Comparison of Two Application Techniques for LET Gel (NCT04203225) | Clinical Trial Compass
CompletedPhase 4
Comparison of Two Application Techniques for LET Gel
United States48 participantsStarted 2017-05-22
Plain-language 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.
Who can participate
Age range
7 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared two ways of applying LET gel for numbing lacerations before repair — do you know which application technique was found to work better at reducing pain, and would that approach be used if my child or I needed a laceration repaired?
2Since this was a Phase 4 trial, meaning LET gel itself was already approved and in use, does that mean the safety of the gel is well-established, and the main question was just about how best to apply it?
3The trial measured pain using a Visual Analog Scale — can you explain what that means in practice, and how well LET gel typically controls pain during laceration repair compared to an injection like lidocaine?
4Are the results from this completed trial already influencing how your clinic applies LET gel, or is the standard approach here still the same as before?
5If LET gel doesn't provide enough numbing regardless of how it's applied, what would the next step be to manage pain during a laceration repair?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Visual Analog Scale Pain Score
Timeframe: Immediately on placement or attempt at placement of first suture
Trial details
NCT IDNCT04203225
SponsorLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center