NCT00292214已完成4 期
Comparative Pharmacokinetics of Intravenous and Oral Paracetamol in the Peri-Operative Period of Laparoscopic Cholecystectomy
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Early pharmacokinetics (0-240 minutes) of a single dose of 1g paracetamol in IV and oral formulations
研究概览
简要总结
To determine the amount of paracetamol in the blood when given in either intravenous or oral forms prior to cholecystectomy. The clinical effectiveness of each form will also be evaluated with pain scores and the use of other pain relief drugs.
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
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged 18-75
- •Scheduled to have elective laparoscopic cholecystectomy under general anaesthesia
排除标准
- •Inadequate English comprehension (difficult to obtain informed consent and cooperation), and when interpreters are not available.
- •History of allergy or sensitivity to paracetamol
- •Administration of oral paracetamol within previous 8 hours
- •American Society of Anesthesiologists (ASA) grade IV or V, indicating serious cardio-respiratory co-morbidity
- •Not suitable for protocol anaesthetic technique (eg: history of nausea and vomiting with morphine)
结局指标
主要结局
Early pharmacokinetics (0-240 minutes) of a single dose of 1g paracetamol in IV and oral formulations
次要结局
- Difference in analgesia achieved (15-120 minutes post-operative) with IV and oral paracetamol.
研究者
研究点 (2)
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