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| Name | Class |
|---|---|
| University Hospital, Angers | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical anesthesia | Experimental | Topical anesthesia using a cream containing 2.5% Lidocaine and 2.5% Prilocaine applied for at least 30 minutes before laceration repair. |
|
| Subcutaneous injection anesthesia | Experimental | Local anesthesia by a subcutaneous injection of a solution containing 1% Lidocaine and 0.005 mg/mL Epinephrine in the minutes before laceration repair. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine-Prilocaine Cream 2.5-2.5% | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum pain | Maximum pain on the numerical pain scale (0-10) during laceration management (anesthesia, exploration and suture of the laceration). | 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction | Patient satisfaction relating to the pain management measured on a four point Likert scale. | 60 minutes |
| Topical anesthesia failure rate | Percentage of patients in the intervention group who required additional anesthesia by subcutaneous injection of Lidocaine/Epinephrine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julien Fonsegrive, MD | Centre Hospitalier le Mans | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire Angers | Angers | 49 000 | France | |||
| Centre Hospitalier Le Mans |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22694845 | Result | 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. | |
| 15572968 | Result | 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. |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D022125 | Lacerations |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D004837 | Epinephrine |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Lidocaine 1% Epinephrine 0.005mg/mL solution | Drug | 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 |
|
| 60 minutes |
| 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 |
| Management duration | Mean duration of management between admission to the emergency department and discharge. | 60 minutes |
| 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 |
| 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 |
| Le Mans |
| 72 000 |
| France |
| D014947 | Wounds and Injuries |
| Aniline Compounds |
| D000588 | Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004364 | Pharmaceutical Preparations |