drugset / Trial / NCT06980727

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

NCT06980727

Phase 3 Not yet recruiting 500 enrolled University of Monastir
RandomizedFactorialSingle-blindTreatment

Summary

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.

Timeline

Start
2026-08-08
Primary completion
2027-12-01
Completion
2028-03-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexamethasone Small molecule 8 mg Intravenous
Comparator Terbutaline Small molecule 5 mg Inhaled
Comparator Acetaminophen Small molecule 1000 mg Intravenous