Back to resultsBuffered Local Anesthetic
Primary Purpose
Dental Pain
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Non-buffered Anesthetic
Buffered Anesthetic
Onset
Sponsored by
About this trial
This is an interventional treatment trial for Dental Pain focused on measuring Dental surgery, Deep sedation
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- Dental Clinic of Rainbow Center for Women and Children
- Rainbow Babies and Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Buffered Anesthetic
Non-buffered Anesthetic
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Change in heart rate as measured by as measured by medical record
Change in blood pressure as measured by medical record
Change in CO2 level as measured by medical record
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05757648
Brief Title
Buffered Local Anesthetic
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 8, 2020 (Actual)
Primary Completion Date
June 12, 2023 (Actual)
Study Completion Date
June 12, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ying An, MD
4. Oversight
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.
No
Data Monitoring Committee
No
5. Study Description
Brief 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). 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Pain
Keywords
Dental surgery, Deep sedation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Buffered Anesthetic
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-buffered Anesthetic
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Non-buffered Anesthetic
Intervention Description
non-buffered LA, 2% lidocaine with epinephrine 1:100,000
Intervention Type
Drug
Intervention Name(s)
Buffered Anesthetic
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Onset
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain score as measured by the behavior pain scale
Description
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.
Time Frame
Up to 10 minutes
Title
Change in heart rate as measured by as measured by medical record
Time Frame
Baseline, Up to 10 minutes
Title
Change in blood pressure as measured by medical record
Time Frame
Baseline, Up to 10 minutes
Title
Change in CO2 level as measured by medical record
Time Frame
Baseline, Up to 10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying An, MD
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dental Clinic of Rainbow Center for Women and Children
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44103
Country
United States
Facility Name
Rainbow Babies and Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Buffered Local Anesthetic
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