Clinical trial

Topical Anaesthesia in Cutaneous Head and Neck Surgery: a Randomized Controlled Trial

Name

160123

Description

This study aims to assess if EMLA or ethyl chloride spray are effective in reducing the pain associated with local anaesthetic administration in cutaneous surgery of the head and neck compared to a placebo and control group through a randomized control trial study design.

Trial arms

Trial start

2023-02-20

Estimated PCD

2023-07-07

Trial end

2023-07-07

Status

Completed

Treatment

EMLA

EMLA cream

Arms:

EMLA cream

Ethyl chloride

Arms:

Ethyl chloride spray

Aqueous cream BP

Aqueous cream

Arms:

EMLA placebo

Size

124

Primary endpoint

Pain score

The pain score is measured essentially immediately after administration of the local anaesthetic (within 20 seconds of administration).

Eligibility criteria

Inclusion Criteria: * Aged at least 18 years * Receiving surgery to cutaneous tissues of the head and neck * Procedure performed under local anaesthetic Exclusion Criteria: * Paediatric patients * Surgery performed under general anaesthetic * Mucosal operative site (e.g. oral cavity) * Significant cognitive impairment (e.g. severe dementia) * Known sensitivity/allergy to EMLA * History of a pain disorder (e.g. complex regional pain syndrome).

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Single blinding (for participants) only for patients receiving EMLA or EMLA placebo.', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 124, 'type': 'ACTUAL'}}

Updated at

2024-02-23

1 organization

3 products

4 indications

Organization

University Hospital Waterford

Product

EMLA

Indication

Pain

Indication