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

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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

Tracking Information
First Submitted Date  ICMJE August 16, 2019
First Posted Date  ICMJE September 10, 2019
Last Update Posted Date September 10, 2019
Actual Study Start Date  ICMJE July 12, 2019
Estimated Primary Completion Date July 11, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2019)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nitrous Oxide Prior to Intranasal Midazolam for Moderate Dental Sedation in Pediatric Patients
Official Title  ICMJE Effectiveness of Nitrous Oxide Administration Prior to Intranasal Midazolam for Moderate Sedation in Pediatric Dental Patients
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE
  • Dental Anxiety
  • Pain
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: 30% Nitrous Oxide with Midazolam
    30 percent nitrous oxide/70 percent oxygen will be administered for 5 minutes prior to intranasal midazolam.
    Interventions:
    • Drug: Nitrous Oxide
    • Drug: 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:
    • Drug: Nitrous Oxide
    • Drug: Midazolam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 5, 2019)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 11, 2021
Estimated Primary Completion Date July 11, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Katherine Chin, DDS, MS 720-777-5320 katherine.chin@childrenscolorado.org
Contact: Grace Diehl, DDS 720-777-6788 grace.diehl@childrenscolorado.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04083105
Other Study ID Numbers  ICMJE 19-0404
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is no plan to share individual personal data with other researchers.
Responsible Party Timothy Byrne, Children's Hospital Colorado
Study Sponsor  ICMJE Children's Hospital Colorado
Collaborators  ICMJE University of Colorado, Denver
Investigators  ICMJE
Principal Investigator: Katherine Chin, DDS, MS Children's Hospital Colorado
PRS Account Children's Hospital Colorado
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP