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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 Cosmesis

Ease 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

Page last updated: August 23, 2015

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