Short-term Perfusion Effects: Dexketoprofen/Tramadol

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07386288

Acronym

DeXTra-RC

Enrollment

102

Registered

2026-02-04

Start date

2024-11-01

Completion date

2025-04-30

Last updated

2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Colic

Keywords

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

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.

Interventions

DRUGTramadol

Intravenous tramadol administered for analgesia in patients with renal colic.

DRUGDexketoprofen Trometamol

Intravenous dexketoprofen trometamol administered for analgesia in patients with renal colic

DRUGIV Tramadol + IV Dexketoprofen Trometamol

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026