NCT04536493

Comparison of 2 Application Techniques for LET Gel Used Prior to Simple Laceration Repair

Comparison of 2 Application Techniques for LET (Lidocaine 4%; Epinephrine 0.1%; Tetracaine 0.5%) Gel Used Prior to Simple Laceration Repair

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Children's Hospital of Orange County · Academic / Other
• Sex: All
• Age: 7 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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). Secondary endpoints: 1. To compare provider satisfaction scores using a Likert scale between the triple LET and single LET application techniques. 2. To compare parental satisfaction scores using a Likert scale between the triple LET and single LET application techniques. 3. To compare the need for additional local anesthetic infiltration between the triple LET and single LET application techniques. Once patients are identified and consent is obtained, they will be randomized to one of two groups. One group will have LET gel applied to the laceration one time for a duration of 30 minutes. The other group will have LET gel applied 3 times, at 10 minute intervals. Between applications, the excess gel on the surface of the skin will be gently wiped off, and a new strip of LET gel will be applied. The laceration repair will proceed in a normal sterile fashion, using standard irrigation and debridement techniques. Laceration repair will occur within the 15 minutes following the 30 minute period of LET application to the wound. The patient will be asked to rate his/her pain immediately after the first suture is placed or attempted using the visual analogue scale (VAS, range 0-10). The decision to use any additional anesthetic infiltration will be left to the performing provider. There will be 2 nurses involved in the study. One nurse will be the patient's primary nurse and will be administering the LET gel (so will not be blinded, but will not be involved in data collection). The other nurse will be obtaining the VAS immediately (Appendix 3) after the first suture is placed, using a pre-prepared script (Appendix 3) and standardized technique. The nurse or research assistant will also be blinded as to the method of LET gel application. The provider performing the laceration repair will be blinded. The research assistant will not be blinded and will coordinate all involved providers and nurses, will ensure correct timing in LET gel administration, and laceration repair timing.

Conditions

• LET
• Laceration of Skin

Interventions

Type	Name	Description
DRUG	LET (lidocaine 4%; epinephrine 0.1%; tetracaine 0.5%) gel (1 application)	1 application of LET topical anesthetic gel
DRUG	LET (lidocaine 4%; epinephrine 0.1%; tetracaine 0.5%) gel (3 applications)	3 applications of LET topical anesthetic gel

Timeline

• Start date: 2019-06-19
• Primary completion: 2019-11-06
• Completion: 2020-06-25
• First posted: 2020-09-02
• Last updated: 2020-09-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study