Buffered Local Anesthetic (NCT05757648) | Clinical Trial Compass
CompletedPhase 4
Buffered Local Anesthetic
United States20 participantsStarted 2020-12-08
Plain-language 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.
Who can participate
Age range
2 Years – 6 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain Score as Measured by the Behavior Pain Scale
Timeframe: Up to 10 minutes
2
Change in Heart Rate as Measured by as Measured by Medical Record
Timeframe: Baseline, Up to 10 minutes
3
Change in Diastolic Blood Pressure as Measured by Medical Record
Timeframe: Baseline, Up to 10 minutes
4
Change in Systolic Blood Pressure as Measured by Medical Record
Timeframe: Baseline, Up to 10 minutes
5
Change in CO2 Level as Measured by Medical Record
Timeframe: Baseline, Up to 10 minutes
6
Change in Oxygen Saturation Level as Measured by Medical Record
Timeframe: Baseline, Up to 10 minutes
Trial details
NCT IDNCT05757648
SponsorUniversity Hospitals Cleveland Medical Center