Efficacy of Buffered Lidocaine in Patients With Facial Swelling

N/ACompletedNCT01981772

Ohio State University88 enrolled

Overview

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.

Incision and drainage of swellings is painful and anesthetic failure is common. One reason may be related to the lowered pH of inflamed tissue reducing the amount of the base form of anesthetic. A buffered anesthetic solution may result in more effective anesthesia than a non-buffered solution.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Orofacial Swelling

Interventions

4% lidocaine with 1:100,000 epinephrineDRUG

see arm/group description

4% buffered lidocaine with 1:100,000 epinephrineDRUG

see arm/group description

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

The Ohio State University College of Dentistry

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Pain Measurement as Assessed on a Heft-Parker 170 mm Visual Analog Scale

Patients will rate pain on a Heft-Parker visual analog scale during needle insertion, placement, and solution deposition phases of the anesthetic injection(s). Patients will also rate pain during the incision and dissection phases of the incision and drainage procedure. The number of millimeters along the scale are reported. No pain corresponded to 0 mm. Mild pain was defined as greater than 0 mm and less than or equal to 54 mm. Mild pain included the descriptors of "faint", "weak", and "mild pain". Moderate pain was defined as greater than 54 mm and less than 114 mm and included the descriptor "moderate". Severe pain was defined as equal to or greater than 114 mm up to and including 170 mm. Severe pain included the descriptors of "strong", "intense", and "maximum possible."

Time frame: during incision/drainage on Day 0

Secondary Outcomes

Postoperative Satisfaction on a 100 mm Visual Analog Scale

Patients will rate their level of satisfaction with the incision and drainage procedure using a visual analog scale. The scale ranges from "not satisfied," to "somewhat satisfied," to "moderately satisfied," to "completely satisfied." Not satisfied corresponded to 0 mm. Somewhat satisfied was defined as greater than 0 mm and less than or equal to 33 mm. Moderately satisfied was defined as greater than 33 mm and less than 66 mm. Completely satisfied was defined as equal to or greater than 66 mm. Measurements along the scale were collected and analyzed by randomization test.

Time frame: immediately post-procedure on Day 0

Data from ClinicalTrials.gov

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