NCT03730584

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Epidermolysis Bullosa

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-02-27
• Primary completion: 2019-11-28
• Completion: 2019-11-28
• First posted: 2018-11-05
• Last updated: 2025-11-20

Locations

1 site across 1 country: France