Evaluation of the Efficacy of a Topical Analgesic Treatment With ROPIVACAINE in Children and Young Adults With Hereditary Epidermolysis Bullosa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Efficacy on pain of Ropivacaine at the bath entrance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Patient with Hereditary Epidermolysis Bullosa
干预措施: Ropivacaine (Drug)
Patient with Hereditary Epidermolysis Bullosa
干预措施: Blood test (Biological)
结局指标
主要结局
Efficacy on pain of Ropivacaine at the bath entrance
时间窗: 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
次要结局
- Efficacy on pain of Ropivacaine at home at bath entrance(Day 21)
- Efficacy of Ropivacaine on the reduction of opioids use(Day 21)
- Efficacy of Ropivacaine on the reduction of benzodiazepines or hypnotics use(Day 21)
- Systemic passage of Ropivacaine(Blood test during the first bath with Ropivacaine up to Day 4)
- Efficacy on pain of Ropivacaine at the time of dressing change(Day 5)
- Efficacy on pain of Ropivacaine at home at the time of dressing change(Day 21)
- Measurement of Local or systemic side effects(Day 5)