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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Centre Hospitalier le Mans

Current Primary Outcome: Maximum pain [ Time Frame: 60 minutes ]

Maximum pain on the numerical pain scale (0-10) during laceration management (anesthesia, exploration and suture of the laceration).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Patient satisfaction [ Time Frame: 60 minutes ]
    Patient satisfaction relating to the pain management measured on a four point Likert scale.
  • Topical anesthesia failure rate [ Time Frame: 60 minutes ]
    Percentage of patients in the intervention group who required additional anesthesia by subcutaneous injection of Lidocaine/Epinephrine
  • Pain management during the various stages of care [ Time Frame: 60 minutes ]
    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.
  • Management duration [ Time Frame: 60 minutes ]
    Mean duration of management between admission to the emergency department and discharge.
  • Adverse effects [ Time Frame: 15 days ]
    Evaluation of adverse effects due to the anesthesia technique (e.g. allergic reactions) by a telephone interview 15 days after initial management
  • Wound healing [ Time Frame: 15 days ]
    Evaluation of the quality of wound healing during a telephone interview by identifying signs of wound infection and/or wound reopening.


Original Secondary Outcome: Same as current

Information By: Centre Hospitalier le Mans

Dates:
Date Received: February 17, 2017
Date Started: April 1, 2017
Date Completion: April 2, 2018
Last Updated: March 1, 2017
Last Verified: March 2017