About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
-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).
Disqualifiers
-Inability to appreciate pain according to the VAS.
Pregnant or breastfeeding woman.
Renal insufficiency with creatinine clearance < 60 ml/min.
Trial design
Parallel
Treatments tested in this trial
paracétamol tramadol
DrugEach patient received 1 tablet \* 2/day synalvic (325 mg of paracetamol + 37.5 mg of tramadol) for 7 days
Paracétamol cafeine
DrugEach patient received 1 tab \* 3/d stopalgic extra (65mgcaffeine+500mg paracetamol) for 7 days
Placebo
DrugEach patient received 1 tab \* 3 / d of placebo (flour) every day for 7 days
Treatment groups
Trial outcomes
Primary outcomes
Recurrence of RC and ED readmission
included recurrence of RC and ED readmission within 7-day follow-up
Secondary outcomes
mean time interval
mean time to recurrence of pain
side effects
occurence of side effects
Other outcomes
Adverse effects
-Adverse effects of treatment and its tolerance.
Sponsors and contacts
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