Nebulized Fentanyl in Healthy Volunteers

Summary

Pain constitutes the predominant motive prompting individuals to seek emergency medical attention, accounting for 80% of admissions to emergency departments. Presently, it is imperative to employ expeditious and efficacious analgesia-sedation methodologies, obviating the necessity for intravenous administration, while ensuring the secure delivery of pharmaceutical agents. The objective of this study is to assess the feasibility and comfort of nebulized intranasal or facial aerosol administration of Fentanyl through the implementation of a pharmacokinetic/pharmacodynamic (PK/PD) study

Timeline

Start

2024-04-26

Primary completion

2027-06-01

Completion

2027-06-01

Publications

• Background Barksdale AN, Hackman JL, Williams K, Gratton MC. ED triage pain protocol reduces time to receiving analgesics in patients with painful conditions. Am J Emerg Med. 2016 Dec;34(12):2362-2366. doi: 10.1016/j.ajem.2016.08.051. Epub 2016 Aug 27.
• Background Gueant S, Taleb A, Borel-Kuhner J, Cauterman M, Raphael M, Nathan G, Ricard-Hibon A. Quality of pain management in the emergency department: results of a multicentre prospective study. Eur J Anaesthesiol. 2011 Feb;28(2):97-105. doi: 10.1097/EJA.0b013e3283418fb0.
• Background Lvovschi V, Aubrun F, Bonnet P, Bouchara A, Bendahou M, Humbert B, Hausfater P, Riou B. Intravenous morphine titration to treat severe pain in the ED. Am J Emerg Med. 2008 Jul;26(6):676-82. doi: 10.1016/j.ajem.2007.10.025.
• Background Galinski M, Robledo JB, Tellier E, Catoire P, De La Riviere C, Lvovschi V, Gil-Jardine C. Are Patients with Chronic Pain Less Satisfied with Their ED Management Than Non-Chronic Pain Patients? Am J Emerg Med. 2022 Jun;56:7-9. doi: 10.1016/j.ajem.2022.03.032. Epub 2022 Mar 19. No abstract available.
• Background Mudd S. Intranasal fentanyl for pain management in children: a systematic review of the literature. J Pediatr Health Care. 2011 Sep-Oct;25(5):316-22. doi: 10.1016/j.pedhc.2010.04.011. Epub 2010 Jun 17.
• Background Adelgais KM, Brent A, Wathen J, Tong S, Massanari D, Deakyne S, Sills MR. Intranasal Fentanyl and Quality of Pediatric Acute Care. J Emerg Med. 2017 Nov;53(5):607-615.e2. doi: 10.1016/j.jemermed.2017.05.027. Epub 2017 Sep 28.
• Background Hudson RJ, Thomson IR, Henderson BT, Singh K, Harding G, Peterson DJ. Validation of fentanyl pharmacokinetics in patients undergoing coronary artery bypass grafting. Can J Anaesth. 2002 Apr;49(4):388-92. doi: 10.1007/BF03017328.
• Follet C, Dumont A, Roussel M, Gillibert A, Boedard C, Quillard M, Ruault S, Vallin F, Donnadieu N, Nunes Ferreira D, Pereira T, Joly LM, Lvovschi V, Duflot T. AEROfen: protocol for a phase I, open-label, randomised crossover study evaluating the efficiency of nebulised fentanyl in healthy volunteers - comparing facial versus intranasal administration via pharmacometric modelling. BMJ Open. 2025 Jul 3;15(7):e091125. doi: 10.1136/bmjopen-2024-091125.

Drugs

Indications

No indication recorded.