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

Phase 3

Not yet recruiting

• Conditions: Renal Colic
• Interventions: Drug: Placebo; Drug: Dexamethasone; Drug: Salbutamol 2,5 mg

• Registration Number: NCT06980727
• Lead Sponsor: University of Monastir

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) 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 salbutamol, history of drug dependence or chronic consumption of alcohol. Will be also excluded patients with known allergy to paracetamol or salbutamol, 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-07
• Study First Submitted QC: 2025-05-16
• Last Update Submitted: 2025-05-16
• Study First Posted: 2025-05-20
• Last Update Posted: 2025-05-20
• Study Start: 2025-06-01
• Primary Completion: 2027-12-01
• Study Completion: 2028-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	In this group patient will receive 1000mg intravenous injection of paracetamol in combination with 4ml intravenous normal saline as placebo, and 5ml nebulisation of normal saline during 10min.
Dexamethasone group	Dexamethasone	In this group, patients will receive 1000mg intravenous injection of paracetamol in combination with 4ml intravenous dexamethasone (8mg), and 5ml nebulisation of of normal saline during 10min as placebo.
Salbutamol group	Salbutamol 2,5 mg	In this group, patients will receive 1000mg intravenous injection of paracetamol in combination with 4ml IV normal saline as placebo, and 5mg salbutamol in 5ml nebulisation during 10min

Primary Outcome Measures

Name	Time	Method
Change level of NRS by 50%.	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 Outcome Measures

Name	Time	Method
Adverse effects	120 minutes post-intervention	The occurrence of adverse effects
Rescue analgesia.	120 minutes post-intervention	The number of patients who need rescue analgesia.