RePPAIR -Reducing Procedural Pain and Improving Recovery of Quality of Life in Pediatric Neuroblastoma Patients Undergoing Bone Marrow Procedures: A Prospective Randomized Cross-over Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Number of Participants Requiring Post-procedural Opioid Analgesia Per Study Arm
研究概览
简要总结
The purpose of this study is to identify whether or not the addition of a numbing medicine that is injected directly into the site of the bone marrow procedure can reduce pain and the use of opioid pain medication after bone marrow procedures. The addition of this medicine, called ropivacaine, is the experimental part of this study. This is the first time ropivacaine will be directly injected into the bone marrow site at MSKCC Pediatrics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of neuroblastoma as defined by the International Neuroblastoma Risk Group Staging System (INRGSS)22
- •3 - 18 years of age
- •Patient has had prior bone marrow procedures
- •English speaking
排除标准
- •History of allergy to investigational agent: ropivacaine or other amino amide analgesics
- •History of allergy to standard agent: propofol
- •Chronic daily opioid requirement
- •Lansky/Karnofsky Score < 60
- •Inability to comply with protocol requirements including refusal to forego pre-procedural opioid use
- •Patient is receiving additional potentially painful interventions (e.g. central line insertion/removal) concurrent with the bone marrow procedure
研究组 & 干预措施
Propofol First, then Propofol & Ropivacaine
1st Bone Marrow procedure (BM) Intervention A: propofol first. Then second BM procedure with propofol & ropivacaine
干预措施: propofol (Device)
Propofol First, then Propofol & Ropivacaine
1st Bone Marrow procedure (BM) Intervention A: propofol first. Then second BM procedure with propofol & ropivacaine
干预措施: Wong-Baker FACES® Pain Rating Scale (Behavioral)
Propofol First, then Propofol & Ropivacaine
1st Bone Marrow procedure (BM) Intervention A: propofol first. Then second BM procedure with propofol & ropivacaine
干预措施: Post-procedural quality of life (QOL) (Behavioral)
Propofol and Ropivacaine First, then Propofol
1st BM procedure: Intervention B: propofol & ropivacaine first. Then second BM procedure with propofol
干预措施: ropivacaine (Drug)
Propofol and Ropivacaine First, then Propofol
1st BM procedure: Intervention B: propofol & ropivacaine first. Then second BM procedure with propofol
干预措施: Wong-Baker FACES® Pain Rating Scale (Behavioral)
Propofol and Ropivacaine First, then Propofol
1st BM procedure: Intervention B: propofol & ropivacaine first. Then second BM procedure with propofol
干预措施: Post-procedural quality of life (QOL) (Behavioral)
结局指标
主要结局
Number of Participants Requiring Post-procedural Opioid Analgesia Per Study Arm
时间窗: within 24 hours (+/- 4 hours) post procedure
Number of participants requiring post-procedural opioid analgesia within 24 hours (+/- 4 hours) post procedure per study arm
次要结局
未报告次要终点