Comparing oral NSAI to acetaminophen or placebo for treating renal colic after emergency discharge
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 Department for Renal Colics
This study is testing whether a pain medication called piroxicam works better than acetaminophen or a placebo for adults who have been treated for kidney stone pain in the emergency room.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Monastir Academic / other |
| Locations | 1 site (Monastir) |
| Trial ID | NCT05722782 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of oral non-steroidal anti-inflammatory drugs (NSAI), specifically piroxicam, in treating patients discharged from the emergency department after experiencing renal colic. The research aims to assess the recurrence of pain, reconsultation rates, and hospital admissions among patients receiving piroxicam compared to those receiving acetaminophen or a placebo. By focusing on a common yet under-researched condition, the study seeks to provide clearer recommendations for outpatient treatment of renal colic. The study will include adult patients who have been treated for renal colic in the emergency department and consent to participate.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who have been treated for renal colic in the emergency department and can consent to participate.
Not a fit: Patients with contraindications to NSAI or acetaminophen treatment will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective outpatient treatment option for patients suffering from renal colic.
How similar studies have performed: While there is limited research specifically on oral NSAI for renal colic, similar studies have explored NSAI use in pain management, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Over 18 years old * Consenting to participate in the study * Patients treated in the ED for RC * No contraindications of NSAI or paracetamol treatment Exclusion Criteria: * Contraindication of NSAI treatment * Patients non reachable by telephone call * Patients that did not receive or use the treatment
Where this trial is running
Monastir
- Fattouma Bourguiba University Hospital — Monastir, Tunisia (Recruiting)
Study contacts
- Study coordinator: Nouira semir, MD
- Email: semir.nouira@rns.tn
- Phone: 73106000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.