Phase 4
Completed N=20
Buffered Local Anesthetic
Dental Pain
Source: ClinicalTrials.gov NCT05757648 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcomePrimary: Pain Score as Measured by the Behavior Pain Scale — 2.24; 2.61 score on a scale — p=0.005
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Score as Measured by the Behavior Pain Scale |
2.24; 2.61 | 0.005 sig |
| PRIMARY Change in Heart Rate as Measured by as Measured by Medical Record |
91; 95 | 0.775 |
| PRIMARY Change in Diastolic Blood Pressure as Measured by Medical Record |
52; 53.2 | 0.682 |
| PRIMARY Change in Systolic Blood Pressure as Measured by Medical Record |
91; 95 | — |
| PRIMARY Change in CO2 Level as Measured by Medical Record |
39.7; 40.3; 40.9; 40.2 | — |
| PRIMARY Change in Oxygen Saturation Level as Measured by Medical Record |
99.3; 99.0; 99.4; 99.2 | — |
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
Data sourced from ClinicalTrials.gov (NCT05757648). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.