NCT04203225

Comparison of Two Application Techniques for LET Gel

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center · Academic / Other
• Sex: All
• Age: 7 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lacerations
• Pain, Procedural
• LET

Interventions

Type	Name	Description
DRUG	LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel	Topical anesthetic

Timeline

• Start date: 2017-05-22
• Primary completion: 2019-11-12
• Completion: 2019-11-12
• First posted: 2019-12-18
• Last updated: 2021-02-18
• Results posted: 2021-02-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study