Trial Outcomes & Findings for Comparison of Two Application Techniques for LET Gel (NCT NCT04203225)

NCT ID: NCT04203225

Last Updated: 2021-02-18

Results Overview

Pain score self-rated by patient on 100m Visual Analog Pain scale, minimum value 0, maximum value 100, higher scores equal more pain (worse outcome)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 48 participants
• Primary outcome timeframe: Immediately on placement or attempt at placement of first suture
• Results posted on: 2021-02-18

Participant Flow

Convenience sample, pediatric emergency departments at Harbor-UCLA Medical Center and Children's Hospital of Orange County

Participant milestones

Measure	Single LET One (single) application of LET topical gel \[Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%)\] applied for 30 minutes LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel: Topical anesthetic	Triple LET Three applications of LET topical gel, one applied every 10 minutes LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel: Topical anesthetic
Overall Study STARTED	21	27
Overall Study COMPLETED	21	27
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Two Application Techniques for LET Gel

Baseline characteristics by cohort

Measure	Single LET n=21 Participants One (single) application of LET topical gel \[Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%)\] applied for 30 minutes LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel: Topical anesthetic	Triple LET n=27 Participants Three applications of LET topical gel, one applied every 10 minutes LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel: Topical anesthetic	Total n=48 Participants Total of all reporting groups
Age, Categorical <=18 years	21 Participants n=5 Participants	27 Participants n=7 Participants	48 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	10.7 years STANDARD_DEVIATION 3.1 • n=5 Participants	10.3 years STANDARD_DEVIATION 2.6 • n=7 Participants	10.5 years STANDARD_DEVIATION 2.8 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	23 Participants n=7 Participants	39 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic	14 Participants n=5 Participants	22 Participants n=7 Participants	36 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian / Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Other	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants	27 participants n=7 Participants	48 participants n=5 Participants
Laceration location Face/Scalp	18 Participants n=5 Participants	20 Participants n=7 Participants	38 Participants n=5 Participants
Laceration location Arm	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Laceration location Leg	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: Immediately on placement or attempt at placement of first suture

Pain score self-rated by patient on 100m Visual Analog Pain scale, minimum value 0, maximum value 100, higher scores equal more pain (worse outcome)

Outcome measures

Measure	Single LET n=21 Participants One (single) application of LET topical gel \[Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%)\] applied for 30 minutes LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel: Topical anesthetic	Triple LET n=27 Participants Three applications of LET topical gel, one applied every 10 minutes LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel: Topical anesthetic
Visual Analog Scale Pain Score	16 mm Standard Deviation 17	16 mm Standard Deviation 24

SECONDARY outcome

Timeframe: At any time during suturing procedure, time frame is duration of procedure, generally 10-20 minutes, less than one hour. Determined by chart review immediately after procedure completion.

Need for additional infiltrated local anesthetic (lidocaine)

Outcome measures

Measure	Single LET n=21 Participants One (single) application of LET topical gel \[Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%)\] applied for 30 minutes LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel: Topical anesthetic	Triple LET n=27 Participants Three applications of LET topical gel, one applied every 10 minutes LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel: Topical anesthetic
Need for Additional Local Anesthetic	4 Participants	5 Participants

Adverse Events

Single LET

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Triple LET

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

Kelly D. Young, MD

Harbor-UCLA Medical Center

Phone: 424-306-5431

Email: kyoung3@dhs.lacounty.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place