Clinical trial NCT03071601: Prospective Evaluation of Topical Analgesia for Laceration Repair in the Emergency Department
Official title: Prospective Evaluation of Topical Analgesia Using a Lidocaine/Prilocaine Cream for Laceration Repair in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Acute
Laceration
Keywords: Laceration
Suture
Topical anesthesia
Lidocaine
Lead sponsor: Centre Hospitalier le Mans
Sponsor class: OTHER
Collaborators: name: University Hospital, Angers
First posted: 2017-03-07
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximum pain
timeFrame: 60 minutes
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 60 minutes
measure: Topical anesthesia failure rate
timeFrame: 60 minutes
measure: Pain management during the various stages of care
timeFrame: 60 minutes
measure: Management duration
timeFrame: 60 minutes
measure: Adverse effects
timeFrame: 15 days
measure: Wound healing
timeFrame: 15 days
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre Hospitalier Universitaire Angers
city: Le Mans
country: France
facility: Centre Hospitalier Le Mans
Study officials:
affiliation: Centre Hospitalier le Mans
name: Julien Fonsegrive, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McNulty RJ, Handley TP, Devlin MF. Reducing the need for general anaesthesia in children: use of LAT gel in treating facial lacerations. Br J Oral Maxillofac Surg. 2013 Sep;51(6):e130-1. doi: 10.1016/j.bjoms.2012.04.259. Epub 2012 Jun 12.
citation: White NJ, Kim MK, Brousseau DC, Bergholte J, Hennes H. The anesthetic effectiveness of lidocaine-adrenaline-tetracaine gel on finger lacerations. Pediatr Emerg Care. 2004 Dec;20(12):812-5. doi: 10.1097/01.pec.0000148029.61222.9f.