Oral NSAI Versus Acetaminophen or Placebo as a Discharge Treatment of Non Complicated Renal Colics
NCT ID: NCT05722782
Last Updated: 2023-11-14
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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RECRUITING
PHASE2
500 participants
INTERVENTIONAL
2023-07-01
2027-12-31
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 department after the first line treatment of a renal colic investigating the reccurence of pain, the reconsultation rates and the admissions.
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Detailed Description
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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 non solid scientific arguments.
Piroxicam, a non-selective COX inhibitor drug appared to the oxicam class of NSAI, is widely used to treat rhumatoid and inflammatory disesases, and often prescribed in Tunisia as a second line treatment of RC.
In this study, the investigators aimed to investigate the efficiency and safety of the use of oral NSAI drugs (piroxicam) compared to Acetaminophen or placebo as a second line treatment of renal colics
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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NSAI
Piroxicam: 20 mg per pill; one pill per day for five days
Piroxicam
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 efficacy and the side effects of the treatment
Acetaminophen
Paracetamol: 1000 mg per day for five days
Acetaminophen
Patients allocated to this arm received , as a second line treatment of renal colics , a five days treatment with 1000 mg Acetaminophen per day and were contacted at the seventh day by telephone call to investigate the efficacy and the side effects of the treatment
Placebo
Placebo: one pill per day for five days
Placebo
Patients allocated to this arm received , as a second line treatment of renal colics , a five days treatment with placebo per day and were contacted at the seventh day by telephone call to investigate the efficacy 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 per day and were contacted at the seventh day by telephone call to investigate the efficacy and the side effects of the treatment
Acetaminophen
Patients allocated to this arm received , as a second line treatment of renal colics , a five days treatment with 1000 mg Acetaminophen per day and were contacted at the seventh day by telephone call to investigate the efficacy and the side effects of the treatment
Placebo
Patients allocated to this arm received , as a second line treatment of renal colics , a five days treatment with placebo per day and were contacted at the seventh day by telephone call to investigate the efficacy 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 or paracetamol treatment
Exclusion Criteria
* 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
Locations
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Fattouma Bourguiba University Hospital
Monastir, , Tunisia
Countries
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Central Contacts
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Facility Contacts
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samir nouira, MD
Role: primary
Other Identifiers
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NAP in RC
Identifier Type: -
Identifier Source: org_study_id
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