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

NCT ID: NCT06980727

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2028-03-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Dexamethasone group

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.

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: 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.

Salbutamol group

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

Group Type: ACTIVE_COMPARATOR

Salbutamol 2,5 mg

Intervention Type: 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.

Placebo group

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

Salbutamol 2,5 mg

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.

Intervention Type: DRUG

Dexamethasone

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.

Intervention Type: DRUG

Placebo

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Monastir

OTHER

Sponsor Role: lead

Responsible Party

Pr. Semir Nouira

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Semir Nouira, Professor

Role: CONTACT

semir.nouira.urg@gmail.com

216_731-06046

Other Identifiers

Renal Colic Salbutamol

Identifier Type: -

Identifier Source: org_study_id