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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,500
Each patient received 1 tablet \* 2/day synalvic (325 mg of paracetamol + 37.5 mg of tramadol) for 7 days
Each patient received 1 tab \* 3/d stopalgic extra (65mgcaffeine+500mg paracetamol) for 7 days
Each patient received 1 tab \* 3 / d of placebo (flour) every day for 7 days
Semir Nouira
Monastir, Tunisia
RECRUITINGRecurrence 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
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