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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paracétamol-tramadol | Experimental | Each patient received 1 tablet * 2/day synalvic (325 mg of paracetamol + 37.5 mg of tramadol) for 7 days. |
|
| Paracetamol-caffeine | Experimental | Each patient received 1 tab * 3/d stopalgic extra (65mgcaffeine+500mg paracetamol) for 7 days |
|
| Placebo | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paracétamol tramadol | Drug | Each patient received 1 tablet * 2/day synalvic (325 mg of paracetamol + 37.5 mg of tramadol) for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of RC and ED readmission | included recurrence of RC and ED readmission within 7-day follow-up | 7 day after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| mean time interval | mean time to recurrence of pain | 7 day after inclusion |
| side effects | occurence of side effects | 7 days 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse effects | -Adverse effects of treatment and its tolerance. | 7 days 30 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Khaoula Bel Haj Ali | Contact | 99792724 | belhajalikhaoula@yahoo.fr | |
| Semir Nouira, Pr | Contact | 21673106046 |
| Name | Affiliation | Role |
|---|---|---|
| Khaoula Bel Haj Ali | CHU Fattouma Bourguiba Monastir, service des urgences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Semir Nouira | Recruiting | Monastir | Tunisia |
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| ID | Term |
|---|---|
| D056844 | Renal Colic |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Paracétamol cafeine | Drug | Each patient received 1 tab * 3/d stopalgic extra (65mgcaffeine+500mg paracetamol) for 7 days |
|
|
| Placebo | Drug | Each patient received 1 tab * 3 / d of placebo (flour) every day for 7 days |
|
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