The Efficacy of Intravenous Paracetamol Versus Dipyrone for Postoperative Analgesia After Day-case Lower Abdominal Surgery in Children With Spinal Anesthesia: a Prospective Randomized Double-blind Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 2
- 主要终点
- Change from pain intensity until postoperative 6 hours
研究概览
简要总结
We conducted a prospective, randomized double-blind study to compare the effectiveness of intravenous paracetamol and dipyrone for preventing pain during early postoperative period in school-age children undergoing lower abdominal surgery with spinal anesthesia.
详细描述
The intensity of postoperative pain was assessed using a visual analog scale (VAS) (0 represented no pain and 10 the worst pain ever experienced) at 15, 30, 60th minutes, and 2nd, 4th, 6th hours postoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 8 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesiologist (ASA) physical status I and II children undergoing elective lower abdominal surgery
排除标准
- •increased intracranial pressure hemorrhagic diathesis infection at the puncture site Those with a known history of allergy to the study drugs
研究组 & 干预措施
Paracetamol
15 mg/kg paracetamol, IV (in the vein)(premixed with 0.9% sodium chloride to a total of 50 ml)single dose
干预措施: Paracetamol (Drug)
Dipyrone
15 mg/kg IV (in the vein)dipyrone received (premixed with 0.9% sodium chloride to a total of 50 ml), single dose
干预措施: Dipyrone (Drug)
结局指标
主要结局
Change from pain intensity until postoperative 6 hours
时间窗: Pain intensity recorded until postoperative 6 hours
The intensity of postoperative pain was assessed using a visual analog scale (VAS) (0 represented no pain and 10 the worst pain ever experienced) at 15, 30, 60th minutes, and 2nd, 4th, 6th hours postoperatively.
次要结局
未报告次要终点
研究者
Esra Caliskan
Associated Professor
Baskent University