跳至主要内容
临床试验/NCT06276231
NCT06276231尚未招募不适用

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

Oman Medical Speciality Board0 个研究点目标入组 214 人开始时间: 2024年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
214
主要终点
Pain reduction at 60 minutes

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Control Group

Placebo Comparator

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

干预措施: 0.9% Normal Saline (Other)

Control Group

Placebo Comparator

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

干预措施: Diclofenac Injection (Drug)

Intervention Group

Experimental

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

干预措施: Salbutamol (Drug)

Intervention Group

Experimental

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

干预措施: Diclofenac Injection (Drug)

结局指标

主要结局

Pain reduction at 60 minutes

时间窗: 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.

次要结局

  • Adverse Event/Side Effects(60 mintues)
  • Need of Rescue medications(60 mintues)
  • Pain reduction rate.(15, 30, 45, 60 mintues)
  • ED revisits(48 hrs)

研究者

发起方
Oman Medical Speciality Board
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Usama Al-Khalasi

Oman Medical Specialty Board Certified Accident and Emergency Specialist

Oman Medical Speciality Board

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