Comparison of Two Application Techniques for LET Gel

Phase 4CompletedNCT04203225

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center48 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Lacerations Pain, Procedural LET

Interventions

LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gelDRUG

Topical anesthetic

Eligibility

Sex: ALLMin age: 7 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (2)

Children's Hospital of Orange County

Orange, California, United States

Harbor-UCLA Medical Center

Torrance, California, United States

Outcomes

Primary Outcomes

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)

Time frame: Immediately on placement or attempt at placement of first suture

Secondary Outcomes

Need for Additional Local Anesthetic

Need for additional infiltrated local anesthetic (lidocaine)

Time frame: 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.

Data from ClinicalTrials.gov

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