The Median Effective Dose (ED50) of Paracetamol and Morphine for Postoperative Patients: A Study of Interaction.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- ED50s of Paracetamol, morphine and their combination
研究概览
简要总结
The aim of our study is to define the median effective analgesic doses (ED50) of paracetamol, morphine, and their combination and determination the nature of their interaction administered IV for postoperative pain after moderate painful surgery using up-and-down and isobolographic methods.
详细描述
Ninety patients scheduled to undergo moderately painful surgery were included in one of three groups. Determination of median effective (ED50) doses was performed by the Dixon and Mood up-and-down method. Initial doses were 1.5g and 5mg, with dose adjustment intervals of 0.5g and 1 mg, in the paracetamol and morphine groups, respectively. The initial doses of paracetamol and morphine were 1.5g and 3mg, respectively in the paracetamol-morphine combination group with dose adjustment intervals of 0.25g for paracetamol and 0.5mg for morphine. Analgesic efficacy was defined as a decrease to less than 3 on a 0-10 numeric pain scale, 45 min after the beginning of drug administration. Isobolographic analysis was used to define the nature of their interaction.
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
- Double (Investigator, Outcomes Assessor)
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
- •ASA physical status І or ІІ
- •Moderately painful surgery patients
- •postoperative pain more than 3 on a numerical pain score (NPS) -
排除标准
- •contraindication to the use of paracetamol and morphine
- •age younger than 18 yr
- •patient weight less 65kg
- •intra-operative regional anesthesia,
- •intra-operative administration of analgesics other than fentanyl,
- •postoperative pain less than 3 on a numerical pain score (NPS)
研究组 & 干预措施
Paracetamol
initial doses was 1.5g g, with dose adjustment intervals of 0.5g . with maximum dose 2.5 g as an only starting dose / 24 h
干预措施: Paracetamol (Drug)
Morphine
Initial doses of morphine was 5mg, with dose adjustment intervals of 1 mg .
干预措施: Morphine (Drug)
Paracetamol-morphine
The initial doses of paracetamol and morphine were 1.5g and 3mg, respectively in the paracetamol-morphine combination group with dose adjustment intervals of 0.25g for paracetamol and 0.5mg for morphine.
干预措施: Paracetamol- Morphine (Drug)
结局指标
主要结局
ED50s of Paracetamol, morphine and their combination
时间窗: participants will be followed for the duration of hospital stay, an expected average of 8 weeks
the aim of our study is to define the median effective analgesic doses (ED50s) of paracetamol, morphine, and their combination to determine the nature of their interaction administered IV for postoperative moderately painful surgery using the Dixon and Mood up-and-down method and isobolographic analysis.
次要结局
- Paracetamol-Morphine interaction nature(participants will be followed for the duration of hospital stay, an expected average of 8 weeks)
研究者
Ahed ZEIDAN
MD
Procare Riaya Hospital