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

Centre Hospitalier le Mans

Status and phase: Completed; Phase 4

Conditions: Pain, Acute; Laceration

Treatments: Drug: Lidocaine 1% Epinephrine 0.005mg/mL solution; Drug: Lidocaine-Prilocaine Cream 2.5-2.5%

Study type: Interventional

Funder types: Other

Identifiers

NCT03071601

CHM-2016-S2/04

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 132 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

132 participants in 2 patient groups

Topical anesthesia

Experimental group

Description:

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

Treatment:

Drug: Lidocaine-Prilocaine Cream 2.5-2.5%

Subcutaneous injection anesthesia

Experimental group

Description:

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

Treatment:

Drug: Lidocaine 1% Epinephrine 0.005mg/mL solution