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NCT Number: NCT06980727

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

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.

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Key information

Conditions

Renal Colic Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital Fattouma Bourguiba Monastir

Monastir, Monastir Governorate, 5000, Tunisia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Terbutaline 2.5 mg

Drug

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.

Dexamethasone

Drug

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.

Placebo

Drug

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.

Primary outcomes

  1. Change level of NRS by 50%.

    Time frame: 120 minutes post-intervention

    The efficacy of the drug with regards to reducing the Numerical Rating Scale (NRS) A scale from 0 to 10 with 0 meaning "no pain" and 10 meaning "worst imaginable pain."during the follow-up. Criteria for treatment response was determined as pain reduction level by 50% based on the primary NRS score or NRS score of four or lower.

Secondary outcomes

  1. Adverse effects

    Time frame: 120 minutes post-intervention

    The occurrence of adverse effects

  2. Rescue analgesia.

    Time frame: 120 minutes post-intervention

    The number of patients who need rescue analgesia.

Study contacts

Contact information is provided by the study sponsor or research team.

Semir Nouira, Professor

CONTACT

[email protected]

216_731-06046

Sponsors and collaborators

Lead sponsor

University of Monastir

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
May 20, 2025
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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