Renal Colic
Conditions
Keywords
renal colic, paracetamol-tramadol, paracetamol-cafeine, placebo
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)
Interventions
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
Sponsors
Study design
Eligibility
Inclusion criteria
* -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).
Exclusion criteria
* -Inability to appreciate pain according to the VAS. * Pregnant or breastfeeding woman. * Renal insufficiency with creatinine clearance \< 60 ml/min.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of RC and ED readmission | 7 day after inclusion | included recurrence of RC and ED readmission within 7-day follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mean time interval | 7 day after inclusion | mean time to recurrence of pain |
| side effects | 7 days 30 days | occurence of side effects |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse effects | 7 days 30 days | -Adverse effects of treatment and its tolerance. |
Countries
Tunisia