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 ]
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