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COMPLETEDPhase 4NCT03071601

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

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 ad...

Lead sponsor: Centre Hospitalier le Mans•2 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Centre Hospitalier le Mans

Collaborators

University Hospital, Angers

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.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: March 10, 2022Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE4

Enrollment132

Start dateDec 2017

Last updatedMar 10, 2022

Condition

Pain, Acute Laceration

Locations shown

Centre Hospitalier Universitaire Angers

Angers

Centre Hospitalier Le Mans

Le Mans

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2022Data synced to Clareo: July 13, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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