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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-27

Study Completion Date

2019-11-28

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.

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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.

Conditions

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Epidermolysis Bullosa

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patient with Hereditary Epidermolysis Bullosa

Group Type EXPERIMENTAL

Ropivacaine

Intervention Type DRUG

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.

Blood test

Intervention Type BIOLOGICAL

Blood test during the first bath with Ropivacaine for Titration of Ropivacaine

Interventions

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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.

Intervention Type DRUG

Blood test

Blood test during the first bath with Ropivacaine for Titration of Ropivacaine

Intervention Type BIOLOGICAL

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

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No