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

NCT04083105 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: 19-0404
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

nitrous oxide; intranasal midazolam

Outcome Measures

Primary Outcomes (1)

• Heart rate

  Measured in beats per minute with range from 50-190 bpm. A great change in heart rate indicates more pain and less effect of the nitrous oxide. Heart rate is an autonomic reflex to determine the effect of mental and physical stressors including painful stimuli. The participants resting heart rate will be compared to the heart rate immediately after intranasal midazolam administration for a change in heart rate value.

  through the study completion, an average of 2 years

Secondary Outcomes (3)

• Visual analog scales (VAS) for pain

  through the study completion, an average of 2 years

• Visual analog scales (VAS) for fear

  through the study completion, an average of 2 years

• Wong-Baker Faces scale for pain

  through the study completion, an average of 2 years

Study Arms (2)

30% Nitrous Oxide with Midazolam

EXPERIMENTAL

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

Drug: Nitrous Oxide; Drug: Midazolam

70% Nitrous Oxide with Midazolam

EXPERIMENTAL

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

Drug: Nitrous Oxide; Drug: Midazolam

Interventions

Nitrous Oxide DRUG

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.

Also known as: N2O

30% Nitrous Oxide with Midazolam; 70% Nitrous Oxide with Midazolam

Midazolam DRUG

Intranasal midazolam will be given after nitrous oxide administration.

Also known as: Versed

30% Nitrous Oxide with Midazolam; 70% Nitrous Oxide with Midazolam

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Children's Hospital Colorado: lead
• University of Colorado, Denver: collaborator

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Nitrous Oxide; Midazolam

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Katherine Chin, DDS, MS

  Children's Hospital Colorado

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine Chin, DDS, MS

CONTACT

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

Grace Diehl, DDS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Sedation provider who will administer the pain scale tests and the participant will be masked to the subject's assigned study arm (30% or 70% nitrous oxide with midazolam). The attending pediatric dentist and dental assistant will not be blinded for patient safety.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Regulatory Specialist

Model Details: Participants receiving moderate sedation for a dental procedure will be recruited and divided into one of two study arms.

Study Record Dates

• First Submitted: August 16, 2019
• First Posted: September 10, 2019
• Study Start: July 12, 2019
• Primary Completion: July 11, 2021
• Study Completion: July 11, 2021
• Last Updated: September 10, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)