LacerationsPhase 4NCT04203225

Comparison of Two Application Techniques for LET Gel

A Phase 4 study testing LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel in people with Lacerations and Pain, Procedural, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 7 to 17 years
Conditions the study is for: Lacerations, Pain, Procedural, LET
What is being tested?: LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 2 sitesUnited States
Study dates: 22 May 2017to 12 Nov 2019
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 7 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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 locations and contacts

2 sites in 1 country.

United States2 sites

Children's Hospital of Orange County
Orange, California, 92868
Harbor-UCLA Medical Center
Torrance, California, 90502

Other trials in United States

About this study

Official 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

Read the 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
Being tested: LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel
Medical subject headings: Lacerations, Pain, Procedural

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gelDrug
Also called LET
Topical anesthetic

Study groups in NCT04203225
Study group	Role	What they receive
Single LET	Active comparator	One (single) application of LET topical gel [Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%)] applied for 30 minutes Receives: 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 Receives: Drug: LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: Immediately on placement or attempt at placement of first suture

Secondary outcomes (1)

Need for Additional Local Anesthetic
Need for additional infiltrated local anesthetic (lidocaine)
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 May 201712 Nov 2019

First posted18 Dec 2019
Study start22 May 2017
Primary completion12 Nov 2019
Study completion12 Nov 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for LacerationsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Single-blinded randomized study; patients are randomized to one of two groups
Masking: Double blind
Who is masked: Care provider, Outcomes assessor
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04203225
Sponsor's protocol ID: 30846-01
Status last verified: Jan 2021
First submitted: 16 Dec 2019
Last updated: 18 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: No plan

Publications

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.
PubMed 35100752

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT04203225
Acronym / sponsor ID: 30846-01
Conditions: Lacerations, Pain, Procedural, LET
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterUniversity, hospital or other
Collaborators: Children's Hospital of Orange County
Study start: 22 May 2017 (actual)
Primary completion: 12 Nov 2019 (actual)
Study completion: 12 Nov 2019 (actual)
First posted: 18 Dec 2019 (actual)
Results: Posted 18 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (care provider, outcomes assessor)
Number of arms: 2
Model description: Single-blinded randomized study; patients are randomized to one of two groups

Arm	Type	Receives
Single LET	Active comparator	Drug: LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gelOne (single) application of LET topical gel [Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%)] applied for 30 minutes
Triple LET	Experimental	Drug: LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gelThree applications of LET topical gel, one applied every 10 minutes

Who may qualify

Ages: 7 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gelAlso: LETTopical anesthetic	Drug	Single LET, Triple LET

Primary outcome

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)

1 secondary outcome

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.

Results and safety

Results posted to the registry on 18 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single LET	21	21
Triple LET	27	27

Primary outcome: Visual Analog Scale Pain Score

Time frame: Immediately on placement or attempt at placement of first suture. Mean (Standard Deviation). Unit: mm

Measure	Single LET n = 21	Triple LET n = 27
Value	16 (17)	16 (24)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: During the patient's emergency department visit until time of discharge.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single LET	0 of 21 (0%)	0 of 21 (0%)	0 of 21
Triple LET	0 of 27 (0%)	0 of 27 (0%)	0 of 27

Limitations and caveats (from the sponsor): * 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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35100752Siembieda 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.
Individual participant dataSharing planned: No. No plan

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kelly D Young, MD principal investigator

University of California, Los Angeles

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale Pain Score (time frame: Immediately on placement or attempt at placement of first suture). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04203225, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021; AzTrials last refreshed its copy on 26 Oct 2026.