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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003334-33 | EudraCT Number |
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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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The purpose of this study is to determine whether topical application of Ropivacaine is effective for treating refractory pain during dressing changes and so improve quality of life of patients (newborn, child, adolescent or adults under 21) suffering from hereditary epidermal epidermolysis bullosa.
This clinical trial aims to determine the efficacy on pain of local application of ROPIVACAINE 0.2% on cutaneous lesions related to Epidermolysis Bullosa during dressing change, associated with the standard premedication.
Patients will be hospitalized and will have several baths. The first bath will be done according to usual protocol (usual premedication 1h before the bath). Pain measurements (Visual analog scale or FLACC) will be done at the entry into the water, in the middle of bath and at the time of the dressing change.
The following baths will be done using local application of Ropivacaine 15 minutes before entering into the water on lesions identified by the patients as the most painful lesions due to Epidermolysis Bullosa.
A blood test will be done during the first use of Ropivacaine to determine plasmatic level of Ropivacaine.
After 3 baths in the dermatology unit, patients will continue such bath at home, every 48h during 15 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with Hereditary Epidermolysis Bullosa | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug | Ampoules of ROPIVACAINE 2mg / ml will be used by local cutaneous application in soft application with device of "hand shower" on the painful wounds without exceeding the dose of 1mg / kg per bath. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy on pain of Ropivacaine at the bath entrance | Evaluation performed by child with a Visual Analog Scale (VAS) or by parents with the Face Legs Activity Cry Consolability questionary (FLACC) - defined by a 2 points loss between day 1 and day 5 | Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy on pain of Ropivacaine at the time of dressing change | Evaluation performed by child with a VAS or by parents with FLACC at the time of dressing changes after bathing - defined by a 2 points loss between day 1 and day 5 | Day 5 |
| Efficacy on pain of Ropivacaine at home at the time of dressing change |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine Bodemer, MD, PhD | Assistance Publique - Hôpitaux de Paris | Study Director |
| Céline Greco, MD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Necker Enfants Malades | Paris | 75015 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32939751 | Result | Moreno Artero E, Schinkel N, Chaumon S, Corset I, Rabeony T, Elie C, Bellon N, Bodemer C, Greco C. Efficacy of topical ropivacaine in children and young adults with hereditary epidermolysis bullosa. Br J Dermatol. 2021 Mar;184(3):550-552. doi: 10.1111/bjd.19551. Epub 2020 Nov 2. No abstract available. | |
| 28821470 | Result |
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| ID | Term |
|---|---|
| D004820 | Epidermolysis Bullosa |
| D010146 | Pain |
| ID | Term |
|---|---|
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Blood test | Biological | Blood test during the first bath with Ropivacaine for Titration of Ropivacaine |
|
Evaluation performed by child with a VAS or by parents with FLACC at the time of dressing changes after bathing |
| Day 21 |
| Efficacy on pain of Ropivacaine at home at bath entrance | Evaluation performed by child with a VAS or by parents with FLACC at the time of bath entrance | Day 21 |
| Measurement of Local or systemic side effects | Evaluation of tolerance of Ropivacaine | Day 5 |
| Efficacy of Ropivacaine on the reduction of opioids use | Efficacy of ROPIVACAINE on the reduction of weak or strong opioids consumption for premedication for the bath and dressing change | Day 21 |
| Efficacy of Ropivacaine on the reduction of benzodiazepines or hypnotics use | Efficacy of ROPIVACAINE on the reduction of of benzodiazepines or hypnotics consumption for premedication for the bath and dressing change | Day 21 |
| Systemic passage of Ropivacaine | Evaluation of the systemic passage of Ropivacaine | Blood test during the first bath with Ropivacaine up to Day 4 |
| Chevret S, Verlhac S, Ducros-Miralles E, Dalle JH, de Latour RP, de Montalembert M, Benkerrou M, Pondarre C, Thuret I, Guitton C, Lesprit E, Etienne-Julan M, Elana G, Vannier JP, Lutz P, Neven B, Galambrun C, Paillard C, Runel C, Jubert C, Arnaud C, Kamdem A, Brousse V, Missud F, Petras M, Doumdo-Divialle L, Berger C, Freard F, Taieb O, Drain E, Elmaleh M, Vasile M, Khelif Y, Bernaudin M, Chadebech P, Pirenne F, Socie G, Bernaudin F. Design of the DREPAGREFFE trial: A prospective controlled multicenter study evaluating the benefit of genoidentical hematopoietic stem cell transplantation over chronic transfusion in sickle cell anemia children detected to be at risk of stroke by transcranial Doppler (NCT 01340404). Contemp Clin Trials. 2017 Nov;62:91-104. doi: 10.1016/j.cct.2017.08.008. Epub 2017 Aug 15. |
| D030342 | Genetic Diseases, Inborn |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012872 | Skin Diseases, Vesiculobullous |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |