Clinical Trial: Gluing Lacerations Utilizing Epinephrine

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Pretreatment of Lacerations With Topical LET (Lidocaine-Epinephrine-Tetracaine) Reduces Pain During Tissue Adhesive Repair in Children: Double-blind, Randomized, Controlle

Brief Summary: Minor lacerations are a commonly treated injury in the paediatric emergency department . Over the past decade, standard closure of these lacerations has evolved from suture repair to closure with tissue adhesive (also referred to as "skin glue"). Local anaesthetic is not routinely used during application of skin glue as it was with sutures. There are, however, several potential advantages to pre-treating wounds with topical LET (Lidocaine-Epinephrine-Tetracaine), a liquid gel with anaesthetic and vasoconstrictive properties. Some believe LET can improve patient comfort, increase the ease of glue application, and lead to better healing when used on lacerations being repaired with tissue adhesive. This study aims to address the question of whether or not pre-treatment with LET improves outcomes in minor lacerations repaired with skin glue. The primary hypothesis is that pre-treatment of minor lacerations with LET will decrease pain (as measured on a Visual Analog Scale) during repair with tissue adhesive.

Detailed Summary:
Sponsor: Children's Hospital of Eastern Ontario

Current Primary Outcome: Pain of Procedure Rating [ Time Frame: 2 minutes post-procedure ]

Patients will rate the pain experienced during their procedure on a 100 mm Visual Analog Scale (in paitents age 6 and under, parents will rate what pain they believe their child experienced).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Wound Cosmesis [ Time Frame: measured at 3 month f/u visit ]
    Patients will return 3 months post laceration repair for a photograph on their wound. Plastic surgeons blinded to the treatment arm will rate the wound cosmesis via the photographs on a validated 100 mm Visual Analog Scale
  • Ease of procedure as measured by treating physician [ Time Frame: 5 minutes post-procedure ]
    Immediately after the procedure, the treating physician will rate how easy the repair was on a 100 mm Visual Analog Scale.


Original Secondary Outcome: Same as current

Information By: Children's Hospital of Eastern Ontario

Dates:
Date Received: September 14, 2010
Date Started: April 2011
Date Completion:
Last Updated: April 9, 2013
Last Verified: April 2013