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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Monastir, , Tunisia
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