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

NCT ID: NCT04536493

Last Updated: 2020-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-19
• Study Completion Date: 2020-06-25

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1 application

Patients receive single dose LET

Group Type: ACTIVE_COMPARATOR

LET (lidocaine 4%; epinephrine 0.1%; tetracaine 0.5%) gel (1 application)

Intervention Type: DRUG

1 application of LET topical anesthetic gel

3 applications

Patients receive 3 doses of LET

Group Type: ACTIVE_COMPARATOR

LET (lidocaine 4%; epinephrine 0.1%; tetracaine 0.5%) gel (3 applications)

Intervention Type: DRUG

3 applications of LET topical anesthetic gel

Interventions

LET (lidocaine 4%; epinephrine 0.1%; tetracaine 0.5%) gel (1 application)

1 application of LET topical anesthetic gel

Intervention Type: DRUG

LET (lidocaine 4%; epinephrine 0.1%; tetracaine 0.5%) gel (3 applications)

3 applications of LET topical anesthetic gel

Intervention Type: DRUG

Other Intervention Names

LET gel; LET gel

Eligibility Criteria

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Orange County

OTHER

Sponsor Role: lead

Responsible Party

Theodore Heyming

Physician; Emergency Department Medical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joshua Siembieda

Role: PRINCIPAL_INVESTIGATOR

CHOC Childrens

Locations

CHOC Children's

Orange, California, United States

Countries

United States

References

Harman S, Zemek R, Duncan MJ, Ying Y, Petrcich W. Efficacy of pain control with topical lidocaine-epinephrine-tetracaine during laceration repair with tissue adhesive in children: a randomized controlled trial. CMAJ. 2013 Sep 17;185(13):E629-34. doi: 10.1503/cmaj.130269. Epub 2013 Jul 29.

Reference Type: BACKGROUND

PMID: 23897942 (View on PubMed)

Priestley S, Kelly AM, Chow L, Powell C, Williams A. Application of topical local anesthetic at triage reduces treatment time for children with lacerations: a randomized controlled trial. Ann Emerg Med. 2003 Jul;42(1):34-40. doi: 10.1067/mem.2003.207.

Reference Type: BACKGROUND

PMID: 12827121 (View on PubMed)

Other Identifiers

190224

Identifier Type: -

Identifier Source: org_study_id