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

Официальное название

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 Department for Renal Colics

Обзор

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.

Подробное описание

Renal colic (RC) are a frequent cause of consultation in the emergency departement (ED). It counts 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 non solid scientific arguments.

Piroxicam, a non-selective COX inhibitor drug appared to the oxicam class of NSAI, is widely used to treat rhumatoid and inflammatory disesases, and often prescribed in Tunisia as a second line treatment of RC.

In this study, the investigators aimed to investigate the efficiency and safety of the use of oral NSAI drugs (piroxicam) compared to Acetaminophen or placebo as a second line treatment of renal colics

Вмешательства

• Препарат Piroxicam
  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
• Препарат Acetaminophen
  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
• Препарат Placebo
  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

Первичные конечные точки

• Efficacity of oral NSAI [Срок оценки: 07 days]

Вторичные конечные точки (1)

• Safety of NSAI [Срок оценки: 07 days]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Tunisia · 1 центр

• Fattouma Bourguiba University Hospital — Monastir

Идентификаторы

NCT: NCT05722782 · NAP in RC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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