Dental AnxietyPhase 4NCT04083105
Nitrous Oxide Prior to Intranasal Midazolam for Moderate Dental Sedation in Pediatric Patients
A Phase 4 study testing Nitrous Oxide and Midazolam in people with Dental Anxiety and Pain, run by Children's Hospital Colorado at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Dental Anxiety, Pain
- What is being tested?
- Nitrous Oxide and Midazolam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2019to 11 Jul 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
Katherine Chin, DDS, MS, 720-777-6788, katherine.chin@childrenscolorado.org
Grace Diehl, DDS, 720-777-6788, grace.diehl@childrenscolorado.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Dental Anxiety, Pain
- Being tested
- Nitrous Oxide, Midazolam
- Keywords
- nitrous oxide, intranasal midazolam
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrous OxideDrug
Also called N2O
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.
MidazolamDrug
Also called Versed
Intranasal midazolam will be given after nitrous oxide administration.
| Study group | Role | What they receive |
|---|---|---|
| 30% Nitrous Oxide with Midazolam | Experimental | 30 percent nitrous oxide/70 percent oxygen will be administered for 5 minutes prior to intranasal midazolam. Receives: 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. Receives: Drug: Nitrous Oxide; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through the study completion, an average of 2 years
Secondary outcomes (3)
Visual analog scales (VAS) for pain
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.
Measured: through the study completion, an average of 2 years
Visual analog scales (VAS) for fear
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.
Measured: through the study completion, an average of 2 years
Wong-Baker Faces scale for pain
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.
Measured: through the study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start12 Jul 2019
- Primary completion11 Jul 2021 (estimated)
- Study completion11 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants receiving moderate sedation for a dental procedure will be recruited and divided into one of two study arms.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Colorado
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver
- Responsible party
- Principal investigator, Timothy Byrne, Children's Hospital Colorado
- Investigators
- Katherine Chin, DDS, MS, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04083105
- Sponsor's protocol ID
- 19-0404
- Status last verified
- Sep 2019
- First submitted
- 16 Aug 2019
- Last updated
- 10 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual personal data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Nitrous Oxide Administration Prior to Intranasal Midazolam for Moderate Sedation in Pediatric Dental Patients
- ClinicalTrials.gov ID
- NCT04083105
- Acronym / sponsor ID
- 19-0404
- Conditions
- Dental Anxiety, Pain
- Keywords
- nitrous oxide, intranasal midazolam
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Children's Hospital ColoradoUniversity, hospital or other
- Collaborators
- University of Colorado, Denver
- Study start
- 12 Jul 2019 (actual)
- Primary completion
- 11 Jul 2021 (estimated)
- Study completion
- 11 Jul 2021 (estimated)
- First posted
- 10 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Participants receiving moderate sedation for a dental procedure will be recruited and divided into one of two study arms.
| Arm | Type | Receives |
|---|---|---|
| 30% Nitrous Oxide with Midazolam | Experimental | Drug: Nitrous Oxide, Drug: Midazolam30 percent nitrous oxide/70 percent oxygen will be administered for 5 minutes prior to intranasal midazolam. |
| 70% Nitrous Oxide with Midazolam | Experimental | Drug: Nitrous Oxide, Drug: Midazolam70 percent nitrous oxide/30 percent oxygen will be administered for 5 minutes prior to intranasal midazolam. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitrous OxideAlso: N2ONitrous 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. | Drug | 30% Nitrous Oxide with Midazolam, 70% Nitrous Oxide with Midazolam |
| MidazolamAlso: VersedIntranasal midazolam will be given after nitrous oxide administration. | Drug | 30% Nitrous Oxide with Midazolam, 70% Nitrous Oxide with Midazolam |
Primary outcome
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.
3 secondary outcomes
Visual analog scales (VAS) for pain
Time frame: 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
Wong-Baker Faces scale for pain
Time frame: through the study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
- Individual participant dataSharing planned: No. There is no plan to share individual personal data with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Chin, DDS, MS principal investigator
Children's Hospital Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nitrous Oxide and Midazolam in people with Dental Anxiety and Pain, run by Children's Hospital Colorado at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katherine Chin, DDS, MS (720-777-5320, katherine.chin@childrenscolorado.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (time frame: through the study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2019.