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Search / Trial NCT06345716

Paracetamol-Tramadol and Paracetamol-caffeine Versus Placebo in the Emergency Discharge Treatment of Renal Colic

Launched by UNIVERSITY OF MONASTIR · Apr 1, 2024

Trial Information

Current as of May 06, 2025

Recruiting

Keywords

Renal Colic Paracetamol Tramadol Paracetamol Cafeine Placebo

ClinConnect Summary

This clinical trial is exploring the effectiveness of two different pain relief combinations—paracetamol with tramadol and paracetamol with caffeine—compared to a placebo (a treatment that has no active ingredients) for patients being discharged after experiencing renal colic, which is severe pain caused by kidney stones. The goal is to see which treatment best helps manage pain once patients leave the hospital.

To participate in this study, individuals must be over 18 years old, have experienced sudden flank or lower back pain that has been diagnosed as renal colic, and have a pain score of less than 30 when they are discharged. Pregnant or breastfeeding women, as well as those with certain kidney conditions, cannot participate. If eligible, participants will be randomly assigned to one of the three groups and will receive their assigned treatment upon leaving the emergency department. This trial is currently recruiting participants and aims to improve pain management options for future patients.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • -Age \> 18 years old.
  • Consent to participate in the study.
  • Pain in the flank/lumbar fossa of sudden onset with urine strips and/or imaging corresponding to the diagnosis of renal colic.
  • Pain score at discharge \< 30 (visual analog scale - VAS or verbal numerical scale - VAS from 0 to 100).
  • Exclusion Criteria:
  • -Inability to appreciate pain according to the VAS.
  • Pregnant or breastfeeding woman.
  • Renal insufficiency with creatinine clearance \< 60 ml/min.

About University Of Monastir

The University of Monastir, a prominent educational and research institution in Tunisia, is dedicated to advancing medical and clinical research through its innovative programs and collaborations. With a strong emphasis on improving healthcare outcomes, the university actively sponsors clinical trials that explore new therapeutic approaches and enhance patient care. Leveraging its state-of-the-art facilities and a diverse team of experienced researchers and clinicians, the University of Monastir aims to contribute significantly to the global body of medical knowledge while fostering a culture of scientific inquiry and excellence.

Locations

Monastir, , Tunisia

Patients applied

0 patients applied

Trial Officials

Khaoula Bel Haj Ali

Study Director

CHU Fattouma Bourguiba Monastir, service des urgences

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported