Oral NSAI Versus Acetaminophen or Placebo as a Discharge Treatment of Non Complicated Renal Colics (NAP-RC)

University of Monastir

Status and phase: Enrolling; Phase 2

Conditions: Renal Colic

Treatments: Drug: Placebo; Drug: Acetaminophen; Drug: Piroxicam

Study type: Interventional

Funder types: Other

Identifiers

NCT05722782

NAP in RC

Details and patient eligibility

About

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.

Full 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

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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500 participants in 3 patient groups, including a placebo group

NSAI

Active Comparator group

Description:

Piroxicam: 20 mg per pill; one pill per day for five days

Treatment:

Drug: Piroxicam

Acetaminophen

Active Comparator group

Description:

Paracetamol: 1000 mg per day for five days

Treatment:

Drug: Acetaminophen

Placebo

Placebo Comparator group

Description:

Placebo: one pill per day for five days

Treatment:

Drug: Placebo