Comparison of Two Application Techniques for LET Gel

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-22

Study Completion Date

2019-11-12

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.

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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.

Conditions

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Lacerations Pain, Procedural LET

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single-blinded randomized study; patients are randomized to one of two groups

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Investigator and nurse applied intervention and masked the intervention from the care provider. Separate nurse not caring for the patient, blinded to the intervention, brought in to obtain pain score (outcome)

Study Groups

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Single LET

One (single) application of LET topical gel \[Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%)\] applied for 30 minutes

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

Topical anesthetic

Triple LET

Three applications of LET topical gel, one applied every 10 minutes

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Topical anesthetic

Interventions

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

Topical anesthetic

Intervention Type DRUG

Other Intervention Names

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LET

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

Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No