Comparative Efficacy of IV Dexamethasone vs. Nebulized Terbutaline for Renal Colic Pain in the ED

Официальное название

Increment Value of Intravenous Dexametasone Versus Nebulized Terbutaline for Renal Colic Pain Management in the Emergency Department: A Randomized Clinical Trial

Обзор

Adult patients (18-55 years of age) with clinical diagnosis of acute renal colic (sudden sharp colic flank pain with or without radiation to genitalia or groin and with or without urinary symptoms) who had pain score of 5 or more measured by 10-cm visual analogue scale (VAS), will be included. Will be excluded those who had history of cardiovascular, hepatic, renal or metabolic diseases, patients with evidence of sepsis or clinical suspicion of urinary tract infection, hemodynamically unstable patients (systolic blood pressure \<90 mmHg), patients with uncontrolled diabetes, pregnancy, breastfeeding, patients unable to understand verbal and/or written information, patients receiving analgesics within 6 hours before presentation, serum potassium less than 3.7 mmol/l, concomitant use of any beta blockers (including beta-blocker containing eye drops), prolonged-release long-acting β-agonists, use of short-acting β2-agonists within the 6 h preceding presentation to the emergency department, any contraindication to the use of terbutaline, history of drug dependence or chronic consumption of alcohol. Will be also excluded patients with known allergy to paracetamol or terbutaline, patients with abdominal tenderness as a sign of peritoneal inflammation and those with any clinical suspicion for diseases other than urolithiasis, including abdominal aortic aneurysm or dissection.

Вмешательства

• Препарат Terbutaline 2.5 mg
  In this study group, patients will receive 1000mg intravenous injection of paracetamol in combination with 4ml IV normal saline as placebo, and 5mg terbutaline in 5ml nebulisation during 10min.
• Препарат Dexamethasone
  Patients will receive 1000mg intravenous injection of paracetamol in combination with 4ml of 2ml intravenous dexamethasone (8mg) and 2 ml of saline sérum, and 5ml nebulisation of of normal saline during 10min as placebo.
• Препарат Placebo
  Patients will receive 1000mg intravenous injection of paracetamol in combination with 4ml of intravenous saline serum (placebo) with 5ml nebulized of normal saline (placebo) during 10min as placebo.

Первичные конечные точки

• Change level of NRS by 50%. [Срок оценки: 120 minutes post-intervention]

Вторичные конечные точки (2)

• Adverse effects [Срок оценки: 120 minutes post-intervention]
• Rescue analgesia. [Срок оценки: 120 minutes post-intervention]

Критерии участия

Критерии включения

• Adults aged 18-65 years
• Clinical diagnosis of acute renal colic (defined as sudden sharp colicky flank pain with or without radiation to the genitalia or groin, and with or without urinary symptoms)
• Pain score of 5 or more measured using the 10-cm NRS scale

Критерии исключения

• History of cardiovascular, hepatic, renal, or metabolic diseases
• Evidence of sepsis or clinical suspicion of urinary tract infection
• Hemodynamically unstable (systolic blood pressure < 90 mmHg)
• Uncontrolled diabetes
• Pregnancy or breastfeeding
• Inability to understand verbal and/or written information
• Received any analgesics within 6 hours prior to presentation
• Serum potassium < 3.7 mmol/L
• Concomitant use of:

Any beta-blockers (including beta-blocker-containing eye drops)

Prolonged-release long-acting β-agonists

Short-acting β2-agonists within 6 hours prior to presentation

• Contraindication to terbutaline use
• Known allergy to paracetamol or terbutaline
• Abdominal tenderness suggestive of peritoneal inflammation
• Clinical suspicion of conditions other than urolithiasis, including:
• Abdominal aortic aneurysm
• Aortic dissection
• History of drug dependence or chronic alcohol consumption

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Tunisia · 1 центр

• University Hospital Fattouma Bourguiba Monastir — Monastir

Идентификаторы

NCT: NCT06980727 · Renal Colic Terbutaline

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗