Nitrous Oxide Prior to Intranasal Midazolam for Moderate Dental Sedation in Pediatric Patients

• Status: Unknown status
• Trial end date: 2021-07-11
• Target enrollment: 0
• Participant gender: All

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 procedures.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital Colorado
• Collaborator: University of Colorado, Denver
• Treatments: Midazolam; Nitrous Oxide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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