Study Comparing Paracetamol-Tramadol and Paracetamol-Caffeine to Placebo for Pain Relief After Emergency Treatment of Renal Colic

What this Trial Is About

The trial investigates treatments for patients who have experienced an acute attack of renal colic and have been successfully treated in the Emergency Department. It is a prospective, randomized, single-blind study comparing the effects of oral paracetamol combined with tramadol, oral paracetamol combined with caffeine, and a placebo. The goal is to evaluate these treatments during the emergency discharge phase for renal colic patients. Participants are randomly assigned to one of three groups upon discharge one group receives two tablets daily of paracetamol-tramadol 325 mg paracetamol 37.5 mg tramadol for 7 days, another group takes three tablets daily of paracetamol-caffeine 65 mg caffeine 500 mg paracetamol for 7 days, and the last group receives three placebo tablets daily for 7 days. All tablets are identically packaged to maintain blinding. Throughout the study, data such as temperature, blood pressure, heart rate, pain intensity measured by visual analog scale, abdominal tenderness, and specific signs related to renal colic are collected. Additional tests like ultrasound, urine culture, renal ultrasound, creatinine levels, and blood sugar are performed based on clinical context. Researchers monitor recurrence of renal colic and emergency department readmissions within 7 days after inclusion, along with side effects up to 30 days. The total participation duration includes the 7-day treatment and follow-up assessments.

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