Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT04083105
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
8 Years
Study:
NCT04083105
Study Brief:
Protocol Section:
NCT04083105