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

September 5, 2019 updated by: Timothy Byrne, Children's Hospital Colorado

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study will determine the effectiveness of two different concentrations of nitrous oxide for reducing the pain of intranasal midazolam when given for subjects already planned for moderate sedation for completion of dental procedures in the pediatric dental clinic. Moderate dental sedation is useful because it helps relieve anxiety and make the dental procedure less memorable and more comfortable for the patient. Sedation appointments typically go smoothly when the patient is calm rather than when the patient is upset. Giving midazolam through the nose can be painful and the dental provider risks upsetting a patient and causing the sedation appointment to fail. Therefore, the goal of this study is to test whether nitrous oxide administration is effective in reducing the pain from intranasal midazolam administration. The effectiveness will be measured by the primary outcome of heart rate pre- and post- midazolam administration for the two randomly assigned study arms. The first study arm will be given 30% nitrous/70% oxygen and the second study arm will be given 70% nitrous/30% oxygen prior to the midazolam administration. The secondary outcome will compare subject, dental provider, and the parent/guardian answers to questions regarding the subject's experience pre- and post- midazolam administration. The investigators hypothesize lower changes in heart rate and less pain reported following midazolam administration in subjects given 70% nitrous oxide.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 30% Nitrous Oxide with Midazolam
30 percent nitrous oxide/70 percent oxygen will be administered for 5 minutes prior to intranasal midazolam.
Drug: 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.
Other Names:
  • N2O
Drug: Midazolam
Intranasal midazolam will be given after nitrous oxide administration.
Other Names:
  • Versed
Experimental: 70% Nitrous Oxide with Midazolam
70 percent nitrous oxide/30 percent oxygen will be administered for 5 minutes prior to intranasal midazolam.
Drug: 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.
Other Names:
  • N2O
Drug: Midazolam
Intranasal midazolam will be given after nitrous oxide administration.
Other Names:
  • Versed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate
Time Frame: through the study completion, an average of 2 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analog scales (VAS) for pain
Time Frame: through the study completion, an average of 2 years
Scale from 1 (no pain) to 10 (most possible pain). A higher score indicates greater pain. VAS will be obtained from the subjective standpoint of the parent/guardian of the parent and the dental provider during time points before and after the administration of intranasal midazolam.
through the study completion, an average of 2 years
Visual analog scales (VAS) for fear
Time Frame: through the study completion, an average of 2 years
Scale from 1 (no fear) to 10 (very fearful). A higher score indicates greater fear. VAS will be obtained from the subjective standpoint of the parent/guardian of the parent and the dental provider during time points before and after the administration of intranasal midazolam.
through the study completion, an average of 2 years
Wong-Baker Faces scale for pain
Time Frame: through the study completion, an average of 2 years
Scale from 0 (no hurt) to 10 (hurts worst). A higher score indicates more pain. Wong-Baker Faces scale will be recorded from the subjective standpoint of the participant.
through the study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Colorado

Collaborators

University of Colorado, Denver

Investigators

  • Principal Investigator: Katherine Chin, DDS, MS, Children's Hospital Colorado

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2019

Primary Completion (Anticipated)

July 11, 2021

Study Completion (Anticipated)

July 11, 2021

Study Registration Dates

First Submitted

August 16, 2019

First Submitted That Met QC Criteria

September 5, 2019

First Posted (Actual)

September 10, 2019

Study Record Updates

Last Update Posted (Actual)

September 10, 2019

Last Update Submitted That Met QC Criteria

September 5, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-0404

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is no plan to share individual personal data with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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