Oral NSAI Versus Paracetamol or Placebo as a Second Line Treatment for Renal Colics
NCT ID: NCT02304783
Last Updated: 2024-04-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1400 participants
INTERVENTIONAL
2014-01-31
2021-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Oral Piroxicam
Piroxicam : 20 mg per pill; one pill per day for five days associated with placebo (1pill) (taken separately)
Piroxicam
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.
Placebo
Placebo: two pills per day for five days (taken separately)
Placebo
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
paracetamol: 2000mg per day for five days two pills taken separately)
paracetamol
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.
Interventions
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Piroxicam
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.
Placebo
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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Consenting to participate in the study
* Patients treated in the ED for RC
* No contraindications of NSAI treatment
Exclusion Criteria
* Contraindication of NSAI treatment
* Patients non reachable by telephone call
* Patients that did not receive or use the treatment
18 Years
ALL
No
Sponsors
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University of Monastir
OTHER
Responsible Party
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Pr. Semir Nouira
Professor
Principal Investigators
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Semir Nouira, MD
Role: PRINCIPAL_INVESTIGATOR
University of Monastir
Locations
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Emergency Department of University Hospital of Monastir
Monastir, , Tunisia
Countries
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Related Links
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official department site
Other Identifiers
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Oral NSAI in RC
Identifier Type: -
Identifier Source: org_study_id
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