Pain, Acute Clinical Trial
Official title:
Prospective Evaluation of Topical Analgesia Using a Lidocaine/Prilocaine Cream for Laceration Repair in the Emergency Department
Verified date | March 2022 |
Source | Centre Hospitalier le Mans |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier Universitaire Angers | Angers | |
France | Centre Hospitalier Le Mans | Le Mans |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier le Mans | University Hospital, Angers |
France,
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
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 |
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