A non-inferiority study of the clinical effectiveness of anaesthesia obtained via application of Topical Anaesthetic Gel compared to infiltration of lidocaine for the treatment of lacerations in the Emergency Department

Conditions: Small to medium sized lacerations with no underlying nerve or other gross structural damage which would require further medical or surgical investigation.
MedDRA version: 9.1Level: LLTClassification code 10023572Term: Laceration

Registration Number: EUCTR2008-002467-13-GB

Lead Sponsor: orthern Health and Social Care Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 110

Inclusion Criteria

Adult patients (18 years of age or older) who attend the Emergency Department at Antrim Hospital for treatment of a laceration.
Potential participants must have a laceration that requires sutures.
Patients must provide written informed consent to participate.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients who attend with wounds that can be approximated by tissue adhesives or steristrips.
Patients who attend with animal or human bites or wounds which show gross contamination.
Patients with puncture or crush wounds and scalp lacerations will also be excluded. Wounds occurring across joints and lacerations of tendon, nerve or cartilage.
Patients with systemic disease including; collagen vascular disease, immunodeficiency, HIV, skin disorders, diabetes mellitus or bleeding disorders.
Patients taking warfarin or drugs that cause methaemoglobinaemia.
Patients who are allergic to either lidocaine or any of the other formulation ingredients.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the pain recorded on testing (using a visual analogue scale) after treatment with either Topical Anaesthetic Gel for 30 minutes or 15 minutes after infiltration with 1% w/v lidocaine hydrochloride.;Primary end point(s): The primary end point is pain recorded on testing using a visual analogue scale (range 0-10). ;Secondary Objective: To compare the need for rescue anaesthetic in the two groups. To compare the levels of infection and dehiscence of the wounds in the two groups. To compare the values obtained in the wound evaluation score 7-10 days after suturing and the time from the start until the end of treatment. In addition, the quality of wound repair will be assessed by a blinded investigator being asked to comment upon photographs of the finished result.

Secondary Outcome Measures