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Comparison of Two Application Techniques for LET Gel

Primary Purpose

Lacerations, Pain, Procedural, LET

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Lacerations

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Children's Hospital of Orange County
Harbor-UCLA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Single LET

Triple LET

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Need for Additional Local Anesthetic

Need for additional infiltrated local anesthetic (lidocaine)

Full Information

NCT ID

NCT04203225

First Posted

December 16, 2019

Last Updated

January 30, 2021

Sponsor

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Collaborators

Children's Hospital of Orange County

1. Study Identification

Unique Protocol Identification Number

NCT04203225

Brief Title

Comparison of Two Application Techniques for LET Gel

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

May 22, 2017 (Actual)

Primary Completion Date

November 12, 2019 (Actual)

Study Completion Date

November 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Collaborators

Children's Hospital of Orange County

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lacerations, Pain, Procedural, LET

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

Care ProviderOutcomes Assessor

Masking Description

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)

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single LET

Arm Type

Active Comparator

Arm Description

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

Arm Title

Triple LET

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

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

Other Intervention Name(s)

LET

Intervention Description

Topical anesthetic

Primary Outcome Measure Information:

Title

Visual Analog Scale Pain Score

Description

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 Outcome Measure Information:

Title

Need for Additional Local Anesthetic

Description

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kelly D Young, MD

Organizational Affiliation

University of California, Los Angeles

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's Hospital of Orange County

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Harbor-UCLA Medical Center

City

Torrance

State/Province

California

ZIP/Postal Code

90502

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No plan

Citations:

PubMed Identifier

35100752

Citation

Siembieda J, Heyming T, Padlipsky P, Young KD. Triple Versus Single Application of Lidocaine, Epinephrine, and Tetracaine for Laceration Repair in Children. Pediatr Emerg Care. 2022 Feb 1;38(2):e472-e474. doi: 10.1097/PEC.0000000000002631.

Results Reference

derived

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Comparison of Two Application Techniques for LET Gel

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