Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04083105
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : September 10, 2019
Sponsor:
Collaborator:
University of Colorado, Denver
Information provided by (Responsible Party):
Timothy Byrne, Children's Hospital Colorado

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.

Condition or disease Intervention/treatment Phase
Dental Anxiety Pain Drug: Nitrous Oxide Drug: Midazolam Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants receiving moderate sedation for a dental procedure will be recruited and divided into one of two study arms.
Masking: Double (Participant, Care Provider)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Effectiveness of Nitrous Oxide Administration Prior to Intranasal Midazolam for Moderate Sedation in Pediatric Dental Patients
Actual Study Start Date : July 12, 2019
Estimated Primary Completion Date : July 11, 2021
Estimated Study Completion Date : July 11, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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 Name: N2O

Drug: Midazolam
Intranasal midazolam will be given after nitrous oxide administration.
Other Name: 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 Name: N2O

Drug: Midazolam
Intranasal midazolam will be given after nitrous oxide administration.
Other Name: Versed




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04083105


Contacts
Layout table for location contacts
Contact: Katherine Chin, DDS, MS 720-777-5320 katherine.chin@childrenscolorado.org
Contact: Grace Diehl, DDS 720-777-6788 grace.diehl@childrenscolorado.org

Locations
Layout table for location information
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Katherine Chin, DDS, MS    720-777-6788    katherine.chin@childrenscolorado.org   
Contact: Grace Diehl, DDS    720-777-6788    grace.diehl@childrenscolorado.org   
Sponsors and Collaborators
Children's Hospital Colorado
University of Colorado, Denver
Investigators
Layout table for investigator information
Principal Investigator: Katherine Chin, DDS, MS Children's Hospital Colorado
Layout table for additonal information
Responsible Party: Timothy Byrne, Regulatory Specialist, Children's Hospital Colorado
ClinicalTrials.gov Identifier: NCT04083105    
Other Study ID Numbers: 19-0404
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual personal data with other researchers.

Layout table for additional information
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
Keywords provided by Timothy Byrne, Children's Hospital Colorado:
nitrous oxide
intranasal midazolam
Additional relevant MeSH terms:
Layout table for MeSH terms
Midazolam
Nitrous Oxide
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Inhalation
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents