Phase 4
N=20
Comparison of Pain of Conventional to Buffered Local Anesthesia During Injection in Pediatric Dental Patients
Pain
Bottom Line
View on ClinicalTrials.gov: NCT01622296 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Participant Pain Experience After Administration of Local Anesthesia to Numb the Gums and Teeth During Dental Treatment — 43; 33.1; 7.3; 9.8 units on a scale — p=0.23
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sodium bicarbonate (Drug); Lidocaine (Drug)
- Age
- Pediatric · 9+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participant Pain Experience After Administration of Local Anesthesia to Numb the Gums and Teeth During Dental Treatment |
43; 33.1; 7.3; 9.8 | 0.23 |
Summary
The purpose of this study is to determine the effectiveness of buffered local anesthesia injections to numb the gums and teeth during dental treatment. Adjusting the pH of lidocaine with sodium bicarbonate may reduce the pain of injection for both adults and children. In this study, the investigators will compare two local anesthetic preparations, a buffered anesthetic and the conventionally available anesthetic, for pain upon injection.
Hypothesis: Anesthetic buffered to physiologic pH will result in a less painful injection compared to the acidic alternative used in most dental offices. This can be demonstrated by comparing two local anesthetic preparations, a buffered anesthetic and the conventionally available anesthetic, for pain upon injection.
Eligibility Criteria
Inclusion Criteria
- Give written, informed consent (both the subject and the legal guardian)
- Be 9-12 years of age
- Be able to comprehend the visual analog scale (instructions given to ascertain this)
- Be able to comprehend the verbal rating scale (instructions given to ascertain this)
- In the opinion of the investigator, be a subject who can be expected to comply with the protocol
- Present moderate mandibular dental disease bilaterally
- Have 4 to 7 natural teeth (with at least one posterior tooth) present in each mandibular quadrant with moderate dental disease on at least one tooth
- Be willing to attend the clinic for 3 or more appointments
Exclusion Criteria
- Antibiotic premedication requirement
- A history of allergy, sensitivity, or any other form of adverse reactions to local anesthetics of the amide type, or epinephrine
- A history of specific systemic illness that would preclude administration of a local anesthetic or vasoconstrictor (epinephrine) (e.g. liver , renal, cardiovascular diseases, blood dyscrasias, psychiatric disorders, etc.)
- A history of systemic illness that would interfere with healing response (e.g. liver disease, blood dyscrasias, uncontrolled diabetes, etc.)
- Current systemic medication that interferes with healing response
- Current systemic medication which contraindicates the use of local anesthetics or epinephrine
- Pregnant or lactating females (contradicts the use of local anesthetic in non-emergency type dental procedures)
- Current alcohol or drug abuse
- Received an anesthetic, analgesic or sedative within 24 hours prior to the therapy appointments
- Acute infections or conditions in the oral cavity requiring immediate treatment
- Participation in a clinical study of an investigational drug within the previous 4 weeks
- Previous enrollment in the present study
Data sourced from ClinicalTrials.gov (NCT01622296). 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.