Oral NSAI Versus Paracetamol or Placebo as a Second Line Treatment for Renal Colics

Phase 3

Completed

• Conditions: Renal Colic
• Interventions: Drug: Placebo; Drug: Piroxicam; Drug: paracetamol

• Registration Number: NCT02304783
• Lead Sponsor: University of Monastir

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-11-26
• Study First Submitted QC: 2014-12-01
• Study First Posted: 2014-12-02
• Primary Completion: 2021-06
• Study Completion: 2021-12
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo: two pills per day for five days (taken separately)
Oral Piroxicam	Piroxicam	Piroxicam : 20 mg per pill; one pill per day for five days associated with placebo (1pill) (taken separately)
paracetamol	paracetamol	paracetamol: 2000mg per day for five days two pills taken separately)

Primary Outcome Measures

Name	Time	Method
Efficacity of oral NSAI (telephone call, asking for the recurrence of pain, the reconsultation rates and intervals and the need for other treatments)	seven days	The efficacity of the oral NSAI treatment was evaluated at the seventh day by a telephone call, asking for the recurrence of painand the readmission rates)

Secondary Outcome Measures

Name	Time	Method
Safety of NSAI (telephone call, asking for mean time to recurrence and the occurence of NSAI side effects such as abdominal pain, vomiting, rush, bleeding and ect)	seven days	The efficacity of the oral NSAI treatment was evaluated at the seventh day by a telephone call, asking for the occurence of NSAI side effects such as abdominal pain, vomiting, rush, bleeding and ect

Trial Locations

Locations (1)

Emergency Department of University Hospital of Monastir; 🇹🇳 Monastir, Tunisia