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

• Status: Completed
• Trial end date: 2019-11-28
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Ropivacaine

Criteria

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