Prospective Evaluation of Topical Analgesia for Laceration Repair in the Emergency Department
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|ClinicalTrials.gov Identifier: NCT03071601|
Recruitment Status : Recruiting
First Posted : March 7, 2017
Last Update Posted : January 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pain, Acute Laceration||Drug: Lidocaine-Prilocaine Cream 2.5-2.5% Drug: Lidocaine 1% Epinephrine 0.005mg/mL solution||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Evaluation of Topical Analgesia Using a Lidocaine/Prilocaine Cream for Laceration Repair in the Emergency Department|
|Actual Study Start Date :||December 1, 2017|
|Estimated Primary Completion Date :||September 1, 2019|
|Estimated Study Completion Date :||December 2, 2019|
Experimental: Topical anesthesia
Topical anesthesia using a cream containing 2.5% Lidocaine and 2.5% Prilocaine applied for at least 30 minutes before laceration repair.
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
Experimental: Subcutaneous injection anesthesia
Local anesthesia by a subcutaneous injection of a solution containing 1% Lidocaine and 0.005 mg/mL Epinephrine in the minutes before laceration repair.
Drug: 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
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03071601
|Contact: Christelle Jadeau, PD||0 (33) 2 43 43 43 43 ext 37 email@example.com|
|Contact: Jean-Christophe Callahan, MD||0 (33) 2 43 43 43 43 ext 37 firstname.lastname@example.org|
|Centre Hospitalier Universitaire Angers||Recruiting|
|Angers, France, 49 000|
|Contact: Marion Lepottier Cerruti, MD 0241353637 email@example.com|
|Centre Hospitalier Le Mans||Recruiting|
|Le Mans, France, 72 000|
|Contact: Christelle Jadeau, PD 0 (33) 2 43 43 43 43 ext 37 482 firstname.lastname@example.org|
|Contact: Jean-Christophe Callahan, MD 0 (33) 2 43 43 43 43 ext 37 520 email@example.com|
|Principal Investigator:||Julien Fonsegrive, MD||Centre Hospitalier le Mans|