Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-25 @ 5:19 AM
NCT ID:
NCT06980727
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06980727
Study Brief:
Protocol Section:
NCT06980727