Short-term Effects of Intravenous Dexketoprofen Trometamol and Tramadol on Perfusion-Related Physiological Parameters in Renal Colic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Change in End-Tidal Carbon Dioxide (EtCO₂)
研究概览
简要总结
Background: Acute renal colic is a common reason for admission to the emergency department (ED) and is associated with severe pain, sympathetic activation and metabolic stress. Non-steroidal anti-inflammatory drugs (NSAIDs) and opioids are widely used for analgesia, but their short-term effects on tissue perfusion and respiratory physiology in stable patients are unclear. End-tidal carbon dioxide (EtCO₂) has been suggested as a non-invasive indicator of overall tissue perfusion, but how it behaves during analgesic treatment in stable ED patients is unclear.
Methods: This prospective, randomised study was conducted in an academic emergency department. Adult patients (aged 18-55) presenting with acute renal colic were randomised to receive an intravenous infusion of either dexketoprofen trometamol (50 mg), tramadol (100 mg), or a combination of dexketoprofen trometamol (50 mg) and tramadol (50 mg). Vital signs, oxygen saturation (SpO₂) and EtCO₂ were recorded at baseline and at 30 and 60 minutes. Arterial blood gas parameters, including lactate, were measured at baseline and after 60 minutes. The primary outcome was the change in EtCO₂ over time.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A Glasgow Coma Scale score of 15
- •Spontaneous respiration
- •The capacity to provide informed consent
排除标准
- •Pregnancy or breastfeeding
- •Chronic kidney disease,
- •Known allergy to study medications,
- •Chronic respiratory disease,
- •Hemodynamic instability,
- •Acute intoxication,
- •Uncontrolled epilepsy,
- •Recent monoamine oxidase inhibitor use.
研究组 & 干预措施
IV Tramadol + IV Dexketoprofen
Participants receive intravenous tramadol plus intravenous dexketoprofen trometamol for acute pain management due to renal colic. Perfusion-related physiological parameters are measured before and after administration.
干预措施: IV Tramadol + IV Dexketoprofen Trometamol (Drug)
IV Dexketoprofen Trometamol
Participants with renal colic receive intravenous dexketoprofen trometamol for analgesia. Perfusion-related physiological parameters are recorded at baseline and at predefined time points after administration to assess short-term effects.
干预措施: Dexketoprofen Trometamol (Drug)
IV Tramadol
Participants with renal colic receive intravenous tramadol for analgesia. Perfusion-related physiological parameters are recorded at baseline and at predefined time points after administration to assess short-term effects.
干预措施: Tramadol (Drug)
结局指标
主要结局
Change in End-Tidal Carbon Dioxide (EtCO₂)
时间窗: 0, 30, and 60 minutes
End-tidal carbon dioxide (EtCO₂) will be measured using capnography at baseline and at predefined time points following intravenous administration of tramadol and/or dexketoprofen trometamol in patients with renal colic. The primary endpoint is the change from baseline in EtCO₂.
次要结局
未报告次要终点
