Clinical Trial: Oral NSAI Versus Placebo as a Second Line Treatment for Renal Colics

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 Departement for Re

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 Summary:

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 placebo as a second line treatment of renal colics.


Sponsor: University of Monastir

Current Primary Outcome: Efficacity of oral NSAI (telephone call, asking for the recurrence of pain, the reconsultation rates and intervals and the need for other treatments) [ Time Frame: seven days ]

The efficacity of the oral NSAI treatment was evaluated at the seventh day by a telephone call, asking for the recurrence of pain, the reconsultation rates and intervals and the need for other treatments (antalgics...)


Original Primary Outcome: Same as current

Current Secondary Outcome: Safety of NSAI (telephone call, asking for the occurence of NSAI side effects such as abdominal pain, vomiting, rush, bleeding and ect) [ Time Frame: 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


Original Secondary Outcome: Same as current

Information By: University of Monastir

Dates:
Date Received: November 26, 2014
Date Started: January 2014
Date Completion: March 2018
Last Updated: April 1, 2016
Last Verified: April 2016