NCT03071601

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

Prospective Evaluation of Topical Analgesia Using a Lidocaine/Prilocaine Cream for Laceration Repair in the Emergency Department

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Centre Hospitalier le Mans · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Pain, Acute
• Laceration

Interventions

Type	Name	Description
DRUG	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
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

Timeline

• Start date: 2017-12-01
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2017-03-07
• Last updated: 2022-03-10

Locations

2 sites across 1 country: France