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

University of Monastir

Status and phase: Not yet enrolling; Phase 3

Conditions: Renal Colic

Treatments: Drug: Placebo; Drug: Salbutamol 2,5 mg; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT06980727

Renal Colic Salbutamol

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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300 participants in 3 patient groups, including a placebo group

Placebo group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Dexamethasone group

Active Comparator group

Description:

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.

Treatment:

Drug: Dexamethasone

Salbutamol group

Active Comparator group

Description:

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

Treatment:

Drug: Salbutamol 2,5 mg