Comparison of Two Application Techniques for LET Gel

Pain, Procedural Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04203225
• Other study ID #: 30846-01
• Status: Completed
• Phase: Phase 4
• Start date: May 22, 2017
• Est. completion date: November 12, 2019

Study information

• Verified date: January 2021
• Source: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 12, 2019
• Est. primary completion date: November 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Lacerations
• LET
• Pain, Procedural

Intervention

Drug:
• LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel
Topical anesthetic

Locations

Country	Name	City	State
United States	Children's Hospital of Orange County	Orange	California
United States	Harbor-UCLA Medical Center	Torrance	California

Sponsors (2)

Lead Sponsor	Collaborator
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	Children's Hospital of Orange County

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.