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Short-term Perfusion Effects: Dexketoprofen/Tramadol

NCT07386288 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2026-02-04

No results posted yet for this study

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

Interventions

DRUG

Tramadol

Intravenous tramadol administered for analgesia in patients with renal colic.

DRUG

Dexketoprofen Trometamol

Intravenous dexketoprofen trometamol administered for analgesia in patients with renal colic

DRUG

IV Tramadol + IV Dexketoprofen Trometamol

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

Sponsors & Collaborators

  • Ataturk University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2025-04-30
Completion
2025-04-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07386288 on ClinicalTrials.gov