Intra-nasal Ketamine for Analgesia in the Emergency Department
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Proportion of subjects achieving a 13mm or more reduction in pain as measured on a 100-mm VAS within 30 minutes.
研究概览
简要总结
The provision of analgesia to patients in pain is a fundamental necessity of emergency department practice and is usually accomplished using IV opioids. However, significant barriers exist to the provision of timely analgesia by the IV route.
The use of the IN route for medication delivery provides an efficient and relatively painless mode of analgesia delivery. As well, ketamine is well-known to be an effective analgesic and to preserve cardiorespiratory function thus removing the necessity of physiologic monitoring that is obligatory when using opioids. The use of ketamine by the IN route provides a rapid, easy-administered and well-tolerated method for providing analgesia in the ED setting.
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
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 6 years or greater
- •moderate or severe pain (VAS >=50mm)
排除标准
- •history of allergy or intolerance to ketamine
- •structural or functional nasal occlusion
- •inability to understand the VAS
- •Glasgow Coma Scale < 15
- •Systolic BP > 180
- •History of schizophrenia
- •Clinical necessity for immediate IV access as judged by the treating physician
研究组 & 干预措施
Intra-nasal ketamine
0.5 mg/kg ketamine intra-nasally; then 0.25 mg/kg repeat dose after 10 minutes if necessary
干预措施: Intra-nasal ketamine (Drug)
结局指标
主要结局
Proportion of subjects achieving a 13mm or more reduction in pain as measured on a 100-mm VAS within 30 minutes.
时间窗: 30 minutes
次要结局
- Median maximum reduction in VAS pain score achieved within 30 minutes(30 minutes)
- Median time required to achieve a 13-mm reduction in VAS pain score(1 hour)
- Vital signs changes (ETCO2, O2sat, HR, RR, BP)(1 hour)
- Adverse effects as defined by SERSDA(1 hour)
研究者
Gary Andolfatto
Assistant Professor, University of British Columbia Department of Emergency Medicine; Attending Physician and Emergency Department Research Director, Lions Gate Hospital
Lions Gate Hospital