CompletedNot Applicable

Short-term Perfusion Effects: Dexketoprofen/Tramadol

Turkey (Türkiye)102 participantsStarted 2024-11-01

Plain-language 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.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in End-Tidal Carbon Dioxide (EtCO₂)

Timeframe: 0, 30, and 60 minutes

Trial details

NCT IDNCT07386288

SponsorAtaturk University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-30

View on ClinicalTrials.gov More Renal Colic trials