Comparison of 2 Application Techniques for LET Gel Used Prior to Simple Laceration Repair
Condition: LET; Laceration of Skin
MeSH terms: Lacerations
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): LET (lidocaine 4%; epinephrine 0.1%; tetracaine 0.5%) gel (1 application); LET (lidocaine 4%; epinephrine 0.1%; tetracaine 0.5%) gel (3 applications)
Intervention type(s): Drug; Drug
Intervention description(s): 1 application of LET topical anesthetic gel; 3 applications of LET topical anesthetic gel
Other intervention name(s): LET gel; LET gel
Intervention MeSH terms: Lidocaine; Epinephrine; Racepinephrine; Tetracaine; Epinephryl borate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial comparing two different applications of LET gel in pediatric patients with minor lacerations.
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment