Intravenous Paracetamol or Morphine for the Treatment of Acute Flank Pain : a Randomized, Double Blind, Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- Reduction in visual analogue scale
研究概览
简要总结
STUDY OBJECTIVE: This randomized, controlled trial evaluates the analgesic efficacy and safety of intravenous single-dose paracetamol and morphine for the treatment of acute flank pain.
METHODS: The investigators conducted a randomized, double-blind, controlled clinical trial comparing single intravenous doses of paracetamol (1 g) and morphine (0.1 mg/kg) for patients presenting to the emergency department (ED) with acute flank pain. Subjects with inadequate pain relief at 30 minutes received rescue fentanyl (0.75 microg/kg).
详细描述
Study Design and Setting:
This is a single-center, prospective, randomized, double-blind, clinical trial performed in an ED of a tertiary care hospital with annual census of approximately 37.000 visits. The local ethics committee approved the study.
Two treatment options, intravenous paracetamol and morphine, were compared for ceasing pain in patients presented with renal colic.
Selection of Participants:
Patients, aged 18 to 55 years, with flank pain were accepted as eligible for the study. Patients with clinical diagnosis of acute renal colic and declared to have moderate or serious pain according to the 4-point verbal scale were included into the study.
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, Care Provider)
入排标准
- 年龄范围
- 16 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (aged 16 to 55 years old) with acute low back pain were eligible for inclusion in the study
排除标准
- •known allergy or contraindication to morphine, paracetamol, or any opioid analgesic
- •hemodynamic instability; fever (temperature > 38°C [100.4°F])
- •evidence of peritoneal inflammation
- •documented or suspected pregnancy
- •known or suspected aortic dissection or aneurysm
- •use of any analgesic within 6 hours of ED presentation
- •previous study enrollment Patients with known renal, pulmonary, cardiac, or hepatic failure, as well as those with renal transplantation, were also excluded.
研究组 & 干预措施
Paracetamol
干预措施: Paracetamol (Drug)
Paracetamol
干预措施: Morphine (Drug)
Morphine
干预措施: Paracetamol (Drug)
Morphine
干预措施: Morphine (Drug)
结局指标
主要结局
Reduction in visual analogue scale
时间窗: 15 minutes interval
The pain of the study subjects was measured after 15th and 30th minutes later after the study drug administered.
次要结局
- Adverse events.(30th minutes after)