Oral NSAI Versus Acetaminophen or Placebo as a Discharge Treatment of Non Complicated Renal Colics
- Registration Number
- NCT05722782
- Lead Sponsor
- University of Monastir
- Brief Summary
Treatment with NSAI in renal colics has not been well investigated and there is no clear recommendations regarding this subject.
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.
- Detailed Description
Renal colic (RC) are a frequent cause of consultation in the emergency departement (ED). It counts 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 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- Over 18 years old
- Consenting to participate in the study
- Patients treated in the ED for RC
- No contraindications of NSAI or paracetamol treatment
- Contraindication of NSAI treatment
- Patients non reachable by telephone call
- Patients that did not receive or use the treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo: one pill per day for five days NSAI Piroxicam Piroxicam: 20 mg per pill; one pill per day for five days Acetaminophen Acetaminophen Paracetamol: 1000 mg per day for five days
- Primary Outcome Measures
Name Time Method Efficacity of oral NSAI 07 days The efficacity of the oral NSAI treatment was evaluated at the seventh day by a telephone call, asking for the reccurence of pain, the reconsultation rates and intervals and the need for other treatments (antalgics...)
- Secondary Outcome Measures
Name Time Method Safety of NSAI 07 days Safety was evaluated by a telephone call asking for the occurence of NSAI side effects such as abdominal pain , vomiting , rush, bleeding or others
Trial Locations
- Locations (1)
Fattouma Bourguiba University Hospital
🇹🇳Monastir, Tunisia