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临床试验/NCT07386288
NCT07386288已完成不适用

Short-term Effects of Intravenous Dexketoprofen Trometamol and Tramadol on Perfusion-Related Physiological Parameters in Renal Colic

Ataturk University1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2024年11月1日最近更新:
干预措施

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

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

Experimental

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

Experimental

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

Experimental

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mevlana GÜL

Asst Prof

Ataturk University

研究点 (1)

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