Ketamine in Chronic Kid's (KiCK) Pain
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Number of Participants With Dose Limiting Toxicity
研究概览
简要总结
This study is designed to select the most tolerable dose of oral ketamine for children with chronic pain. Children will be given either placebo or one of three dosages of oral ketamine for 2 weeks. The dosage that is most tolerable will be selected for further study.
详细描述
Children with chronic pain are randomized to one of four arms (three study drug arms, one placebo arm) in a randomized, double-blinded fashion. Children are treated for 2 weeks and then monitored for an additional 12 weeks. Study participation is a total of 14 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject, parent, or guardian willing and able to give informed consent
- •NRS for pain over the past 24 hours >4 at baseline
- •Chronic pain, which has been present for >3 months, or persisting longer than is normal for the underlying diagnosis
- •Chronic pain related to physiologic diagnoses including but not limited to: cancer, rheumatologic disease, sickle cell anemia, cystic fibrosis, pancreatitis, and neuromuscular disease (e.g. Duchenne muscular dystrophy)
- •Able to tolerate and cooperate with neurocognitive assessment
- •Age 8-20 years old
排除标准
- •If they are known or suspected to have drug addiction
- •Uncontrolled psychiatric disorder such as depression, schizophrenia, or bipolar disorder
- •Uncontrolled hypertension
- •Known liver disease or elevation of AST or ALT greater than 3 times the upper limit of normal.
- •Previous intolerance or allergic reaction to ketamine
- •Pregnancy
- •Use of CYP3A4 inhibitors or inducers within the 2-week period prior the study drug administration or within 5 half-lives of the respective medication, whichever is longer, until study conclusion.
- •Consumption of grapefruit or grapefruit products from at least 2 weeks prior to study drug administration until study conclusion.
研究组 & 干预措施
Ketamine 0.25 mg/kg/dose
A 5mL solution of 0.25 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
干预措施: Ketamine (Drug)
Ketamine 0.5 mg/kg/dose
A 5mL solution of 0.5 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
干预措施: Ketamine (Drug)
Ketamine 1 mg/kg/dose
A 5mL solution of 1 mg/kg/dose of ketamine will be given three times daily for 2 weeks.
干预措施: Ketamine (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Dose Limiting Toxicity
时间窗: 2 weeks
A total of 7 patients enrolled on the trial. However, 2 participants withdrew from the trial before they were randomized and 1 participant withdrew from the trial before being treated. Hence, the total number of patients for assessment is 4.
次要结局
未报告次要终点
研究者
Amy-Lee Bredlau
Director, Pediatric Brain Tumor Program
Medical University of South Carolina