Clinical trial NCT01202487: Gluing Lacerations Utilizing Epinephrine
Official title: Pretreatment of Lacerations With Topical LET (Lidocaine-Epinephrine-Tetracaine) Reduces Pain During Tissue Adhesive Repair in Children: Double-blind, Randomized, Controlled Trial of Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lacerations
Keywords: Laceration
Lacerations
LET
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
Histoacryl
Lead sponsor: Children's Hospital of Eastern Ontario
Sponsor class: OTHER
First posted: 2010-09-16
Enrollment: 222
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain of Procedure Rating
timeFrame: 2 minutes post-procedure
Secondary outcomes:
measure: Wound Cosmesis
timeFrame: measured at 3 month f/u visit
measure: Ease of procedure as measured by treating physician
timeFrame: 5 minutes post-procedure
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
Study officials:
affiliation: Children's Hospital of Eastern Ontario
name: Stuart GS Harman, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Eastern Ontario
name: Roger Zemek, MD FRCPC
role: STUDY_DIRECTOR
References: