Nebulized Salbutamol in Acute Renal Colic

March 15, 2024 updated by: Usama Al-Khalasi, Oman Medical Speciality Board

Comparative Efficacy of Nebulized Salbutamol in Alleviating Acute Renal Colic Pain: A Randomized Clinical Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Renal colic is recognized as one of the most intense types of pain a person can experience. The occurrence of renal stones is widespread, affecting people of all ages, genders, and races, with a lifetime risk of 12%. Men, especially those between 20-49 years, are more commonly affected than women. Recent studies show an increasing number of cases in both developed and developing countries over the past years. In Oman, while renal stones are a common health issue, the exact number of cases is not known due to a lack of data. Regional research indicates a prevalence between 4-20%, with twice as many men affected as women.

The formidable impact of renal colic extends to the realm of emergency medicine, as pain ranks as the paramount driver of emergency department (ED) visits, constituting nearly 45% of all ED admissions, particularly among those grappling with moderate to severe pain. Effective pain management in this context has profound implications, fostering improved patient satisfaction, shorter hospital stays, and reduced mortality rates. Acute renal colic, characterized by its excruciating intensity, is a frequent motive for ED visits across the globe, compelling individuals to seek immediate relief. The pain in renal colic is intricately linked to the stone's location within the urinary system and may manifest concomitantly with hematuria, urinary flow obstruction, infections, or hydronephrosis.

The primary concern for individuals confronted with renal colic is the rapid alleviation of pain. The choice of analgesic hinges on a complex interplay of factors, including availability, safety, efficacy, cost considerations, and the shared preferences of both patients and healthcare providers. Within this spectrum, nonsteroidal anti-inflammatory drugs (NSAIDs) often ascend as the preferred initial choice for pain management, guided by multiple clinical practice guidelines. NSAIDs hold sway over opioids due to their superior pain relief, diminished side effect profile, and reduced demand for adjunctive painkillers.

Salbutamol, a widely employed beta-adrenoreceptor agonist, finds its niche in diverse medical conditions, distinguished by its favorable safety profile. Beta-adrenoreceptor agonists manifest a multifaceted approach to addressing the etiology of renal colic pain, countering factors such as ureteral spasms and inflammation. They exhibit the capacity to induce ureteral relaxation, mitigate muscular contractions, and alleviate renal pressure. Importantly, salbutamol's distinctive pharmacokinetics allow for both systemic and direct urinary system action, as approximately 60% of an intravenously administered dose is excreted unchanged in urine.

While dedicated clinical trials focused on beta agonists for renal colic pain relief are lacking, a substantial body of evidence lends credence to their potential efficacy. This intriguing prospect warrants further exploration through rigorous research endeavors. Given the existing foundation of evidence, a systematic investigation into this treatment paradigm is a logical progression. Many studies have looked at treatments that might expedite stone passage. While this isn't the main focus of this trial, it is one of the secondary goals as previous research suggest salbutamol role in uteral relaxation.

Salbutamol's rapid onset of action, occurring within minutes, renders it an attractive option for addressing the sudden and severe pain characteristic of renal colic in the ED setting. Familiarity among emergency department staff further enhances its appeal, ensuring ease of administration. In this study, we propose a 10 mg nebulized salbutamol dose, an approved dosage that achieves systemic absorption, ensuring a therapeutic effect. Furthermore, this dosage is unlikely to exert undue influence on electrolyte balance and adheres to established guidelines for managing elevated blood potassium levels.

Considering safety, salbutamol's side effect profile, characterized by mild effects such as increased heart rate and shivering, is well-documented and understood, particularly when compared with alternative analgesics. Notably, salbutamol exhibits a relatively modest impact on blood potassium levels (lowering potassium level) compared to other analogous medications. However, studies have revealed that any potential potassium level alterations are primarily observed in individuals who are regular users of salbutamol, with no substantive changes noted in blood potassium levels in research involving salbutamol use, especially at doses ranging from 5mg to 10mg.

The scientific rationale underpinning the consideration of beta-agonists, like salbutamol, for renal colic pain relief rests upon their ability to ameliorate ureteral spasms, a principal contributor to the affliction of pain, subsequently abating the associated agony. Support for this hypothesis stems from an extensive body of evidence encompassing laboratory studies, animal experiments, and human investigations. Studies in human subjects have corroborated the premise that agents inducing ureteral relaxation can mitigate pain and potentially reduce the need for additional analgesic interventions.

In summary, the utilization of salbutamol as a potential therapeutic agent for renal colic pain relief represents an exciting frontier in medical research, offering a multifaceted approach to pain management. Its rapid onset, established safety profile, and plausible mechanistic underpinnings position it as a compelling candidate for further exploration and investigation. By embarking on this research journey, we aim to enhance our understanding of effective renal colic pain relief strategies and, in turn, advance patient care in this challenging clinical context.

Study Type

Interventional

Enrollment (Estimated)

214

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Said Al Mujaini, MD
  • Phone Number: +968 9965 9097

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control Group
Patients in this group will receive the standard treatment (75mg IM Diclofenac ) + nebulized 0.9% normal saline.
Other: 0.9% Normal Saline
Normal saline nebulization over 5 minutes ( flow rate 5-7 liters).
Other Names:
  • Nebulized 0.9% Normal Saline
Drug: Diclofenac Injection
75 mg of Diclofenac intramuscular Injection
Other Names:
  • Olfen 75mg IM
Experimental: Intervention Group
Patients in this group will receive the standard treatment (75mg IM Diclofenac ) + nebulized 10 mg of Nebulized Salbutamol.
Drug: Diclofenac Injection
75 mg of Diclofenac intramuscular Injection
Other Names:
  • Olfen 75mg IM
Drug: Salbutamol
Salbutamol 10mg nebulization over 5 minutes ( flow rate 5-7 liters).
Other Names:
  • Nebulized Salbutamol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain reduction at 60 minutes
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Event/Side Effects
Time Frame: 60 mintues
sides effects will be monitored during the study protocol period like (nausea , vomiting , dizziness )
60 mintues
Need of Rescue medications
Time Frame: 60 mintues
rate of recuse medications (Opioids )
60 mintues
Pain reduction rate.
Time Frame: 15, 30, 45, 60 mintues
The rate of pain reduction will be monitored during the 60 minutes at each 15-minute interval.
15, 30, 45, 60 mintues
ED revisits
Time Frame: 48 hrs
Patient will be followed up after 48 hrs by a follow-up call to document ED revisits.
48 hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oman Medical Speciality Board

Investigators

  • Study Director: Mohammed Al Shamsi, MD, Armed Forces Hospital, Oman

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

February 17, 2024

First Submitted That Met QC Criteria

February 17, 2024

First Posted (Actual)

February 23, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SalbuEase

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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