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OpenTrials
Completed

NCT Number: NCT07386288

Short-term Perfusion Effects: Dexketoprofen/Tramadol

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ataturk University, Yakutiye Research Hospital

Yakutiye, Erzurum, 25240, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A Glasgow Coma Scale score of 15
  • Spontaneous respiration
  • The capacity to provide informed consent

Exclusion criteria

  • 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.

Treatment and study plan

Tramadol

Drug

Intravenous tramadol administered for analgesia in patients with renal colic.

dexketoprofen trometamol

Drug

Intravenous dexketoprofen trometamol administered for analgesia in patients with renal colic

IV Tramadol + IV Dexketoprofen Trometamol

Drug

Intravenous dexketoprofen trometamol and tramadol administered for analgesia in patients with renal colic

Primary outcomes

  1. Change in End-Tidal Carbon Dioxide (EtCO₂)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

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

Acronym: DeXTra-RC

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 4, 2026
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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