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

Status unconfirmed · Phase 4

Conditions studied: Dental Anxiety, Pain

In brief

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.

Key facts

Study ID

NCT04083105

Run by

Children's Hospital Colorado

People needed

150

Starts

2019-07-12

Expected to finish

2021-07-11

Last updated by the study team

2019-09-10

Who can join

Age: 3 and older, up to 8. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Children's Hospital Colorado — Aurora, Colorado, United States (enrolling)

Full record on ClinicalTrials.gov

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