Comparing Low Dose IV Ketamine-midazolam Versus IV Morphine Regarding ED Pain Control in Patients Sustaining Closed Limb Fracture(s)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 236
- 主要终点
- VAPS
研究概览
简要总结
the investigators assessed the effects of low-dose IV ketamine-midazolam versus morphine on pain control in trauma patients with closed limb fracture(s); and also compared the incidence of adverse events (mainly cardio pulmonary ) between two groups.
详细描述
this prospective, single blind, noninferiority trial randomized consecutive ED patients aged 18 to 60 years to two groups: receiving either 300-500 mcg ketamine plus 0.03 mg midazolam, or 0.05 to 0.1 mg morphine. Visual analogue score and adverse events were carefully verified during an interval of 30 minutes.
Two hundreds, thirty six patients were selected, among whom were 207 males (87.3%), and 29 females (12.2%). The average age was 29±2, with extremes of 60 years and 18 years.the patients were divided into two groups: G1: 116 patients receiving ketamine-midazolam and G2: 120 patients receiving morphine alone.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 18 and 60 years
- •Patients with closed limb fracture(s)
- •VAS score of at least 6
排除标准
- •Acute pulmonary infection
- •Previous coronary artery diseases,ACS,congestive heart failure,
- •suspected aortic dissection
- •History of uncontrolled hypertention or blood pressure > 140/90mmHg
- •Brain injury with focal neurological deficit or loss of consciousness
- •Central nervous system mass lesion,hydrocephalus, or other states with increased intracranial pressure
- •Glaucoma and acute globe injury
- •History of porphyria
- •Previous hyperthyroidism or thyroid hormone replacement
- •Pregnancy or laction
- •Major psychiatric disorder
- •Previous allergic reaction to the agents administered in the study
- •Patient declined to provide written informed conse
研究组 & 干预措施
Ketamine-midazolam
300 to 500 mcg/kg ketamine plus 0.03 mg/kg midazolam
干预措施: Ketamine-midazolam (Drug)
Morphine
0.05 to 0.1 mg/kg morphine
干预措施: Morphine (Drug)
结局指标
主要结局
VAPS
时间窗: 30 minutes
the pain score was verified at the outset and every 10 minutes after administration of analgesics.
次要结局
- HR,RR,SPO2,BP(30 minutes)
研究者
Mehdi Nasr Isfahani
Mehdi Nasr Isfahani
Isfahan University of Medical Sciences