Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 (EtCOâ‚‚) 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 (SpOâ‚‚) and EtCOâ‚‚ 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 EtCOâ‚‚ over time.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tramadol | Drug | Intravenous tramadol administered for analgesia in patients with renal colic. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in End-Tidal Carbon Dioxide (EtCOâ‚‚) | End-tidal carbon dioxide (EtCOâ‚‚) 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 EtCOâ‚‚. | 0, 30, and 60 minutes |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ataturk University, Yakutiye Research Hospital | Yakutiye | Erzurum | 25240 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 7, 2024 | Jan 20, 2026 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D056844 | Renal Colic |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D014147 | Tramadol |
| C118296 | dexketoprofen trometamol |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Dexketoprofen Trometamol | Drug | Intravenous dexketoprofen trometamol administered for analgesia in patients with renal colic |
|
| IV Tramadol + IV Dexketoprofen Trometamol | Drug | Intravenous dexketoprofen trometamol and tramadol administered for analgesia in patients with renal colic |
|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |