, current upper respiratory tract infections, recent middle ear disturbance/surgery, severe emotional disturbances or drug-related dependencies, previous treatment with bleomycin sulfate, methylenetetrahydrofolate reductase (MTHFR) deficiency, cobalamin (Vitamin B12) deficiency
- Allergy or hypersensitivity to nitrous oxide or midazolam
Key Trial Info
Start Date :
July 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 11 2021
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04083105
Start Date
July 12 2019
End Date
July 11 2021
Last Update
September 10 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045