Evaluation of the Efficacy of ROPIVACAINE in Children and Young Adults With Hereditary Epidermolysis Bullosa

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of the Efficacy of a Topical Analgesic Treatment With ROPIVACAINE in Children and Young Adults With Hereditary Epidermolysis Bullosa

Conditions
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Epidermolysis Bullosa

Intervention / Treatment
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* Drug: Ropivacaine
* Biological: Blood test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Minor patient or adult ≤ 21 years of age with hereditary epidermolysis bullosa, Presenting pain at the entrance of the bath with an average of EVA or FLACC greater than 4/10 the week before the inclusion Usually requiring premedication with weak or strong opioid Parental consent if minor or patient consent Affiliated with Social Security Exclusion Criteria: Patient with a known allergy to ROPIVACAINE or other local anesthetics with amide binding or one of the excipients mentioned in the SPC Severe renal insufficiency defined by DFG below 29ml / min Moderate to severe hepatic insufficiency defined by a Child-Pugh B or C score and AST or ALAT greater than 3 times normal Moderate to severe cardiac failure defined by FEGV less than 45% and/or NYHA class II to IV Hypovolemia

Ages Eligible for Study
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Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient with Hereditary Epidermolysis Bullosa<br> | Drug: Ropivacaine<br>* 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.<br>Biological: Blood test<br>* Blood test during the first bath with Ropivacaine for Titration of Ropivacaine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hereditary Epidermolysis Bullosa, pain, bath, dressing change, Ropivacaine, topical application