Recruiting

Nitrous Oxide with Midazolam

Sponsor:

Children's Hospital Colorado

Code:

NCT04083105

Conditions

Dental Anxiety

Pain

Eligibility Criteria

Sex: All

Age: 3 - 8

Healthy Volunteers: Not accepted

Interventions

Nitrous Oxide

Midazolam

Study Details

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 procedures.

Conditions

Dental Anxiety

Pain

Study ID

NCT04083105

Start date

Jul 12, 2019

Status verified date

Sep, 2019

Completion date

Jul 11, 2021

Anticipated

Primary completion date

Jul 11, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 8

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 30% Nitrous Oxide with Midazolam

30 percent nitrous oxide/70 percent oxygen will be administered for 5 minutes prior to intranasal midazolam.

experimental: 70% Nitrous Oxide with Midazolam

70 percent nitrous oxide/30 percent oxygen will be administered for 5 minutes prior to intranasal midazolam.

Interventions

Nitrous Oxide

Nitrous oxide will be given prior to determine if it reduces pain from intranasal midazolam administration. Nitrous oxide is a minimal sedation drug used as an inhaled gas to reduce anxiety and produce anxiolysis and analgesia during dental procedures.

Midazolam

Intranasal midazolam will be given after nitrous oxide administration.

Primary outcome measure

  • Heart rate [ Time Frame: through the study completion, an average of 2 years ]

Central Contacts and Locations

Central contacts

Katherine Chin, DDS, MS

720-777-5320katherine.chin@childrenscolorado.org

Grace Diehl, DDS

720-777-6788grace.diehl@childrenscolorado.org

Locations

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Katherine Chin, DDS, MS

720-777-6788katherine.chin@childrenscolorado.org

Grace Diehl, DDS

720-777-6788grace.diehl@childrenscolorado.org

More Information

Sponsor

Children's Hospital Colorado

Last update posted

Sep 10, 2019

Last verified

Sep, 2019

Keywords

  • nitrous oxide
  • intranasal midazolam

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Colorado on 2019-09-10.