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

Ataturk University

Status: Completed

Conditions: Renal Colic

Treatments: Drug: Tramadol; Drug: Dexketoprofen Trometamol; Drug: IV Tramadol + IV Dexketoprofen Trometamol

Study type: Interventional

Funder types: Other

Identifiers

NCT07386288

2024-16/01

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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102 participants in 3 patient groups

IV Tramadol + IV Dexketoprofen

Experimental group

Description:

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.

Treatment:

Drug: IV Tramadol + IV Dexketoprofen Trometamol

IV Dexketoprofen Trometamol

Experimental group

Description:

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.

Treatment:

Drug: Dexketoprofen Trometamol

IV Tramadol

Experimental group

Description:

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.

Treatment:

Drug: Tramadol