Dental PainPhase 4NCT05757648
Buffered Local Anesthetic
A Phase 4 study testing Non-buffered Anesthetic, Buffered Anesthetic and Onset in people with Dental Pain, run by University Hospitals Cleveland Medical Center at 2 sites in United States.
Trial summary
The purpose of this research study is to compare responses in children during dental injections of local anesthetic (used for numbing), while children are under deep sedation (breathing on their own, often with a loss of consciousness). Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Pain
- What is being tested?
- Non-buffered Anesthetic, Buffered Anesthetic and Onset
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Dec 2020to 12 Jun 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children or children with mild controlled systemic illness
- Treatment planned to receive restorative work on both sides of mouth (left vs right) under deep sedation, requiring local anesthetic administration
Who cannot join
- Children present with any illness or symptoms that can alter pain perception such as pain in head and neck area due to TMJ disorders, arthritis, autoimmune diseases
- Antibiotic premedication requirement
- History of taking medications (NSAIDs, narcotics, sedatives, and antianxiety or antidepressant medications) that may affect anesthetic assessment
- Has signs of dental pain, odontogenic abscess or facial cellulitis
- Allergy to local anesthetics or sulfites
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dental Clinic of Rainbow Center for Women and Children
Cleveland, Ohio, 44103
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
About this study
Official title: Effect of Buffered Anesthetic on Physiological Reactions During Dental Injection in Young Children Under Deep Sedation: A Prospective, Single Visit, Randomized, Double-Blind Split Mouth Study
The purpose of this research study is to compare responses in children during dental injections of local anesthetic (used for numbing), while children are under deep sedation (breathing on their own, often with a loss of consciousness). Two types of local anesthetic will be used--one will be buffered (by adding a salt solution to make it less acidic), while the other will be plain, without anything added. Previous studies have shown that the addition of the buffer solution can improve comfort during a dental injection.
- Conditions
- Dental Pain
- Being tested
- Non-buffered Anesthetic, Buffered Anesthetic, Onset
- Keywords
- Dental surgery, Deep sedation
- Medical subject headings
- Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-buffered AnestheticDrug
non-buffered LA, 2% lidocaine with epinephrine 1:100,000
Buffered AnestheticDrug
A cartridge of 2% lidocaine with epinephrine 1:100,000 alkalinized at 9:1 ratio with a resulting pH of 7.21 using 8.4% sodium bicarbonate solution per manufacturer.
OnsetDevice
The test solution will be made by a mixing pen called "Onset"- This mixing pen Onset will deliver 0.18 mL of sodium bicarbonate solution into the anesthetic cartridge.
| Study group | Role | What they receive |
|---|---|---|
| Buffered Anesthetic Side/Non-buffered Anesthetic Side | Experimental | Patients will be randomized to one side of the mouth getting the buffered anesthetic and the other side of the mouth to the non-buffered anesthetic.
Patients will be randomized to one side of the mouth getting the buffered anesthetic and the other side of the mouth to the non-buffered anesthetic. Receives: Drug: Non-buffered Anesthetic; Drug: Buffered Anesthetic; Device: Onset |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score as Measured by the Behavior Pain Scale
The BPS score ranges from 2 to 8 points. The higher the score, the more potential pain an unconscious patient is experiencing during sedation procedures.
Measured: Up to 10 minutes
Change in Heart Rate as Measured by as Measured by Medical Record
Measured: Baseline, Up to 10 minutes
Change in Diastolic Blood Pressure as Measured by Medical Record
Measured: Baseline, Up to 10 minutes
Change in Systolic Blood Pressure as Measured by Medical Record
Measured: Baseline, Up to 10 minutes
Change in CO2 Level as Measured by Medical Record
Measured: Baseline, Up to 10 minutes
Change in Oxygen Saturation Level as Measured by Medical Record
Measured: Baseline, Up to 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start8 Dec 2020
- Primary completion12 Jun 2023
- Study completion12 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dental PainStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Patients serve as their own control. One side of the mouth is buffered, one side is non-buffered
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying An, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757648
- Sponsor's protocol ID
- STUDY20191693
- Status last verified
- Jun 2024
- First submitted
- 23 Feb 2023
- Last updated
- 17 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Buffered Anesthetic on Physiological Reactions During Dental Injection in Young Children Under Deep Sedation: A Prospective, Single Visit, Randomized, Double-Blind Split Mouth Study
- ClinicalTrials.gov ID
- NCT05757648
- Acronym / sponsor ID
- STUDY20191693
- Conditions
- Dental Pain
- Keywords
- Dental surgery, Deep sedation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 12 Jun 2023 (actual)
- Study completion
- 12 Jun 2023 (actual)
- First posted
- 7 Mar 2023 (actual)
- Results
- Posted 17 Jul 2024
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 research study is to compare responses in children during dental injections of local anesthetic (used for numbing), while children are under deep sedation (breathing on their own, often with a loss of consciousness). Two types of local anesthetic will be used--one will be buffered (by adding a salt solution to make it less acidic), while the other will be plain, without anything added. Previous studies have shown that the addition of the buffer solution can improve comfort during a dental injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients serve as their own control. One side of the mouth is buffered, one side is non-buffered
| Arm | Type | Receives |
|---|---|---|
| Buffered Anesthetic Side/Non-buffered Anesthetic Side | Experimental | Drug: Non-buffered Anesthetic, Drug: Buffered Anesthetic, Device: OnsetPatients will be randomized to one side of the mouth getting the buffered anesthetic and the other side of the mouth to the non-buffered anesthetic. Patients will be randomized to one side of the mouth getting the buffered anesthetic and the other side of the mouth to the non-buffered anesthetic. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Healthy children or children with mild controlled systemic illness
- Treatment planned to receive restorative work on both sides of mouth (left vs right) under deep sedation, requiring local anesthetic administration
Key exclusion criteria (5 listed)
- Children present with any illness or symptoms that can alter pain perception such as pain in head and neck area due to TMJ disorders, arthritis, autoimmune diseases
- Antibiotic premedication requirement
- History of taking medications (NSAIDs, narcotics, sedatives, and antianxiety or antidepressant medications) that may affect anesthetic assessment
- Has signs of dental pain, odontogenic abscess or facial cellulitis
- Allergy to local anesthetics or sulfites
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 |
|---|---|---|
| Non-buffered Anestheticnon-buffered LA, 2% lidocaine with epinephrine 1:100,000 | Drug | Buffered Anesthetic Side/Non-buffered Anesthetic Side |
| Buffered AnestheticA cartridge of 2% lidocaine with epinephrine 1:100,000 alkalinized at 9:1 ratio with a resulting pH of 7.21 using 8.4% sodium bicarbonate solution per manufacturer. | Drug | Buffered Anesthetic Side/Non-buffered Anesthetic Side |
| OnsetThe test solution will be made by a mixing pen called "Onset"- This mixing pen Onset will deliver 0.18 mL of sodium bicarbonate solution into the anesthetic cartridge. | Device | Buffered Anesthetic Side/Non-buffered Anesthetic Side |
Primary outcome
Pain Score as Measured by the Behavior Pain Scale
Time frame: Up to 10 minutes
The BPS score ranges from 2 to 8 points. The higher the score, the more potential pain an unconscious patient is experiencing during sedation procedures.
Change in Heart Rate as Measured by as Measured by Medical Record
Time frame: Baseline, Up to 10 minutes
Change in Diastolic Blood Pressure as Measured by Medical Record
Time frame: Baseline, Up to 10 minutes
Change in Systolic Blood Pressure as Measured by Medical Record
Time frame: Baseline, Up to 10 minutes
Change in CO2 Level as Measured by Medical Record
Time frame: Baseline, Up to 10 minutes
Change in Oxygen Saturation Level as Measured by Medical Record
Time frame: Baseline, Up to 10 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Ying An, MD principal investigator
University Hospitals Cleveland Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Non-buffered Anesthetic, Buffered Anesthetic and Onset in people with Dental Pain, run by University Hospitals Cleveland Medical Center at 2 sites 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 17 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score as Measured by the Behavior Pain Scale (time frame: Up to 10 minutes). The study lists 6 primary outcomes in all. 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 17 Jul 2024.