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

Renal Colic Clinical Trial

— ONSAIP-RC  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02304783
• Other study ID #: Oral NSAI in RC
• Status: Completed
• Phase: Phase 3
• Start date: January 2014
• Est. completion date: December 2021

Study information

• Verified date: April 2024
• Source: University of Monastir
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1400
• Est. completion date: December 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colic
• Renal Colic

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Tunisia	Emergency Department of University Hospital of Monastir	Monastir

Sponsors (1)

Lead Sponsor	Collaborator
University of Monastir

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   official department site