Oral NSAI Versus Paracetamol or Placebo as a Second Line Treatment for Renal Colics

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Investigation of the Efficacity and Safety of Oral Non Steroidal Anti Inflammatory (NSAI) Drugs Such as Piroxicam as a Second Line Treatment of Patients Consulting the Emergency Departement for Renal Colics.

Conditions
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Renal Colic

Intervention / Treatment
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* Drug: Piroxicam
* Drug: Placebo
* Drug: paracetamol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 16 years old Consenting to participate in the study Patients treated in the ED for RC No contraindications of NSAI treatment Exclusion Criteria: Patients excluded from the first phase of the study Contraindication of NSAI treatment Patients non reachable by telephone call Patients that did not receive or use the treatment

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral Piroxicam<br>Piroxicam : 20 mg per pill; one pill per day for five days | Drug: Piroxicam<br>* Patients allocated to this arm received, as a second line treatment of renal colics, a five days treatment with 20 mg piroxicam per day and were contacted at the seventh day by telephone call to investigate the efficacity and the side effects of the treatment.<br>* Other names: Piroxen;|
| Placebo Comparator: Placebo<br>Placebo: one pill per day for five days | Drug: Placebo<br>* 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.<br>|
| Active Comparator: paracetamol<br>paracetamol: 1000mg per day for five days | Drug: paracetamol<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 pain, the reconsultation rates and intervals and the need for other treatments (antalgics...) | seven days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of NSAI (telephone call, asking for 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal colic, Piroxicam