Short-term Perfusion Effects: Dexketoprofen/Tramadol (DeXTra-RC)

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

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.

Study Overview

• Status: Completed
• Conditions: Renal Colic
• Intervention / Treatment: Drug: IV Tramadol + IV Dexketoprofen Trometamol; Drug: Dexketoprofen Trometamol; Drug: Tramadol

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Erzurum
    • Yakutiye, Erzurum, Turkey (Türkiye), 25240
      • Ataturk University, Yakutiye Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: IV Tramadol + IV Dexketoprofen Trometamol; Intravenous dexketoprofen trometamol and tramadol administered for analgesia in patients with renal colic
Experimental: 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.	Drug: Dexketoprofen Trometamol; Intravenous dexketoprofen trometamol administered for analgesia in patients with renal colic
Experimental: 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.	Drug: Tramadol; Intravenous tramadol administered for analgesia in patients with renal colic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in End-Tidal Carbon Dioxide (EtCO₂)	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.	0, 30, and 60 minutes

Collaborators and Investigators

• Sponsor: Ataturk University

Publications and helpful links

General Publications

• 1. Patti L, Leslie SW. Acute Renal Colic. StatPearls. Treasure Island (FL)2025. 2. Golzari SE, Soleimanpour H, Rahmani F, Zamani Mehr N, Safari S, Heshmat Y, et al. Therapeutic approaches for renal colic in the emergency department: a review article. Anesth Pain Med. 2014;4(1):e16222. https://doi.org/10.5812/aapm.16222 3. Skolarikos A, Geraghty R, Somani B, Tailly T, Jung H, Neisius A, et al. European Association of Urology Guidelines on the Diagnosis and Treatment of Urolithiasis. Eur Urol. 2025;88(1):64-75. https://doi.org/10.1016/j.eururo.2025.03.011 4. Broder JS, Oliveira JESL, Bellolio F, Freiermuth CE, Griffey RT, Hooker E, et al. Guidelines for Reasonable and Appropriate Care in the Emergency Department 2 (GRACE-2): Low-risk, recurrent abdominal pain in the emergency department. Acad Emerg Med. 2022;29(5):526-60. https://doi.org/10.1111/acem.14495 5. Morgan S. Intravenous paracetamol in patients with renal colic. Emerg Nurse. 2011;18(9):22-5. https://doi.org/10.7748/en2011.02.18.9.22.c8337 6. Holdgate A, Pollock T. Nonsteroidal anti-inflammatory drugs (NSAIDs) versus opioids for acute renal colic. Cochrane Database Syst Rev. 2004(1):CD004137. https://doi.org/10.1002/14651858.CD004137.pub2 7. Pathan SA, Mitra B, Cameron PA. A Systematic Review and Meta-analysis Comparing the Efficacy of Nonsteroidal Anti-inflammatory Drugs, Opioids, and Paracetamol in the Treatment of Acute Renal Colic. Eur Urol. 2018;73(4):583-95. https://doi.org/10.1016/j.eururo.2017.11.001 8. Cabo JJS, Miller NL. Nonopioid Pain Management Pathways for Stone Disease. J Endourol. 2024;38(2):108-20. https://doi.org/10.1089/end.2023.0266 9. Fu S, Zhang K, Gu M, Liu Z, Sun W, Xiao M. Comparative efficacy and safety of analgesics for acute renal colic: A network meta-analysis protocol. Medicine (Baltimore). 2019;98(10):e14709. https://doi.org/10.1097/MD.0000000000014709 10. Özdemir M, Çığşar Gl, Bağcıoğlu M, Çiftçi H, Günal E. Comparison of the Analgesic Effects of Intravenous Dexketoprofen, Ib

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Actual): April 30, 2025
• Study Completion (Actual): April 30, 2025

Study Registration Dates

• First Submitted: January 20, 2026
• First Submitted That Met QC Criteria: January 27, 2026
• First Posted (Actual): February 4, 2026

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: emergency department; tramadol; renal colic; end-tidal carbon dioxide; dexketoprofen trometamol; tissue perfusion; acute pain management
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergencies; Renal Colic; Organic Chemicals; Lipids; Amines; Alcohols; Cyclohexanols; Hexanols; Fatty Alcohols; Dimethylamines; Methylamines; Tramadol; dexketoprofen trometamol
• Other Study ID Numbers: 2024-16/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data that support the findings of this study are not publicly available due to privacy and ethical restrictions, as they contain identifiable patient information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No