Nebulized Salbutamol in Acute Renal Colic

NCT06276231 | Not Yet Recruiting DMC

• 1 other identifier: SalbuEase
• Study Type: interventional
• Target: 214
• Locations: 0 countries
• Sites: N/A

Brief Summary

A Prospective, double blinded, Randomized efficacy and safety trial of Nebulized Salbutamol in acute renal colic. Research Summary: INTRODUCTION: Pain is a common reason for individuals to seek health care, especially emergency care. Salbutamol has an effect for smooth muscle relaxation of the ureters. The administration of Salbuatmol has been shown to be safe and effective in the treatment of asthma exacerbation, but there have been no studies evaluating the use of neublized salbutamol for the treatment of acute renal colic pain in the emergency department. METHOD: This is a double blinded randomized clinical controlled trial. Two hundred renal colic patients presenting to the emergency department will be randomized to intervention (10 mg nebulized salbutamol) and (10 ml neublized Normal saline) case groups. Both the groups will get the standard treatment (IM diclofenac 75mg) added to the intervention. Their pain before and after intervention will be measured by Numerical Rating scale (NRS pain score). Patient and attending physician will be blinded throughout the study. The Secondry outcomes are safety, need for rescue medications and time to discharge. AIM: The aim of this study is to compare analgesic effects of Nebulized Salbutamol versus Placebo in adult patients with renal colic. PRIMARY OJECTIVES: Analgesic effects of Nebulized Salbutamol on the Numerical Rating scale (NRS). SECONDARY OBJECTIVES: Adverse Events, the need of rescue pain medications and time to discharge. PATEINT POPULATION: Adults (from age 18 to 60 years) who presents to emergency department (ED) at Armed force Hospital with acute flank pain suggestive of renal colic INTERVENTION: Single dose of Nebulized Salbutamol 10mg. CLINICAL MEASURMENT: Numerical pain Analog Scale will be assessed at 0,15,30, 45 and 60 minutes after intervention. Number and dosage of rescue medication, any reported events by patient or attending physician will be documented. OUTCOME: Decrease in pain measures by NRS pain score after Nebulized Salbutamol is given, tolerability and safety evaluation.

Conditions

Renal Colic

Keywords

Salbutamol

Outcome Measures

Primary Outcomes (1)

• Pain reduction at 60 minutes

  The Analgesic effects of Nebulized Salbutamol on patient with renal colic as measured by Numerical rating scale (NRS).Minimum of Zero and Maximum of Ten in Number scale , in which zero will be least pain expiernced and Ten is the worse pain expiernced by the patient. Increasing Number from (zero to ten) meaning Wrosning of pain.

  60 minutes

Secondary Outcomes (4)

• Adverse Event/Side Effects

  60 mintues

• Need of Rescue medications

  60 mintues

• Pain reduction rate.

  15, 30, 45, 60 mintues

• ED revisits

  48 hrs

Study Arms (2)

Control Group

PLACEBO COMPARATOR

Patients in this group will receive the standard treatment (75mg IM Diclofenac ) + nebulized 0.9% normal saline.

Other: 0.9% Normal Saline; Drug: Diclofenac Injection

Intervention Group

EXPERIMENTAL

Patients in this group will receive the standard treatment (75mg IM Diclofenac ) + nebulized 10 mg of Nebulized Salbutamol.

Drug: Salbutamol; Drug: Diclofenac Injection

Interventions

Salbutamol DRUG

Salbutamol 10mg nebulization over 5 minutes ( flow rate 5-7 liters).

Also known as: Nebulized Salbutamol

Intervention Group

0.9% Normal Saline OTHER

Normal saline nebulization over 5 minutes ( flow rate 5-7 liters).

Also known as: Nebulized 0.9% Normal Saline

Control Group

Diclofenac Injection DRUG

75 mg of Diclofenac intramuscular Injection

Also known as: Olfen 75mg IM

Control Group; Intervention Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient with classical acute renal colic symptoms.
• Age ≥ 18 years and \< 60 years
• Hemodynamically stable vital signs.
• Mentally competent patient who can understand and sign the consent form.

You may not qualify if:

• Patients who are allergic to Salbuamtol.
• Renal disease or transplant.
• Patients with pervious myocardial infarction and PCI.
• Active peptic ulcer disease.
• Liver cirrhosis.
• Couagulopathy.
• History of asthma , urticaria, or other allergic-type reactions after taking NSAIDs.
• Patient with any other contraindications to use of NSAIDs.

Sponsors & Collaborators

• Oman Medical Speciality Board: lead

Related Publications (7)

• Chauhan CK, Joshi MJ, Vaidya AD. Growth inhibition of struvite crystals in the presence of herbal extract Commiphora wightii. J Mater Sci Mater Med. 2009 Dec;20 Suppl 1:S85-92. doi: 10.1007/s10856-008-3489-z. Epub 2008 Jun 21.

  PMID: 18568390 BACKGROUND

• Teichman JM. Clinical practice. Acute renal colic from ureteral calculus. N Engl J Med. 2004 Feb 12;350(7):684-93. doi: 10.1056/NEJMcp030813. No abstract available.

  PMID: 14960744 BACKGROUND

• Holdgate A, Pollock T. Systematic review of the relative efficacy of non-steroidal anti-inflammatory drugs and opioids in the treatment of acute renal colic. BMJ. 2004 Jun 12;328(7453):1401. doi: 10.1136/bmj.38119.581991.55. Epub 2004 Jun 3.

  PMID: 15178585 BACKGROUND

• Tabner AJ, Johnson GD, Fakis A, Surtees J, Lennon RI. beta-Adrenoreceptor agonists in the management of pain associated with renal colic: a systematic review. BMJ Open. 2016 Jun 20;6(6):e011315. doi: 10.1136/bmjopen-2016-011315.

  PMID: 27324714 BACKGROUND

• Pickard R, Starr K, MacLennan G, Lam T, Thomas R, Burr J, McPherson G, McDonald A, Anson K, N'Dow J, Burgess N, Clark T, Kilonzo M, Gillies K, Shearer K, Boachie C, Cameron S, Norrie J, McClinton S. Medical expulsive therapy in adults with ureteric colic: a multicentre, randomised, placebo-controlled trial. Lancet. 2015 Jul 25;386(9991):341-9. doi: 10.1016/S0140-6736(15)60933-3. Epub 2015 May 18.

  PMID: 25998582 BACKGROUND

• Wanajo I, Tomiyama Y, Yamazaki Y, Kojima M. Ureteral selectivity of intravenous beta-adrenoceptor agonists in pig model of acute ureteral obstruction: comparison of KUL-7211, a selective beta2/beta3 agonist, with isoproterenol, terbutaline, and CL-316243. Urology. 2011 May;77(5):1266.e1-6. doi: 10.1016/j.urology.2010.12.045. Epub 2011 Mar 12.

  PMID: 21397304 BACKGROUND

• Tomiyama Y, Murakami M, Hayakawa K, Akiyama K, Yamazaki Y, Kojima M, Shibata N, Akahane M. Pharmacological profile of KUL-7211, a selective beta-adrenoceptor agonist, in isolated ureteral smooth muscle. J Pharmacol Sci. 2003 Aug;92(4):411-9. doi: 10.1254/jphs.92.411.

  PMID: 12939526 BACKGROUND

MeSH Terms

Conditions

Renal Colic

Interventions

Albuterol; Saline Solution; Diclofenac

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Mohammed Al Shamsi, MD

  Armed Forces Hospital, Oman

  STUDY DIRECTOR

Central Study Contacts

USAMA ALKHALASI, MD

CONTACT

+96894094001; u.alkhalasi@gmail.com

Said Al Mujaini, MD

CONTACT

+968 9965 9097

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oman Medical Specialty Board Certified Accident and Emergency Specialist

Study Record Dates

• First Submitted: February 17, 2024
• First Posted: February 23, 2024
• Study Start: July 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share