A Randomized Study Comparing of Three Doses Nebulized Fentanyl in Older Adults with Severe Musculoskeletal Pain At the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Efficacy in pain reduction following nebulized fentanyl administration at different dosages.
研究概览
简要总结
This clinical trial compares three different nebulized fentanyl dosages for older persons experiencing severe musculoskeletal pain at the emergency department.
The main objective is:
Does the effectiveness of nebulized fentanyl at dosages of 2 mcg/kg, 3 mcg/kg, and 4 mcg/kg at 30 minutes differ in older patients who report to the emergency room with pain from musculoskeletal injuries?
Secondary outcome are:
- Incidence of adverse effects after drug administration at minutes 0, 15, 30, 45, 60, 75, 90, 105, 120
- Incidence of receiving other pain relief treatments (rescue therapy) in minutes 30, 45, 60, 75, 90, 105, 120 Participants will receive an explanation of the study and possible side effects, which may take approximately 5-10 minutes, without affecting the primary treatment of the patients. Consent will be obtained in this study, along with signing or fingerprinting as evidence in the consent form.
详细描述
Participants will receive nebulized fentanyl for pain reduction at the pre-determined randomized dose, then researchers will follow up assessments of pain levels, vital signs, and any side effects at various intervals.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 99 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age more than or equal 65 years old.
- •Presented with musculoskeletal pain within 3 days.
- •Pain score on verbal numeric rating scale ≥ 5.
排除标准
- •Patients need immediate intervention.
- •Patients need acute rescue for acute coronary syndrome, respiratory failure, and stroke.
- •Creatinine clearance < 30 ml/min, Cirrhosis stage III, IV (present with ascites and varices).
- •Trauma >2 organ.
- •Comorbidities of chronic obstructive pulmonary disease.
- •Take MAO inhibitors within 14 days.
- •History of opioid used within 8 hours.
- •History of alcohol or drug abuse.
- •History of fentanyl allergy.
- •Patients with difficulty to communication (e.g. altered mental status, severe dementia (define by 6-items cognitive screening > 12, language barrier).
研究组 & 干预措施
Nebulized fentanyl 2 mcg/kg
The researcher prepared fentanyl (the researcher informed the in-charge nurse to open the medicine cabinet and double-checked the dosage with the in-charge nurse). The dosage was 2 micrograms per kilogram of body weight (calculated based on the patient's actual weight in kilograms). The medication was contained in a nebulizer. It was then mixed with normal saline (0.9% normal saline) to a total volume of 5 milliliters and administered via nebulization.
干预措施: Nebulized fentanyl (Drug)
Nebulized fentanyl 3 mcg/kg
The researcher prepared fentanyl (the researcher informed the in-charge nurse to open the medicine cabinet and double-checked the dosage with the in-charge nurse). The dosage was 3 micrograms per kilogram of body weight (calculated based on the patient's actual weight in kilograms). The medication was contained in a nebulizer. It was then mixed with normal saline (0.9% normal saline) to a total volume of 5 milliliters and administered via nebulization.
干预措施: Nebulized fentanyl (Drug)
Nebulized fentanyl 4 mcg/kg
The researcher prepared fentanyl (the researcher informed the in-charge nurse to open the medicine cabinet and double-checked the dosage with the in-charge nurse). The dosage was 4 micrograms per kilogram of body weight (calculated based on the patient's actual weight in kilograms). The medication was contained in a nebulizer. It was then mixed with normal saline (0.9% normal saline) to a total volume of 5 milliliters and administered via nebulization.
干预措施: Nebulized fentanyl (Drug)
结局指标
主要结局
Efficacy in pain reduction following nebulized fentanyl administration at different dosages.
时间窗: 30 Minutes
Efficacy in pain reduction following nebulized fentanyl administration at dosages of 2 mcg/kg, 3 mcg/kg, and 4 mcg/kg in elderly patients presenting to the emergency department with musculoskeletal pain, using verbal numerical rating scale (VNRS) VNRS score ranges from 0 to 10, with a higher score indicating more severe pain. Ten indicates the worst pain, and zero indicates no pain.
次要结局
- Adverse events following nebulized fentanyl administration at different dosages.(0, 15, 30, 45, 60, 75, 90, 105, 120 Minutes)
- Events of rescue therapy following nebulized fentanyl administration at different dosages.(30, 45, 60, 75, 90, 105, 120 Minutes)
研究者
Thananda Trakarnvanich
Doctor
Bangkok Metropolitan Administration Medical College and Vajira Hospital