Oral NSAI Versus Acetaminophen or Placebo as a Discharge Treatment of Non Complicated Renal Colics

NCT05722782 | Recruiting Phase 2

• 1 other identifier: NAP in RC
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Treatment with NSAI in renal colics has not been well investigated and there is no clear recommendations regarding this subject. The aim of this study is to determine if an oral NSAI treatment is beneficial in patients discharged for the emergency department after the first line treatment of a renal colic investigating the reccurence of pain, the reconsultation rates and the admissions.

Conditions

Renal Colic

Keywords

Renal Colic; NSAI; Acetaminophen

Outcome Measures

Primary Outcomes (1)

• Efficacity of oral NSAI

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

  07 days

Secondary Outcomes (1)

• Safety of NSAI

  07 days

Study Arms (3)

NSAI

ACTIVE COMPARATOR

Piroxicam: 20 mg per pill; one pill per day for five days

Drug: Piroxicam

Acetaminophen

ACTIVE COMPARATOR

Paracetamol: 1000 mg per day for five days

Drug: Acetaminophen

Placebo

PLACEBO COMPARATOR

Placebo: one pill per day for five days

Drug: Placebo

Interventions

Piroxicam DRUG

Patients allocated to this arm received , as a second line treatment of renal colics , a five days treatment with 20 mg piroxicam per day and were contacted at the seventh day by telephone call to investigate the efficacy and the side effects of the treatment

Also known as: Piroxen

NSAI

Acetaminophen DRUG

Patients allocated to this arm received , as a second line treatment of renal colics , a five days treatment with 1000 mg Acetaminophen per day and were contacted at the seventh day by telephone call to investigate the efficacy and the side effects of the treatment

Acetaminophen

Placebo DRUG

Patients allocated to this arm received , as a second line treatment of renal colics , a five days treatment with placebo per day and were contacted at the seventh day by telephone call to investigate the efficacy and the side effects of the treatment

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years old
• Consenting to participate in the study
• Patients treated in the ED for RC
• No contraindications of NSAI or paracetamol treatment

You may not qualify if:

• Contraindication of NSAI treatment
• Patients non reachable by telephone call
• Patients that did not receive or use the treatment

Sponsors & Collaborators

• University of Monastir: lead

Study Sites (1)

Fattouma Bourguiba University Hospital

Monastir, 5000, Tunisia

RECRUITING

MeSH Terms

Conditions

Renal Colic

Interventions

Piroxicam; Acetaminophen

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Central Study Contacts

Nouira semir, MD

CONTACT

73106000; semir.nouira@rns.tn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: February 10, 2023
• Study Start: July 1, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 14, 2023

Record last verified: 2023-11

Locations

TU (1)