A Pilot Study on the Effects of Intravenous Ketamine on Acute Pain Crisis in Patients With Sickle Cell Disease
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Assessing pain scores within 48 hours after administration of the drug. Assessing decrease in pain and increase in mobility.
研究概览
简要总结
The purpose of this pilot study is to provide a preliminary assessment of the feasibility and efficacy of intravenous ketamine in controlling pain in patients with sickle cell disease (who are admitted to the hospital with severe, acute pain crisis, and who have been resistant to intravenous narcotics).
详细描述
It is often difficult to manage acute painful crisis in patients with sickle cell disease. The usual management of these crises relies on hydration, administration of oxygen and narcotics, like morphine. A select group of patients, for unknown reasons, does not respond to this management and these patients often require prolonged use (several days) of intravenous narcotics. Narcotics have proven to be ineffective in controlling this type of pain and can cause multiple side effects (sedation, vomiting, respiratory depression). We propose to administer intravenous ketamine in this group of patients who are resistant to intravenous narcotics. Ketamine has been proven to be effective in controlling pain in multiple clinical situations. However, there are no data in the literature describing its use in patients with sickle cell disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children ages 7 to <19
- •Acute vaso-occlusive crisis
- •Persistent pain despite initial pain management with intravenous (IV) opioids
排除标准
- •Contraindications to the use of ketamine
- •Mental retardation or psychological conditions that may affect the proper evaluation of pain and side effects
- •Known allergy to ketamine
研究组 & 干预措施
1
Patients receiving ketamine are those patients, arm 1, that are sill experiencing pain after Morphine has been given.
干预措施: Ketamine (Drug)
结局指标
主要结局
Assessing pain scores within 48 hours after administration of the drug. Assessing decrease in pain and increase in mobility.
时间窗: 48 hours
次要结局
未报告次要终点
