Paracetamol-Tramadol and Paracetamol-caffeine Versus Placebo in the Emergency Discharge Treatment of Renal Colic
- Conditions
- Renal Colic
- Interventions
- Registration Number
- NCT06345716
- Lead Sponsor
- University of Monastir
- Brief 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)
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1500
- -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).
- -Inability to appreciate pain according to the VAS.
- Pregnant or breastfeeding woman.
- Renal insufficiency with creatinine clearance < 60 ml/min.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Paracétamol-tramadol paracétamol tramadol Each patient received 1 tablet \* 2/day synalvic (325 mg of paracetamol + 37.5 mg of tramadol) for 7 days. Paracetamol-caffeine Paracétamol cafeine Each patient received 1 tab \* 3/d stopalgic extra (65mgcaffeine+500mg paracetamol) for 7 days Placebo Placebo 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.
- Primary Outcome Measures
Name Time Method Recurrence of RC and ED readmission 7 day after inclusion included recurrence of RC and ED readmission within 7-day follow-up
- Secondary Outcome Measures
Name Time Method mean time interval 7 day after inclusion mean time to recurrence of pain
side effects 7 days 30 days occurence of side effects
Trial Locations
- Locations (1)
Semir Nouira
🇹🇳Monastir, Tunisia