Comparison of Two Application Techniques for LET Gel

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of 2 Application Techniques for LET (Lidocaine 4%; Epinephrine 0.1%; Tetracaine 0.5%) Gel Used Prior to Simple Laceration Repair in Children

Conditions
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Lacerations, Pain, Procedural, LET

Intervention / Treatment
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* Drug: LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-blinded randomized study; patients are randomized to one of two groups
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single LET<br>One (single) application of LET topical gel [Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%)] applied for 30 minutes | Drug: LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel<br>* Topical anesthetic<br>* Other names: LET;|
| Experimental: Triple LET<br>Three applications of LET topical gel, one applied every 10 minutes | Drug: LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel<br>* Topical anesthetic<br>* Other names: LET;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale Pain Score | 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) | Immediately on placement or attempt at placement of first suture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for Additional Local Anesthetic | Need for additional infiltrated local anesthetic (lidocaine) | 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. |