Comparison of 2 Application Techniques for LET Gel Used Prior to Simple Laceration Repair (NCT04536493) | Clinical Trial Compass
CompletedPhase 4
Comparison of 2 Application Techniques for LET Gel Used Prior to Simple Laceration Repair
United States48 participantsStarted 2019-06-19
Plain-language 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.
Who can participate
Age range
7 Years – 18 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:
* • Patients with simple (\< 3 cm) lacerations who are \> 7 years old and \< 18 years old, for whom the physician plans to close the laceration using simple superficial interrupted sutures.
Exclusion Criteria:
* • Lacerations involving the hands, feet, genitals, tongue, mucus membranes, nose, ears, or occurring over joints.
* Patients who are developmentally delayed or have a disability preventing them from giving a reliable pain score.
* Patients whose primary language is other than English or Spanish.
* Patients for whom procedural sedation is required.
* Patients receiving intranasal or oral midazolam or inhaled nitrous oxide.
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 before stitching a skin cut — can you explain what those two techniques are and whether one of them is already being used here to numb the area before my laceration is repaired?
2Since this was a Phase 4 trial that's already completed, does that mean there are results available showing which application method worked better for reducing pain, and how might those results change how my wound is treated today?
3LET gel is a topical numbing agent — how effective is it on its own for a laceration like mine, and are there cases where additional local anesthetic injections would still be needed on top of it?
4Are there any differences in how well LET gel works depending on where on the body the cut is, or how deep or long the laceration is, that I should know about before my repair?
5If the technique used to apply LET gel can affect how much pain I feel during the repair, is it worth asking specifically which method the care team plans to use and whether it reflects the findings from this study?
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
To compare pain scores
Timeframe: The VAS to rate pain will be collected during laceration repair, immediately after the first suture placement or attempt. The VAS score is estimated to take up to 1 minute to collect. The VAS scale will be collected for each enrolled subject.