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

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.

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.

Study Overview

• Status: Completed
• Conditions: Renal Colic
• Intervention / Treatment: Drug: Placebo; Drug: paracetamol; Drug: Piroxicam

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 Type: Interventional
• Enrollment (Actual): 1400
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Nouira Semir, PHD; Phone Number: +216 73106000; Email: semir.nouira@rns.tn
• Study Contact Backup: Name: Bzeouich Nasri, MD; Phone Number: +216 52919170; Email: medecinasri@gmail.com

Study Locations

• Tunisia
  • Monastir, Tunisia, 5050
    • Emergency Department of University Hospital of Monastir

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Oral Piroxicam; Piroxicam : 20 mg per pill; one pill per day for five days associated with placebo (1pill) (taken separately)	Drug: Piroxicam; Patients allocated to this arm received, as a second line treatment of renal colics, a five days treatment with 20 mg piroxicam associated with placebo per day and were contacted at the seventh day by telephone call to investigate the efficacity and the side effects of the treatment.; Other Names: Piroxen
Placebo Comparator: Placebo; Placebo: two pills per day for five days (taken separately)	Drug: Placebo; Patients allocated to this arm received a five days treatment with Placebo and were contacted at the seventh day by telephone call to investigate the efficacity and the side effects of the treatment.
Active Comparator: paracetamol; paracetamol: 2000mg per day for five days two pills taken separately)	Drug: paracetamol; Patients allocated to this arm received a five days treatment with Paracetamol and were contacted at the seventh day by telephone call to investigate the efficacity and the side effects of the treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacity of oral NSAI (telephone call, asking for the recurrence of pain, the reconsultation rates and intervals and the need for other treatments)	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)	seven days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	seven days

Collaborators and Investigators

• Sponsor: University of Monastir
• Investigators: Principal Investigator: Semir Nouira, MD, University of Monastir

Publications and helpful links

Helpful Links

• official department site

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: November 26, 2014
• First Submitted That Met QC Criteria: December 1, 2014
• First Posted (Estimated): December 2, 2014

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Renal colic, Piroxicam
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Infant, Newborn, Diseases; Renal Colic; Colic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Acetaminophen; Piroxicam
• Other Study ID Numbers: Oral NSAI in RC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO