Prospective Evaluation of Topical Analgesia for Laceration Repair in the Emergency Department

Centre Hospitalier le Mans132 enrolled

Overview

The purpose of this study is to determine if topical analgesia using a lidocaine and prilocaine cream improves pain scores compared to the usual local anesthesia using subcutaneous 1% lidocaine and adrenalin injected near the laceration.

A prospective randomized open clinical trial conducted in two high volume emergency departments in France. Adult patients presenting for laceration repair by suture will be allocated, after consent is obtained, on a one to one basis using a randomisation by minimisation method. 126 patients are expected to enrol in the study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

132

Conditions

Pain, Acute Laceration

Interventions

Lidocaine-Prilocaine Cream 2.5-2.5%DRUG

Topical anesthesia using a cream containing 2.5% Lidocaine and 2.5 % Prilocaine for at least 30 minutes on and around the wound before suture

Lidocaine 1% Epinephrine 0.005mg/mL solutionDRUG

Local anesthesia by subcutaneous injection of a solution containing 1% Lidocaine and 0.005mg/mL Epinephrine in and around the wound in the minutes preceding the suture of the wound

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Superficial skin laceration requiring a suture Exclusion Criteria: * Known allergy to lidocaine * Mucous membrane or eye wound * Nose, ear or perineal wound * Active hemorrhage in the wound * Dirty or infected wound * Wound requiring operation room management * Distracting pain in an other location * Intoxicated or comatose patient * Patient Under guardianship * Contra-indication to Lidocaine/Prilocaine cream: hypersensitivity, glucose-6-phosphate deficiency, idiopathic methemoglobinemia * Neurologic disorder affecting pain sensitivity * Dementia * Pregnancy, breast feeding, absence of contraceptive measures for women of childbearing age * Absence of signed informed consent * Inclusion in an other interventional clinical protocol

Locations (2)

Centre Hospitalier Universitaire Angers

Angers, France

Centre Hospitalier Le Mans

Le Mans, France

Outcomes

Primary Outcomes

Maximum pain

Maximum pain on the numerical pain scale (0-10) during laceration management (anesthesia, exploration and suture of the laceration).

Time frame: 60 minutes

Secondary Outcomes

Patient satisfaction

Patient satisfaction relating to the pain management measured on a four point Likert scale.

Time frame: 60 minutes

Topical anesthesia failure rate

Percentage of patients in the intervention group who required additional anesthesia by subcutaneous injection of Lidocaine/Epinephrine

Time frame: 60 minutes

Pain management during the various stages of care

Maximum pain measured on the numerical pain scale (0-10) measured on admission to the emergency department, during the wait for laceration treatment, during the wound cleansing for the intervention group and during anesthesia for the control group, during suture.

Time frame: 60 minutes

Management duration

Mean duration of management between admission to the emergency department and discharge.

Time frame: 60 minutes

Adverse effects

Evaluation of adverse effects due to the anesthesia technique (e.g. allergic reactions) by a telephone interview 15 days after initial management

Time frame: 15 days

Wound healing

Evaluation of the quality of wound healing during a telephone interview by identifying signs of wound infection and/or wound reopening.

Time frame: 15 days

Data from ClinicalTrials.gov

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