Parecoxib vs Paracetamol in the Treatment of Acute Renal Colic Due to Ureteric Calculi: Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The need for rescue analgesia (Morphine)
研究概览
简要总结
This study will be conducted to compare the efficacy and safety of Parecoxib versus Paracetamol for treatment of acute renal colic due to ureteric stones.
详细描述
Eligible patients will be randomized to one of the two treatment groups. Group 1 patients will receive IV 1 g of Paracetamol while group 2 patients will receive 40 mg of Parecoxib IV.
The Visual Analogue Scale (VAS) will be calculated on presentation and at 30 minutes after analgesia administration. Patients who do not respond to an initial dose of the analgesia will receive rescue analgesia in the form of Morphine, 01.mg/kg, IV.
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 (Participant, Investigator)
盲法说明
The emergency department (ED) nurse will do randomization by drawing one of the sealed closed envelopes that contain the analgesic to be administered.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical signs and symptoms consistent with acute renal colic
排除标准
- •Hypersensitivity to either Paracetamol or Parecoxib.
- •History of peptic ulcer.
- •Pregnant or breastfeeding females.
- •Patients with hepatic impairment (Child-Pugh score >10).
- •Patients with chronic kidney disease (CKD) Stage 4 or 5 (eGFR <30mls/min).
- •History of coronary ischemia, peripheral vascular or cerebrovascular disease.
研究组 & 干预措施
Paracetamol
Patients will receive IV 1 g of Paracetamol
干预措施: Paracetamol (Drug)
Parecoxib
Patients will receive 40 mg of Parecoxib IV
干预措施: Parecoxib (Drug)
结局指标
主要结局
The need for rescue analgesia (Morphine)
时间窗: 30 minutes
Patient who had persistent pain
次要结局
- The incidence of adverse effects due to medication used(24 hours)
研究者
Ahmed R. EL-Nahas
Professor of Urology
Mansoura University