Nebulized Fentanyl for Respiratory Symptoms in Patients With COVID-19 (Ventanyl Trial)
试验速览
- 阶段
- 3 期
- 入组人数
- 200
- 主要终点
- Breathlessness
研究概览
简要总结
Patients with Coronavirus Disease (COVID-19) experience distressing and challenging to manage respiratory symptoms. Interventions such as Oxygen (O2) therapy, oral opiates, and traditional nebulizers like ipratropium bromide and salbutamol, are variably effective, and therapeutic responses in individual patients are difficult to predict. The purpose of this study is to investigate the efficacy of nebulized fentanyl citrate on dyspnea, cough, and throat pain in patients with COVID-19, as well as evaluate the safety with any potential adverse events.
In COVID-19, about 59% of patients will exhibit cough, 35% generalized body ache and sore throat and 31% will have dyspnea. Nebulized Lidocaine, magnesium, and opioids are alternative methods for the management of respiratory symptoms in various patients. Fentanyl nebulization was found to be effective in decreasing dyspnea in chronic obstructive pulmonary disease (COPD) patients by decreasing the rate of spontaneous respiratory rate, modulating cortical activity, and diminishing the brain stem chemoreceptor response to hypoxia and hypercarbia. The investigators hypothesize that nebulized fentanyl is superior to nebulized saline in suppressing cough, respiratory drive, improving breathlessness or dyspnea with the additional advantage of throat pain relief with minimal adverse effects in patients with COVID-19.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 - 65 years
- •Confirmed diagnosis (COVID-19) - positive PCR
- •Tachypnoea (Respiratory rate> 30/min)
- •Ability to provide informed consent and perform all study procedures
排除标准
- •History of allergy or adverse reaction to fentanyl or other opioids
- •Pregnancy
- •Active neuromuscular or musculoskeletal disease.
- •Active malignancy
- •Morbid obesity (Body mass index >40)
- •Use of opioids in the previous 4 weeks.
- •Inability to provide informed consent and perform all study procedures.
研究组 & 干预措施
Nebulized Fentanyl
Intervention group (n=100): Administration of nebulized Fentanyl (25 μg in 5 ml of normal saline) over 15 mins, thrice daily using a traditional nebulizer. Treatment duration - 48 hours
干预措施: Nebulized Fentanyl (Drug)
Nebulized 0.9% Saline Solution
Control group (n=100): Administration of nebulized 0.9% saline solution (5 ml of normal saline), over 15 minutes, thrice daily using a traditional nebulizer. Treatment duration - 48 hours
干预措施: Nebulized Fentanyl (Drug)
结局指标
主要结局
Breathlessness
时间窗: 15-minutes post-treatment
The severity of breathlessness will be measured by the 10-point Borg Scale. Patients will be instructed to use this scale to rate the difficulty of breathing. It starts at number 0 where breathing is causing no difficulty at all and progresses through to number 10 where breathing difficulty is maximal.
Throat Pain
时间窗: 15-minutes post-treatment
Throat pain will be graded by the Numerical Rating Scale (NRS), in which patients will be asked to circle the number between 0 and 10, that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the upper limit represents 'the worst pain ever possible'.
Cough
时间窗: 15-minutes post-treatment
The cough severity score represents a simple instrument, using a 10 point scale, where the patient can indicate the severity of their cough between the two extremes: one for no cough while 100 mm is the most severe cough.
次要结局
未报告次要终点