Comparison of Two Application Techniques for LET Gel

NCT04203225 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 30846-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Lacerations; Pain, Procedural; LET

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Need for Additional Local Anesthetic

  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.

Study Arms (2)

Single LET

ACTIVE COMPARATOR

One (single) application of LET topical gel \[Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%)\] applied for 30 minutes

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

Triple LET

EXPERIMENTAL

Three applications of LET topical gel, one applied every 10 minutes

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

Interventions

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

Topical anesthetic

Also known as: LET

Single LET; Triple LET

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Simple \<= 3cm lacerations requiring suturing (as decided by clinician care providers)
• Plan to suture with simple interrupted sutures

You may not qualify if:

• 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

Sponsors & Collaborators

• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: lead
• Children's Hospital of Orange County: collaborator

Study Sites (2)

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

Related Publications (1)

• Siembieda J, Heyming T, Padlipsky P, Young KD. Triple Versus Single Application of Lidocaine, Epinephrine, and Tetracaine for Laceration Repair in Children. Pediatr Emerg Care. 2022 Feb 1;38(2):e472-e474. doi: 10.1097/PEC.0000000000002631.

  PMID: 35100752 DERIVED

MeSH Terms

Conditions

Lacerations; Pain, Procedural

Interventions

Epinephrine; Tetracaine; Gels; Linear Energy Transfer

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Energy Transfer; Biophysical Phenomena; Physical Phenomena; Biochemical Phenomena; Chemical Phenomena

Limitations and Caveats

* Unable to blind the patient and nurse caring for the patient * Wide age range from which we recruited patients * We included children only age 7 years and older in order to be able to obtain a self-reported VAS pain score * Majority of lacerations were on the face / scalp * Sustaining a laceration and then being in an emergency department is already traumatic for young children; could interfere with pain scores

Results Point of Contact

• Title: Kelly D. Young, MD
• Organization: Harbor-UCLA Medical Center

kyoung3@dhs.lacounty.gov

424-306-5431

Study Officials

• Kelly D Young, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Investigator and nurse applied intervention and masked the intervention from the care provider. Separate nurse not caring for the patient, blinded to the intervention, brought in to obtain pain score (outcome)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physician

Model Details: Single-blinded randomized study; patients are randomized to one of two groups

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: December 18, 2019
• Study Start: May 22, 2017
• Primary Completion: November 12, 2019
• Study Completion: November 12, 2019
• Last Updated: February 18, 2021
• Results First Posted: February 18, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)