Trial Outcomes & Findings for Efficacy of Buffered Lidocaine in Patients With Facial Swelling (NCT NCT01981772)

Results Overview

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."

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

88 participants

Primary outcome timeframe

during incision/drainage on Day 0

Results posted on

2020-10-12

Participant Flow

Participant milestones

Participant milestones
Measure	Buffered Lidocaine administration of 4% buffered lidocaine with 1:100,000 epinephrine 4% buffered lidocaine with 1:100,000 epinephrine	Nonbuffered Lidocaine administration of 4% lidocaine with 1:100,000 epinephrine 4% lidocaine with 1:100,000 epinephrine
Overall Study STARTED	45	43
Overall Study COMPLETED	45	43
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Buffered Lidocaine in Patients With Facial Swelling

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Buffered Lidocaine n=45 Participants administration of 4% buffered lidocaine with 1:100,000 epinephrine 4% buffered lidocaine with 1:100,000 epinephrine	Nonbuffered Lidocaine n=43 Participants administration of 4% lidocaine with 1:100,000 epinephrine 4% lidocaine with 1:100,000 epinephrine	Total n=88 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=5 Participants	43 Participants n=7 Participants	88 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	36.8 years STANDARD_DEVIATION 13.0 • n=5 Participants	36.3 years STANDARD_DEVIATION 13.4 • n=7 Participants	36.55 years STANDARD_DEVIATION 13.2 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	24 Participants n=7 Participants	50 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants	43 participants n=7 Participants	88 participants n=5 Participants

PRIMARY outcome

Timeframe: during incision/drainage on Day 0

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."

Outcome measures

Outcome measures
Measure	Buffered Lidocaine n=45 Participants administration of 4% buffered lidocaine with 1:100,000 epinephrine 4% buffered lidocaine with 1:100,000 epinephrine	Nonbuffered Lidocaine n=43 Participants administration of 4% lidocaine with 1:100,000 epinephrine 4% lidocaine with 1:100,000 epinephrine
Pain Measurement as Assessed on a Heft-Parker 170 mm Visual Analog Scale	69.3 units on a scale Standard Deviation 60.1	59.2 units on a scale Standard Deviation 50.5

SECONDARY outcome

Timeframe: immediately post-procedure on Day 0

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.

Outcome measures

Outcome measures
Measure	Buffered Lidocaine n=45 Participants administration of 4% buffered lidocaine with 1:100,000 epinephrine 4% buffered lidocaine with 1:100,000 epinephrine	Nonbuffered Lidocaine n=43 Participants administration of 4% lidocaine with 1:100,000 epinephrine 4% lidocaine with 1:100,000 epinephrine
Postoperative Satisfaction on a 100 mm Visual Analog Scale	92.7 units on a scale Standard Deviation 15.1	89.5 units on a scale Standard Deviation 13.7

Adverse Events

Buffered Lidocaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nonbuffered Lidocaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sara Fowler

The Ohio State University College of Dentistry

Phone: 6142923596

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place