Nebulized Fentanyl for Respiratory Symptoms in Patients With COVID-19

Phase 3

• Conditions: COVID-19 Pneumonia
• Interventions: Drug: Nebulized Fentanyl

• Registration Number: NCT05165992
• Lead Sponsor: Hamad Medical Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-12
• Study First Submitted: 2021-12-20
• Study First Submitted QC: 2021-12-20
• Study First Posted: 2021-12-21
• Last Update Submitted: 2021-12-27
• Last Update Posted: 2022-01-13
• Study Start: 2022-02
• Primary Completion: 2022-11
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nebulized Fentanyl	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
Nebulized 0.9% Saline Solution	Nebulized Fentanyl	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

Primary Outcome Measures

Name	Time	Method
Breathlessness	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	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	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.