Intravenous Subdissociative-dose Ketamine Versus Morphine for Prehospital Analgesia a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 285
- 试验地点
- 12
- 主要终点
- Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 30 minutes post first injection.
研究概览
简要总结
This is a prospective, randomized, single-blind trial evaluating prehospital patients experiencing moderate to severe acute pain, defined as a numeric rating scale score greater than or equal to 5. Patients will be randomized to receive ketamine at or morphine by intravenous push.
详细描述
This study is designed to evaluate if ketamine alone is non inferior to morphine alone for prehospital analgesia. Numeric rating scale pain scores will be compared between recipients of ketamine and recipients of morphine at 15, 30, 45 and 60 min post first injection and at hospital admission.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •older than 18 years old
- •prehospital moderate to severe acute pain, defined as a numeric rating scale score greater than or equal to 5
排除标准
- •unstable vital signs (systolic blood pressure <90 or >200 mm Hg, pulse rate <50 or >150 beats/min, and respiration rate <10 or >30 breaths/min)
- •pregnancy
- •breast-feeding
- •altered mental status
- •unable to give numeric rating scale scores
- •allergy to morphine or ketamine
- •acute pulmonary edema
- •acute coronary syndrome
- •renal or hepatic insufficiency
- •patient who received morphine for the same acute pain
- •acute psychiatric illness
研究组 & 干预措施
Ketamine IV
干预措施: Ketamine (Drug)
Morphine IV
干预措施: Morphine (Drug)
结局指标
主要结局
Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 30 minutes post first injection.
时间窗: 30 minutes
次要结局
- Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 15 minutes post first injection.(15 minutes)
- Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 45 minutes post first injection.(45 minutes)
- Comparison of numeric rating scale pain scores between recipients of ketamine and morphine at 60 minutes post first injection.(60 minutes)