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Comparison of 2 Application Techniques for LET Gel Used Prior to Simple Laceration Repair

NCT04536493 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2020-09-02

No results posted yet for this study

Summary

To compare pain scores during laceration repair with first suture placement using standardized visual analog scale (VAS) between 2 different topical local anesthetic application techniques for using LET gel. Specifically, the investigators are studying if applying LET gel 3 times, spaced 10 minutes apart (triple LET) provides superior anesthesia to one 30 minute application (single LET). Single LET is the current standard method of application.

Conditions

  • LET
  • Laceration of Skin

Interventions

DRUG

LET (lidocaine 4%; epinephrine 0.1%; tetracaine 0.5%) gel (1 application)

1 application of LET topical anesthetic gel

DRUG

LET (lidocaine 4%; epinephrine 0.1%; tetracaine 0.5%) gel (3 applications)

3 applications of LET topical anesthetic gel

Sponsors & Collaborators

  • Children's Hospital of Orange County

    lead OTHER

Principal Investigators

  • Joshua Siembieda · CHOC Childrens

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-19
Primary Completion
2019-11-06
Completion
2020-06-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04536493 on ClinicalTrials.gov