RecruitingPhase 2NCT05722782

Oral NSAI Versus Acetaminophen or Placebo as a Discharge Treatment of Non Complicated Renal Colics

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


Sponsor

University of Monastir

Enrollment

500 participants

Start Date

Jul 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria3

  • Contraindication of NSAI treatment
  • Patients non reachable by telephone call
  • Patients that did not receive or use the treatment

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Interventions

DRUGPiroxicam

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

DRUGAcetaminophen

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

DRUGPlacebo

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


Locations(1)

Fattouma Bourguiba University Hospital

Monastir, Tunisia

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NCT05722782


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