Comparison of Two Application Techniques for LET Gel

Phase 4

Completed

• Conditions: Lacerations; LET; Pain, Procedural
• Interventions: Drug: LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel

• Registration Number: NCT04203225
• Lead Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Brief Summary

Comparison of anesthetic efficacy of Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel (LET) applied three times for 10 minutes each time vs. once for 30 minutes prior to suturing simple lacerations in children aged 7-17 years.

Detailed Description

Randomized single-blinded clinical trial with convenience sampling of the anesthetic efficacy of a single 30-minute application vs three 10-minute applications of Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel (LET) prior to suturing simple lacerations in children aged 7-17 years seen in the Emergency Department.

Study Timeline

• Study Start: 2017-05-22
• Primary Completion: 2019-11-12
• Study Completion: 2019-11-12
• Study First Submitted: 2019-12-16
• Study First Submitted QC: 2019-12-16
• Study First Posted: 2019-12-18
• Status Verified: 2021-01
• Results First Submitted: 2021-01-30
• Results First Submitted QC: 2021-01-30
• Last Update Submitted: 2021-01-30
• Results First Posted: 2021-02-18
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Simple <= 3cm lacerations requiring suturing (as decided by clinician care providers)
• Plan to suture with simple interrupted sutures

Exclusion Criteria

• Lacerations involving the hands, feet, genitals, tongue, mucus membranes, nose, ears, or occurring over joints
• Patients whose primary language was neither English nor Spanish
• Developmentally delayed or disabled patient such that they were unable to give a pain score
• Patients requiring procedural sedation or anxiolysis with oral or intranasal midazolam

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single LET	LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel	One (single) application of LET topical gel \[Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%)\] applied for 30 minutes
Triple LET	LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel	Three applications of LET topical gel, one applied every 10 minutes

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale Pain Score	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)

Secondary Outcome Measures

Name	Time	Method
Need for Additional Local Anesthetic	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)

Trial Locations

Locations (2)

Children's Hospital of Orange County; 🇺🇸 Orange, California, United States

Harbor-UCLA Medical Center; 🇺🇸 Torrance, California, United States