Gluing Lacerations Utilizing Epinephrine - Full Text View

Purpose

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.

Condition	Intervention	Phase
Lacerations	Drug: LET - Lidocaine Epinephrine Tetracaine	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Epinephrine bitartrate Epinephrine Epinephrine hydrochloride Lidocaine hydrochloride Tetracaine Tetracaine hydrochloride Lidocaine Racepinephrine hydrochloride Racepinephrine

U.S. FDA Resources

Further study details as provided by Children's Hospital of Eastern Ontario:

Primary Outcome Measures:

Pain of Procedure Rating [ Time Frame: 2 minutes post-procedure ] [ Designated as safety issue: No ]
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).

Secondary Outcome Measures:

Wound Cosmesis [ Time Frame: measured at 3 month f/u visit ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Immediately after the procedure, the treating physician will rate how easy the repair was on a 100 mm Visual Analog Scale.

Enrollment:	222
Study Start Date:	April 2011
Study Completion Date:	April 2012
Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Pre-treatment with LET Pre-treatment with Lidocaine Epinephrine Tetracaine solution at least 45 minutes prior to laceration repair with tissue adhesive	Drug: LET - Lidocaine Epinephrine Tetracaine One time application of 3 cc of Lidocaine Epinephrine Tetracaine Solution at least 45 minutes prior to laceration repair Other Names: LAT Lidocaine Adrenaline Tetracaine
Placebo Comparator: Pre-treatment with Placebo Pre-treatment with Placebo solution at least 45 minutes prior to laceration repair with tissue adhesive	Drug: LET - Lidocaine Epinephrine Tetracaine One time application of 3 cc of Lidocaine Epinephrine Tetracaine Solution at least 45 minutes prior to laceration repair Other Names: LAT Lidocaine Adrenaline Tetracaine

Eligibility

Ages Eligible for Study:	up to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01202487

Locations

Canada, Ontario
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1

Sponsors and Collaborators

Children's Hospital of Eastern Ontario

Investigators

Principal Investigator:	Stuart GS Harman, MD FRCPC	Children's Hospital of Eastern Ontario
Study Director:	Roger Zemek, MD FRCPC	Children's Hospital of Eastern Ontario

More Information

No publications provided

Responsible Party:	Stuart Harman, Dr. Stuart Harman MD FRCPC, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier:	NCT01202487 History of Changes
Other Study ID Numbers:	6138378804
Study First Received:	September 14, 2010
Last Updated:	April 9, 2013
Health Authority:	Canada: Health Canada

Keywords provided by Children's Hospital of Eastern Ontario:

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

Additional relevant MeSH terms:

Lacerations
Wounds and Injuries
Epinephrine
Epinephryl borate
Lidocaine
Tetracaine
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents

Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Central Nervous System Agents
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on May 16, 2013

Gluing Lacerations Utilizing Epinephrine (GLUE)