Gluing Lacerations Utilizing Epinephrine

Study Overview
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Brief Summary
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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.

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

Conditions
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Lacerations

Intervention / Treatment
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* Drug: LET - Lidocaine Epinephrine Tetracaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 0 to 17 years inclusive; with a laceration that is less than 3 cm in length (the upper limit recommended for tissue adhesive repair by the manufacturer). with said laceration on the face, torso, trunk or extremities; with said laceration deemed by the treating physician to be appropriate for repair via tissue adhesive Exclusion Criteria: the wound for study needs debridement or suturing prior to first glue attempt said wound is an animal or human bite or scratch wound, puncture wound, stellate crush wound, wound crossing mucocutaneous junctions, a scalp laceration, an ear laceration, a wound crossing a joint line, a wound on the fingers or toes, or a wound in an area of concentrated hair such as the eyebrow the patient has a history of keloid formation or a known allergy to cyanoacrylates or is presently taking oral steroids, immunostimulants, anticoagulants or other medications known to impair wound healing or haemostasis; or has a known diagnosis of Diabetes Mellitus or Vascular Insufficiency

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre-treatment with LET<br>Pre-treatment with Lidocaine Epinephrine Tetracaine solution at least 45 minutes prior to laceration repair with tissue adhesive | Drug: LET - Lidocaine Epinephrine Tetracaine<br>* One time application of 3 cc of Lidocaine Epinephrine Tetracaine Solution at least 45 minutes prior to laceration repair<br>* Other names: Lidocaine Adrenaline Tetracaine;|
| Placebo Comparator: Pre-treatment with Placebo<br>Pre-treatment with Placebo solution at least 45 minutes prior to laceration repair with tissue adhesive | Drug: LET - Lidocaine Epinephrine Tetracaine<br>* One time application of 3 cc of Lidocaine Epinephrine Tetracaine Solution at least 45 minutes prior to laceration repair<br>* Other names: Lidocaine Adrenaline Tetracaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain of Procedure Rating | 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). | 2 minutes post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Cosmesis | 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 | measured at 3 month f/u visit | 
| Ease of procedure as measured by treating physician | Immediately after the procedure, the treating physician will rate how easy the repair was on a 100 mm Visual Analog Scale. | 5 minutes post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LET, Histoacryl, Laceration, Lacerations, Lidocaine Epinephrine Tetracaine, LAT, Lidocaine Adrenaline Tetracaine, Tissue Adhesive, Skin Glue, Pre-Treatment with LET, Pre-Treatment with LAT, Pre-Treatment with Lidocaine Epinephrine Tetracaine, Pre-Treatment with Lidocaine Adrenaline Tetracaine, Use of LET with Skin Glue, Use of LET with Tissue Adhesive