Nebulized Fentanyl for Respiratory Symptoms in Patients With COVID-19

COVID-19 Pneumonia Clinical Trial

— Ventanyl  

Official title:

Nebulized Fentanyl for Respiratory Symptoms in Patients With COVID-19 (Ventanyl Trial)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05165992
• Other study ID #: MRC-01-21-798
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: February 2022
• Est. completion date: December 2022

Study information

• Verified date: December 2021
• Source: Hamad Medical Corporation
• Contact: Abdulqadir J Nashwan
• Phone: 0097466473549
• Email: ANashwan[@]hamad.qa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pneumonia
• Signs and Symptoms, Respiratory

Intervention

Drug:
• Nebulized Fentanyl
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hamad Medical Corporation

References & Publications (9)

Afolabi TM, Nahata MC, Pai V. Nebulized opioids for the palliation of dyspnea in terminally ill patients. Am J Health Syst Pharm. 2017 Jul 15;74(14):1053-1061. doi: 10.2146/ajhp150893. Review. — View Citation

Benyamin R, Trescot AM, Datta S, Buenaventura R, Adlaka R, Sehgal N, Glaser SE, Vallejo R. Opioid complications and side effects. Pain Physician. 2008 Mar;11(2 Suppl):S105-20. Review. — View Citation

Boyden JY, Connor SR, Otolorin L, Nathan SD, Fine PG, Davis MS, Muir JC. Nebulized medications for the treatment of dyspnea: a literature review. J Aerosol Med Pulm Drug Deliv. 2015 Feb;28(1):1-19. doi: 10.1089/jamp.2014.1136. Epub 2014 Jun 10. Review. — View Citation

Elliott J, Whitaker M, Bodinier B, Eales O, Riley S, Ward H, Cooke G, Darzi A, Chadeau-Hyam M, Elliott P. Predictive symptoms for COVID-19 in the community: REACT-1 study of over 1 million people. PLoS Med. 2021 Sep 28;18(9):e1003777. doi: 10.1371/journal.pmed.1003777. eCollection 2021 Sep. — View Citation

Foral PA, Malesker MA, Huerta G, Hilleman DE. Nebulized opioids use in COPD. Chest. 2004 Feb;125(2):691-4. Review. — View Citation

Hildreth L, Pett D, Higgins E. Nebulized fentanyl for refractory dyspnea secondary to chronic obstructive pulmonary disease (COPD): A case report. Respir Med Case Rep. 2020 Oct 12;31:101251. doi: 10.1016/j.rmcr.2020.101251. eCollection 2020. — View Citation

Krajnik M, Jassem E, Sobanski P. Opioid receptor bronchial tree: current science. Curr Opin Support Palliat Care. 2014 Sep;8(3):191-9. doi: 10.1097/SPC.0000000000000072. Review. — View Citation

Scialo F, Daniele A, Amato F, Pastore L, Matera MG, Cazzola M, Castaldo G, Bianco A. ACE2: The Major Cell Entry Receptor for SARS-CoV-2. Lung. 2020 Dec;198(6):867-877. doi: 10.1007/s00408-020-00408-4. Epub 2020 Nov 10. Review. — View Citation

Uronis HE, Currow DC, Abernethy AP. Palliative management of refractory dyspnea in COPD. Int J Chron Obstruct Pulmon Dis. 2006;1(3):289-304. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breathlessness	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.	15-minutes post-treatment
Primary	Throat Pain	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'.	15-minutes post-treatment
Primary	Cough	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.	15-minutes post-treatment