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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002381-23 | EudraCT Number |
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same study already published
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The main objective of this study was to demonstrate the non-inferiority of intravenous paracetamol relative to intravenous ketoprofen when treating renal colic in an emergency ward. Efficacy is measured by the change in verbal numeric scale (vns) for pain at 30 minutes.
The secondary objectives of this study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketaprofen | Active Comparator | Patients randomized to this arm will receive intravenous ketaprofen when treating renal colic. Intervention: intravenous ketaprofen |
|
| Paracetamol | Experimental | Patients randomized to this arm will receive intravenous paracetamol when treating renal colic. Intervention: intravenous paracetamol |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous ketoprofen | Drug | Patients will recieve 100 mg of ketoprofen via slow intravenous perfusion. (100mg of ketoprofen powder for injection dissolved in 100 ml injectable isotonic solution) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in vns for pain | Verbal numeric scale ranging from 0 to 10.0. | baseline to 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Change in vns for pain | Verbal numeric scale ranging from 0 to 10.0. | baseline to 90 minutes |
| Quantity of (posology) tramadol administered | baseline (minute 0) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre-GĂ©raud Claret, MD | Centre Hospitalier Universitaire de NÄ«mes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH d'Alès | Alès | 30103 | France | |||
| CHU de Nîmes - Hôpital Universitaire Carémeau |
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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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| Intravenous paracetamol | Drug | Patients will receive 1g of paracetamol via slow intravenous perfusion. (100 ml of solution at 10mg/ml) |
|
| Quantity of (posology) tramadol administered | 30 minutes |
| Quantity of (posology) tramadol administered | 90 minutes |
| Quantity of (posology) tramadol administered | discharge from emergency ward (estimated max of 24 hours) |
| Quantity of (posology) phloroglucinol administered | baseline (minute 0) |
| Quantity of (posology) phloroglucinol administered | 30 minutes |
| Quantity of (posology) phloroglucinol administered | 90 minutes |
| Quantity of (posology) phloroglucinol administered | discharge from emergency ward (estimated max of 24 hours) |
| Was morphine administered? yes/no | baseline (minute 0) |
| Quantity of (posology) morphine administered | 30 minutes |
| Quantity of (posology) morphine administered | 90 minutes |
| Quantity of (posology) morphine administered | discharge from emergency ward (estimated max of 24 hours) |
| Quantity of (posology) Nefopam administered | baseline (minute 0) |
| Quantity of (posology) Nefopam administered | 30 minutes |
| Quantity of (posology) Nefopam administered | 90 minutes |
| Quantity of (posology) Nefopam administered | discharge from emergency ward (estimated max of 24 hours) |
| Quantity of (posology) Alfuzosine administered | baseline (minute 0) |
| Quantity of (posology) Alfuzosine administered | 30 minutes |
| Quantity of (posology) Alfuzosine administered | 90 minutes |
| Quantity of (posology) Alfuzosine administered | discharge from emergency ward (estimated max of 24 hours) |
| Presence/absence of complications | cutaneous manifestation, edema, bronchospasm, nausea, vomiting, headache, palpitation, chest pain, dizziness, disturbance of consciousness, dyspnea, acute retention of urine | baseline (minute 0) |
| Presence/absence of complications | cutaneous manifestation, edema, bronchospasm, nausea, vomiting, headache, palpitation, chest pain, dizziness, disturbance of consciousness, dyspnea, acute retention of urine | 30 minutes |
| Presence/absence of complications | cutaneous manifestation, edema, bronchospasm, nausea, vomiting, headache, palpitation, chest pain, dizziness, disturbance of consciousness, dyspnea, acute retention of urine | 90 minutes |
| Presence/absence of complications | cutaneous manifestation, edema, bronchospasm, nausea, vomiting, headache, palpitation, chest pain, dizziness, disturbance of consciousness, dyspnea, acute retention of urine | week 1 |
| Was the patient hospitalized? yes/no | discharge from emergency ward (estimated max of 24 hours) |
| Was the patient hospitalized? yes/no | week 1 |
| VNS for patient satisfaction concerning care | week 1 |
| Evolution towards a complicated renal colic | Qualitative variable with the following classes: obstructive pyelonephritis, hyperalgesia, urinary tract rupture, need for surgical drainage, sepsis, death | discharge from emergency ward (estimated max of 24 hours) |
| Evolution towards a complicated renal colic | Qualitative variable with the following classes: obstructive pyelonephritis, hyperalgesia, urinary tract rupture, need for surgical drainage, sepsis, death | week 1 |
| Nîmes |
| 30029 |
| France |