A Randomised Controlled Trial Comparing the procedural sedative and analgesic actions of ketofol and etofen during procedures in the emergency department
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- 1) Pain severity (visual analogue scale) 2) Adequacy of sedation and analgesia between two groups (Modified Ramsay Sedation Score) 3) Incidence of airway adverse events
研究概览
简要总结
Procedural sedation and analgesia is the technique of administering sedatives or dissociative agents with or without analgesics to induce an altered state of consciousness that allows the patient painful and unpleasant procedures while preserving cardiorespiratory function.Recommended drugs for PSA propofol, ketamine, ketofol, alfentanyl,etofen.Procedures done commonly in emergency room include fracture reductions, intercostal tube drainage insertions, incision and drainage of abscess and other painful procedures requiring sedation and analgesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •All patients who decided to receive PSA for procedures and ASA physical status 1 or 2.
排除标准
- •Hypersensitivity to Ketofol or Etofen 2)Age less than 18 years 3)ASA 3 and 4.
结局指标
主要结局
1) Pain severity (visual analogue scale) 2) Adequacy of sedation and analgesia between two groups (Modified Ramsay Sedation Score) 3) Incidence of airway adverse events
时间窗: 5 minutes
次要结局
- To compare the other adverse effects between two groups (additional drug needed, sedation duration, sedation level and patient pain and physicians satisfaction scores) 2) To determine the alterations in hemodynamic changes between two groups
