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OpenTrials
Completed

NCT Number: NCT04203225

Comparison of Two Application Techniques for LET Gel

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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Key information

Conditions

Lacerations LET Neurologic Manifestations Pain Pain, Procedural Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Children's Hospital of Orange County, Orange, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Topical anesthetic

Other names: LET

Primary outcomes

  1. Visual Analog Scale Pain Score

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

    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 outcomes

  1. Need for Additional Local Anesthetic

    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.

    Need for additional infiltrated local anesthetic (lidocaine)

Sponsors and collaborators

Lead sponsor

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Other

Collaborators

  • Children's Hospital of Orange County

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 18, 2019
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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