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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 April 2021 |
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Main ID: |
NCT03730584 |
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Date of registration:
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02/11/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of the Efficacy of ROPIVACAINE in Children and Young Adults With Hereditary Epidermolysis Bullosa
EBROPI |
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Scientific 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 |
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Date of first enrolment:
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February 27, 2017 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03730584 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Christine Bodemer, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assistance Publique - Hôpitaux de Paris |
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Name:
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Céline Greco, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assistance Publique - Hôpitaux de Paris |
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Key inclusion & exclusion 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
Age minimum:
N/A
Age maximum:
21 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Epidermolysis Bullosa
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Intervention(s)
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Drug: Ropivacaine
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Biological: Blood test
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Primary Outcome(s)
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Efficacy on pain of Ropivacaine at the bath entrance
[Time Frame: Day 5]
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Secondary Outcome(s)
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Systemic passage of Ropivacaine
[Time Frame: Blood test during the first bath with Ropivacaine up to Day 4]
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Efficacy on pain of Ropivacaine at home at the time of dressing change
[Time Frame: Day 21]
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Efficacy of Ropivacaine on the reduction of opioids use
[Time Frame: Day 21]
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Efficacy of Ropivacaine on the reduction of benzodiazepines or hypnotics use
[Time Frame: Day 21]
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Efficacy on pain of Ropivacaine at the time of dressing change
[Time Frame: Day 5]
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Efficacy on pain of Ropivacaine at home at bath entrance
[Time Frame: Day 21]
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Measurement of Local or systemic side effects
[Time Frame: Day 5]
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Secondary ID(s)
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D20180207
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2018-003334-33
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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