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Comparison of Two Application Techniques for LET Gel

L

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Status and phase

Completed
Phase 4

Conditions

Lacerations
LET
Pain, Procedural

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04203225
30846-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 patients

Sex

All

Ages

7 to 17 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

48 participants in 2 patient groups

Single LET
Active Comparator group
Description:
One (single) application of LET topical gel \[Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%)\] applied for 30 minutes
Treatment:
Drug: LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel
Triple LET
Experimental group
Description:
Three applications of LET topical gel, one applied every 10 minutes
Treatment:
Drug: LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel

Trial documents
1

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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