Clinical trial NCT04536493: Comparison of 2 Application Techniques for LET Gel Used Prior to Simple Laceration Repair
Official title: Comparison of 2 Application Techniques for LET (Lidocaine 4%; Epinephrine 0.1%; Tetracaine 0.5%) Gel Used Prior to Simple Laceration Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: LET
Laceration of Skin
Lead sponsor: Children's Hospital of Orange County
Sponsor class: OTHER
First posted: 2020-09-02
Enrollment: 48
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial comparing two different applications of LET gel in pediatric patients with minor lacerations.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: To compare provider satisfaction scores
timeFrame: The provider satisfaction Likert scale will be collected immediately after the procedure.
measure: To compare parental satisfaction scores
timeFrame: The parental satisfaction Likert scale will be collected immediately after the procedure.
Other outcomes:
Locations:
city: Orange
country: United States
facility: CHOC Children's
state: California
Study officials:
affiliation: CHOC Childrens
name: Joshua Siembieda
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.