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

NCT06980727 | Not Yet Recruiting Phase 3

• 1 other identifier: Renal Colic Salbutamol
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Renal Colic

Keywords

Renal Colic; Salbutamol; Dexamethasone

Outcome Measures

Primary Outcomes (1)

• Change level of NRS by 50%.

  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.

  120 minutes post-intervention

Secondary Outcomes (2)

• Adverse effects

  120 minutes post-intervention

• Rescue analgesia.

  120 minutes post-intervention

Study Arms (3)

Placebo group

PLACEBO COMPARATOR

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.

Drug: Placebo

Dexamethasone group

ACTIVE COMPARATOR

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.

Drug: Dexamethasone

Salbutamol group

ACTIVE COMPARATOR

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

Drug: Salbutamol 2,5 mg

Interventions

Salbutamol 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 salbutamol in 5ml nebulisation during 10min.

Salbutamol group

Dexamethasone DRUG

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.

Dexamethasone group

Placebo DRUG

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.

Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Monastir: lead

MeSH Terms

Conditions

Renal Colic

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Semir Nouira, Professor

CONTACT

216_731-06046; semir.nouira.urg@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 20, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 20, 2025

Record last verified: 2025-05