Status:
NOT_YET_RECRUITING
Comparative Efficacy of IV Dexamethasone vs. Nebulized Salbutamol for Renal Colic Pain in the ED
Lead Sponsor:
University of Monastir
Conditions:
Renal Colic
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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) wh...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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
- Exclusion Criteria:
- 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 salbutamol use
- Known allergy to paracetamol or salbutamol
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06980727
Start Date
June 1 2025
End Date
March 1 2028
Last Update
May 20 2025
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