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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain, Acute Laceration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Topical anesthesia

Topical anesthesia using a cream containing 2.5% Lidocaine and 2.5% Prilocaine applied for at least 30 minutes before laceration repair.

Group Type EXPERIMENTAL

Lidocaine-Prilocaine Cream 2.5-2.5%

Intervention Type 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

Subcutaneous injection anesthesia

Local anesthesia by a subcutaneous injection of a solution containing 1% Lidocaine and 0.005 mg/mL Epinephrine in the minutes before laceration repair.

Group Type EXPERIMENTAL

Lidocaine 1% Epinephrine 0.005mg/mL solution

Intervention Type DRUG

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

Interventions

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Lidocaine-Prilocaine Cream 2.5-2.5%

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

Intervention Type DRUG

Lidocaine 1% Epinephrine 0.005mg/mL solution

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No