Short-term Perfusion Effects: Dexketoprofen/Tramadol

NCT07386288 | Completed DMC

• 1 other identifier: 2024-16/01
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Renal Colic

Keywords

renal colic; emergency department; acute pain management; dexketoprofen trometamol; tramadol; tissue perfusion; end-tidal carbon dioxide

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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.

Drug: IV Tramadol + IV Dexketoprofen Trometamol

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.

Drug: Dexketoprofen Trometamol

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.

Drug: Tramadol

Interventions

Tramadol DRUG

Intravenous tramadol administered for analgesia in patients with renal colic.

IV Tramadol

Dexketoprofen Trometamol DRUG

Intravenous dexketoprofen trometamol administered for analgesia in patients with renal colic

IV Dexketoprofen Trometamol

IV Tramadol + IV Dexketoprofen Trometamol DRUG

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

IV Tramadol + IV Dexketoprofen

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University, Yakutiye Research Hospital

Yakutiye, Erzurum, 25240, Turkey (Türkiye)

Location

Related Publications (1)

• 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

  BACKGROUND

MeSH Terms

Conditions

Renal Colic; Emergencies

Interventions

Tramadol; dexketoprofen trometamol

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst Prof

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: February 4, 2026
• Study Start: November 1, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)