Clinical Trial

Short-term Perfusion Effects: Dexketoprofen/Tramadol

Study acronym: DeXTra-RC
Completed
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Summary
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.
Trial Details
NCT Number NCT07386288
Lead Sponsor Ataturk University
Conditions Renal Colic
Enrollment 102 participants
Start Date 2024-11-01
Primary Completion 2025-04-30 (estimated)
Study Completion 2025-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-02-04