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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-buffered Anesthetic | Drug | non-buffered LA, 2% lidocaine with epinephrine 1:100,000 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 10 minutes |
| Change in Heart Rate as Measured by as Measured by Medical Record | Baseline, Up to 10 minutes | |
| Change in Diastolic Blood Pressure as Measured by Medical Record | Baseline, Up to 10 minutes | |
| Change in Systolic Blood Pressure as Measured by Medical Record | Baseline, Up to 10 minutes | |
| Change in CO2 Level as Measured by Medical Record | Baseline, Up to 10 minutes | |
| Change in Oxygen Saturation Level as Measured by Medical Record | Baseline, Up to 10 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ying An, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dental Clinic of Rainbow Center for Women and Children | Cleveland | Ohio | 44103 | United States | ||
| Rainbow Babies and Children's Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | 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. Non-buffered Anesthetic: non-buffered LA, 2% lidocaine with epinephrine 1:100,000 Buffered Anesthetic: 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. Onset: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Buffered Anesthetic Side/Non-buffered Anesthetic Side | 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. Non-buffered Anesthetic: non-buffered LA, 2% lidocaine with epinephrine 1:100,000 Buffered Anesthetic: 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. Onset: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Up to 10 minutes |
|
Monitored during post op only, up to 3 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Buffered Anesthetic Side/Non-buffered Anesthetic Side | 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. Non-buffered Anesthetic: non-buffered LA, 2% lidocaine with epinephrine 1:100,000 Buffered Anesthetic: 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. Onset: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ying An | University Hospitals Cleveland Medical Center | (216)368-3277 | Ying.An@UHhospitals.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 16, 2019 | May 6, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014098 | Toothache |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D005157 | Facial Pain |
| D010146 | Pain |
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Patients serve as their own control. One side of the mouth is buffered, one side is non-buffered
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Participant and Care provider is blinded as to which side is buffered and which is non-buffered
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| Buffered Anesthetic | Drug | 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. |
|
| Onset | Device | 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. |
|
| Cleveland |
| Ohio |
| 44106 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Primary | Change in Heart Rate as Measured by as Measured by Medical Record | Posted | Mean | 95% Confidence Interval | Beats per minute | Baseline, Up to 10 minutes |
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| Primary | Change in Diastolic Blood Pressure as Measured by Medical Record | Posted | Mean | 95% Confidence Interval | mmHG | Baseline, Up to 10 minutes |
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| Primary | Change in Systolic Blood Pressure as Measured by Medical Record | Posted | Mean | 95% Confidence Interval | mmHG | Baseline, Up to 10 minutes |
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| Primary | Change in CO2 Level as Measured by Medical Record | Posted | Mean | 95% Confidence Interval | mEq/L | Baseline, Up to 10 minutes |
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| Primary | Change in Oxygen Saturation Level as Measured by Medical Record | Posted | Mean | 95% Confidence Interval | percentage of oxygen saturation | Baseline, Up to 10 minutes |
|
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Up to 10 mins Non-Buffered Side |
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| Up to 10 mins Non-Buffered Side |
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