Clinical trial NCT02304783: Oral NSAI Versus Paracetamol or Placebo as a Second Line Treatment for Renal Colics
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 Renal Colics.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Colic
Keywords: Renal colic, Piroxicam
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2014-12-02
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacity of oral NSAI (telephone call, asking for the recurrence of pain, the reconsultation rates and intervals and the need for other treatments)
timeFrame: seven days
Secondary outcomes:
measure: 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)
timeFrame: seven days
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Emergency Department of University Hospital of Monastir
Study officials:
affiliation: University of Monastir
name: Semir Nouira, MD
role: PRINCIPAL_INVESTIGATOR
References: