Evaluation of the Efficacy of ROPIVACAINE in Children and Young Adults With Hereditary Epidermolysis Bullosa (EBROPI)
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|ClinicalTrials.gov Identifier: NCT03730584|
Recruitment Status : Recruiting
First Posted : November 5, 2018
Last Update Posted : April 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Epidermolysis Bullosa||Drug: Ropivacaine Biological: Blood test||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Efficacy of a Topical Analgesic Treatment With ROPIVACAINE in Children and Young Adults With Hereditary Epidermolysis Bullosa|
|Actual Study Start Date :||February 27, 2017|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||August 2020|
- Drug: Ropivacaine
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.
- Biological: Blood test
Blood test during the first bath with Ropivacaine for Titration of Ropivacaine
- Efficacy on pain of Ropivacaine at the bath entrance [ Time Frame: Day 5 ]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
- Efficacy on pain of Ropivacaine at the time of dressing change [ Time Frame: Day 5 ]Evaluation performed by child with a VAS or by parents with FLACC at the time of dressing changes after bathing
- Efficacy on pain of Ropivacaine at home at the time of dressing change [ Time Frame: Day 21 ]Evaluation performed by child with a VAS or by parents with FLACC at the time of dressing changes after bathing
- Efficacy on pain of Ropivacaine at home at bath entrance [ Time Frame: Day 21 ]Evaluation performed by child with a VAS or by parents with FLACC at the time of bath entrance
- Measurement of Local or systemic side effects [ Time Frame: Day 5 ]Evaluation of tolerance of Ropivacaine
- Efficacy of Ropivacaine on the reduction of opioids use [ Time Frame: Day 21 ]Efficacy of ROPIVACAINE on the reduction of weak or strong opioids consumption for premedication for the bath and dressing change
- Efficacy of Ropivacaine on the reduction of benzodiazepines or hypnotics use [ Time Frame: Day 21 ]Efficacy of ROPIVACAINE on the reduction of of benzodiazepines or hypnotics consumption for premedication for the bath and dressing change
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): NCT03730584
|Contact: Céline Greco, MD||+33 1 42 19 27 email@example.com|
|Contact: Nelly Briand, PhD||+33 1 44 38 18 firstname.lastname@example.org|
|Hôpital Necker Enfants Malades||Recruiting|
|Paris, France, 75015|
|Contact: Céline Gréco, MD +33 1 42 19 27 28 email@example.com|
|Study Director:||Christine Bodemer, MD, PhD||Assistance Publique - Hôpitaux de Paris|