NCT06345716

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,500 (estimated)
• Sponsor: University of Monastir · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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)

Conditions

• Renal Colic

Interventions

Type	Name	Description
DRUG	paracétamol tramadol	Each patient received 1 tablet \* 2/day synalvic (325 mg of paracetamol + 37.5 mg of tramadol) for 7 days
DRUG	Paracétamol cafeine	Each patient received 1 tab \* 3/d stopalgic extra (65mgcaffeine+500mg paracetamol) for 7 days
DRUG	Placebo	Each patient received 1 tab \* 3 / d of placebo (flour) every day for 7 days

Timeline

• Start date: 2024-04-10
• Primary completion: 2025-03-15
• Completion: 2025-11-30
• First posted: 2024-04-03
• Last updated: 2024-09-19

Locations

1 site across 1 country: Tunisia