N/A
N=88
Efficacy of Buffered Lidocaine in Patients With Facial Swelling
Orofacial Swelling
Bottom Line
View on ClinicalTrials.gov: NCT01981772 ↗Enrolled (actual)
88
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Pain Measurement as Assessed on a Heft-Parker 170 mm Visual Analog Scale — 69.3; 59.2 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 4% lidocaine with 1:100,000 epinephrine (Drug); 4% buffered lidocaine with 1:100,000 epinephrine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ohio State University
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Measurement as Assessed on a Heft-Parker 170 mm Visual Analog Scale |
69.3; 59.2 | — |
| SECONDARY Postoperative Satisfaction on a 100 mm Visual Analog Scale |
92.7; 89.5 | — |
Summary
The purpose of this study is to determine the clinical efficacy of a buffered 4% lidocaine solution for incision and drainage. Ninety patients will be examined clinically to determine a diagnosis of cellulitis or fluctuance. The diagnosis will be confirmed by incision and drainage. Patients will receive either 3.6 ml 4% lidocaine with 1:100,000 epinephrine or 3.6 ml 4% lidocaine with 1:100,000 epinephrine buffered with 8.4% sodium bicarbonate. Patients will rate pain prior to and throughout the procedure.
Eligibility Criteria
Inclusion Criteria
- 18 years or older
- in good health (ASA classification I or II)
- able to give informed consent
- necrotic tooth with associated facial swelling
Exclusion Criteria
- allergies to local anesthetics or sulfites
- history of significant medical problems (ASA classification III or greater)
- pregnancy
- inability to give informed consent
Data sourced from ClinicalTrials.gov (NCT01981772). 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.