A Phase 2 interventional study of paracétamol tramadol and Paracétamol cafeine in Renal Colic, sponsored by University of Monastir. Recruiting at 1 site in Tunisia. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University of Monastir · Phase 2, Interventional, and Treatment
This is a prospective, randomized, single-blind study. Patients included in the study after successful treatment of the acute attack were randomized upon discharge from the Emergency Department into three groups: oral paracetamol-tramadol group, oral paracetamol-caffeine group and oral placebo group.
This is a prospective, randomized, single-blind study. Patients included in the study after successful treatment of the acute attack were randomized upon discharge from the Emergency Department into three groups: oral paracetamol-tramadol group, oral paracetamol-caffeine group and oral placebo group.
Different parameters are collected on a standard form prepared for all cases of renal colic included in our study. This sheet essentially contains:
Temperature, systolic and diastolic blood pressure, heart rate, pain intensity assessed by VAS, abdominal tenderness as well as the existence of Giardano signs.
Additional examinations were not systematically carried out for all patients: AUSP, ECBU, renal ultrasound, creatinemia and blood sugar. Their realization depended on the clinical context.
The use of imaging was done following the indications specified in the text of the consensus of the French Society of Emergency Medicine (updated in 2008)
79 studies on the registry are indexed under Renal Colic; 10 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 118 across 60 interventional studies indexed under Renal Colic.
Browse Renal Colic studies →University of Monastir is the lead sponsor of 114 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Each patient received 1 tablet \* 2/day synalvic (325 mg of paracetamol + 37.5 mg of tramadol) for 7 days.
Drug: paracétamol tramadol
Each patient received 1 tab \* 3/d stopalgic extra (65mgcaffeine+500mg paracetamol) for 7 days
Drug: Paracétamol cafeine
Each patient received 1 tab \* 3 / d of placebo (flour) every day for 7 days. \*For the three groups, the tablets were packaged hermetically in identical envelopes taken at random to respect double blinding.
Drug: Placebo
Each patient received 1 tablet \* 2/day synalvic (325 mg of paracetamol + 37.5 mg of tramadol) for 7 days
Also known as: B
Each patient received 1 tab \* 3/d stopalgic extra (65mgcaffeine+500mg paracetamol) for 7 days
Also known as: A
Each patient received 1 tab \* 3 / d of placebo (flour) every day for 7 days
Also known as: C
Recurrence of RC and ED readmission
included recurrence of RC and ED readmission within 7-day follow-up
Time frame: 7 day after inclusion
mean time interval
mean time to recurrence of pain
Time frame: 7 day after inclusion
side effects
occurence of side effects
Time frame: 7 days 30 days
Adverse effects
-Adverse effects of treatment and its tolerance.
Time frame: 7 days 30 days
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2024 (actual). Primary completion is estimated for Mar 2025, 11 months after the start.
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