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

Pain, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03071601
• Other study ID #: CHM-2016-S2/04
• Status: Completed
• Phase: Phase 4
• Start date: December 1, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2022
• Source: Centre Hospitalier le Mans
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Emergencies
• Laceration
• Lacerations
• Pain, Acute

Intervention

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
• 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

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire Angers	Angers
France	Centre Hospitalier Le Mans	Le Mans

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier le Mans	University Hospital, Angers

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum pain	Maximum pain on the numerical pain scale (0-10) during laceration management (anesthesia, exploration and suture of the laceration).	60 minutes
Secondary	Patient satisfaction	Patient satisfaction relating to the pain management measured on a four point Likert scale.	60 minutes
Secondary	Topical anesthesia failure rate	Percentage of patients in the intervention group who required additional anesthesia by subcutaneous injection of Lidocaine/Epinephrine	60 minutes
Secondary	Pain management during the various stages of care	Maximum pain measured on the numerical pain scale (0-10) measured on admission to the emergency department, during the wait for laceration treatment, during the wound cleansing for the intervention group and during anesthesia for the control group, during suture.	60 minutes
Secondary	Management duration	Mean duration of management between admission to the emergency department and discharge.	60 minutes
Secondary	Adverse effects	Evaluation of adverse effects due to the anesthesia technique (e.g. allergic reactions) by a telephone interview 15 days after initial management	15 days
Secondary	Wound healing	Evaluation of the quality of wound healing during a telephone interview by identifying signs of wound infection and/or wound reopening.	15 days