Phase 4
N=48
Comparison of Two Application Techniques for LET Gel
Lacerations · Pain, Procedural · LET
Bottom Line
View on ClinicalTrials.gov: NCT04203225 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Visual Analog Scale Pain Score — 16; 16 mm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel (Drug)
- Age
- Pediatric · 7+ yrs
- Sex
- All
- Sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analog Scale Pain Score |
16; 16 | — |
| SECONDARY Need for Additional Local Anesthetic |
4; 5 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04203225). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.