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Outpatients treatment with NSAI in renal colics has not been well investigated and there is no clear recommendations regarding this matter.
The aim of this study is to determine if an oral NSAI treatment is beneficial in patients discharged for the emergency departement after the first line treatment of a renal colic investigating the recurrence of pain, the reconsultation rates and the admissions.
Renal colic (RC)are a frequent cause of consultation in the emergency departement (ED).
They count for approximatively 20% of patients presenting to the ED with severe acute onset abdominal pain.
The first line treatment of renal colics is based on NSAI drugs associated with antalgics and is further investigated in the NSAI vs Morphine study (NCT02156596).
But there is no clear recommendations regarding the outpatient treatment of renal colics.
Oral NSAI are still widely used as a second line medicine for this condition and variety of molecules were tried with no solid scientific arguments.
Piroxicam, a non-selective COX inhibitor drug appared to the Oxicam class of NSAI, is widely used to treat rheumatoid conditions and other inflammatory conditions and often prescribed in Tunisia as a second line treatment of RC.
In this study, we aimed to investigate the efficiency and safety of the use of oral NSAI drugs (Piroxicam) compared to paracetamol or placebo as a second line treatment of renal colics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Piroxicam | Active Comparator | Piroxicam : 20 mg per pill; one pill per day for five days associated with placebo (1pill) (taken separately) |
|
| Placebo | Placebo Comparator | Placebo: two pills per day for five days (taken separately) |
|
| paracetamol | Active Comparator | paracetamol: 2000mg per day for five days two pills taken separately) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Piroxicam | Drug | Patients allocated to this arm received, as a second line treatment of renal colics, a five days treatment with 20 mg piroxicam associated with placebo per day and were contacted at the seventh day by telephone call to investigate the efficacity and the side effects of the treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacity of oral NSAI (telephone call, asking for the recurrence of pain, the reconsultation rates and intervals and the need for other treatments) | The efficacity of the oral NSAI treatment was evaluated at the seventh day by a telephone call, asking for the recurrence of painand the readmission rates) | seven days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of NSAI (telephone call, asking for mean time to recurrence and the occurence of NSAI side effects such as abdominal pain, vomiting, rush, bleeding and ect) | The efficacity of the oral NSAI treatment was evaluated at the seventh day by a telephone call, asking for the occurence of NSAI side effects such as abdominal pain, vomiting, rush, bleeding and ect | seven days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Semir Nouira, MD | University of Monastir | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emergency Department of University Hospital of Monastir | Monastir | 5050 | Tunisia |
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| Label | URL |
|---|---|
| official department site | View source |
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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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| ID | Term |
|---|---|
| D010894 | Piroxicam |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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|
|
| Placebo | Drug | Patients allocated to this arm received a five days treatment with Placebo and were contacted at the seventh day by telephone call to investigate the efficacity and the side effects of the treatment. |
|
| paracetamol | Drug | Patients allocated to this arm received a five days treatment with Paracetamol and were contacted at the seventh day by telephone call to investigate the efficacity and the side effects of the treatment. |
|
| D006571 |
| Heterocyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |