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Renal ColicDeXTra-RCNCT07386288

Short-term Perfusion Effects: Dexketoprofen/Tramadol

A study testing Tramadol, Dexketoprofen Trometamol and IV Tramadol + IV Dexketoprofen Trometamol in people with Renal Colic, run by Ataturk University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Renal Colic
What is being tested?
Tramadol, Dexketoprofen Trometamol and IV Tramadol + IV Dexketoprofen Trometamol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Nov 2024to 30 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Ataturk University, Yakutiye Research Hospital

    Yakutiye, Erzurum, 25240

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Conditions
Renal Colic
Being tested
Tramadol, Dexketoprofen Trometamol, IV Tramadol + IV Dexketoprofen Trometamol
Keywords
renal colic, emergency department, acute pain management, dexketoprofen trometamol, tramadol, tissue perfusion, end-tidal carbon dioxide
Medical subject headings
Renal Colic, Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TramadolDrug

    Intravenous tramadol administered for analgesia in patients with renal colic.

  • Dexketoprofen TrometamolDrug

    Intravenous dexketoprofen trometamol administered for analgesia in patients with renal colic

  • IV Tramadol + IV Dexketoprofen TrometamolDrug

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

Study groups in NCT07386288
Study groupRoleWhat they receive
IV Tramadol + IV DexketoprofenExperimentalParticipants 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.
Receives: Drug: IV Tramadol + IV Dexketoprofen Trometamol
IV Dexketoprofen TrometamolExperimentalParticipants 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.
Receives: Drug: Dexketoprofen Trometamol
IV TramadolExperimentalParticipants 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.
Receives: Drug: Tramadol

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 0, 30, and 60 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2026
  2. Study start1 Nov 2024
  3. Primary completion30 Apr 2025
  4. Study completion30 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07386288
Sponsor's protocol ID
2024-16/01
Acronym
DeXTra-RC
Status last verified
Jan 2026
First submitted
20 Jan 2026
Last updated
4 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

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

Questions about this trial

What is this clinical trial studying?

A study testing Tramadol, Dexketoprofen Trometamol and IV Tramadol + IV Dexketoprofen Trometamol in people with Renal Colic, run by Ataturk University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in End-Tidal Carbon Dioxide (EtCO₂) (time frame: 0, 30, and 60 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07386288, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.

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Short-term Perfusion Effects: Dexketoprofen/Tramadol | AzTrials