Gluing Lacerations Utilizing Epinephrine
Information source: Children's Hospital of Eastern Ontario
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lacerations
Intervention: LET - Lidocaine Epinephrine Tetracaine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Children's Hospital of Eastern Ontario Official(s) and/or principal investigator(s): Stuart GS Harman, MD FRCPC, Principal Investigator, Affiliation: Children's Hospital of Eastern Ontario Roger Zemek, MD FRCPC, Study Director, Affiliation: Children's Hospital of Eastern Ontario
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Pain of Procedure Rating
Secondary outcome: Wound CosmesisEase of procedure as measured by treating physician
Eligibility
Minimum age: N/A.
Maximum age: 17 Years.
Gender(s): Both.
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
Locations and Contacts
Children's Hospital of Eastern Ontario, Ottawa, Ontario K1H 8L1, Canada
Additional Information
Starting date: April 2011
Last updated: April 9, 2013
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