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

NCT04536493 | Completed Phase 4 FDA Drug

• 1 other identifier: 190224
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

LET; Laceration of Skin

Outcome Measures

Primary Outcomes (1)

• To compare pain scores

  Visual Analog Scale (VAS) asks subjects to rate pain marking an X on a line between two ends: "No pain" (on the left) and "Pain as bad as it could possibly be" (on the right). The distance will be measured from "No pain" to the X placed by the subject. A higher measurement indicates more pain.

  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.

Secondary Outcomes (2)

• To compare provider satisfaction scores

  The provider satisfaction Likert scale will be collected immediately after the procedure.

• To compare parental satisfaction scores

  The parental satisfaction Likert scale will be collected immediately after the procedure.

Study Arms (2)

1 application

ACTIVE COMPARATOR

Patients receive single dose LET

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

3 applications

ACTIVE COMPARATOR

Patients receive 3 doses of LET

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

Interventions

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

1 application of LET topical anesthetic gel

Also known as: LET gel

1 application

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

3 applications of LET topical anesthetic gel

Also known as: LET gel

3 applications

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Orange County: lead

Study Sites (1)

CHOC Children's

Orange, California, 92868, United States

Location

Related Publications (2)

• 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.

  PMID: 23897942 BACKGROUND

• 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.

  PMID: 12827121 BACKGROUND

MeSH Terms

Interventions

Linear Energy Transfer; Tetracaine; Gels

Intervention Hierarchy (Ancestors)

Energy Transfer; Biophysical Phenomena; Physical Phenomena; Biochemical Phenomena; Chemical Phenomena; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Joshua Siembieda

  CHOC Childrens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Topical anesthetic applied by RN not involved in procedure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician; Emergency Department Medical Director

Model Details: Randomized controlled trial comparing two different applications of LET gel in pediatric patients with minor lacerations.

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: September 2, 2020
• Study Start: June 19, 2019
• Primary Completion: November 6, 2019
• Study Completion: June 25, 2020
• Last Updated: September 2, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)