Which works better for kidney stone pain in the ED: IV dexamethasone or nebulized terbutaline?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional trial compares two active treatments, dexamethasone given intravenously and terbutaline delivered by nebulizer, against placebo for acute renal colic pain in adults presenting to the emergency department. Eligible participants are adults 18–65 with sudden flank pain of at least moderate intensity and no major exclusion criteria such as unstable vital signs or significant comorbidities. Participants are randomized to receive one of the study interventions and are assessed for pain relief and safety outcomes. The study is conducted at a single site, University Hospital Fattouma Bourguiba Monastir, led by the University of Monastir.

Why it matters

Who can join: the full rules

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 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

Where it's running

• University Hospital Fattouma Bourguiba Monastir
  Monastir, Monastir Governorate, Tunisia Recruiting

Study contacts

• Study coordinator: Semir Nouira, Professor
• Email: semir.nouira.urg@gmail.com
• Phone: 216_731-06046

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Probiotics for reducing crying in infants with colic

  This study is testing if a probiotic can help reduce crying in babies with colic compared to a placebo.

  Recruiting at 3 sites Phase 2 Lallemand Health Solutions · Bécon-les-Granits and 9 other locations · NCT06385054

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.