Oral NSAI Versus Paracetamol or Placebo as a Second Line Treatment for Renal Colics (ONSAIP-RC)

University of Monastir

Status and phase: Completed; Phase 3

Conditions: Renal Colic

Treatments: Drug: Piroxicam; Drug: Placebo; Drug: paracetamol

Study type: Interventional

Funder types: Other

Identifiers

NCT02304783

Oral NSAI in RC

Details and patient eligibility

About

Outpatients treatment with NSAI in renal colics has not been well investigated and there is no clear recommendations regarding this matter.

The aim of this study is to determine if an oral NSAI treatment is beneficial in patients discharged for the emergency departement after the first line treatment of a renal colic investigating the recurrence of pain, the reconsultation rates and the admissions.

Full description

Renal colic (RC)are a frequent cause of consultation in the emergency departement (ED).

They count 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 no solid scientific arguments.

Piroxicam, a non-selective COX inhibitor drug appared to the Oxicam class of NSAI, is widely used to treat rheumatoid conditions and other inflammatory conditions and often prescribed in Tunisia as a second line treatment of RC.

In this study, we aimed to investigate the efficiency and safety of the use of oral NSAI drugs (Piroxicam) compared to paracetamol or placebo as a second line treatment of renal colics.

Enrollment: 1,400 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 treatment

Exclusion criteria

• Patients excluded from the first phase of the study
• 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: Double Blind

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1,400 participants in 3 patient groups, including a placebo group

Oral Piroxicam

Active Comparator group

Description:

Piroxicam : 20 mg per pill; one pill per day for five days associated with placebo (1pill) (taken separately)

Treatment:

Drug: Piroxicam

Placebo

Placebo Comparator group

Description:

Placebo: two pills per day for five days (taken separately)

Treatment:

Drug: Placebo

paracetamol

Active Comparator group

Description:

paracetamol: 2000mg per day for five days two pills taken separately)

Treatment:

Drug: paracetamol