Nebulized Fentanyl in Healthy Volunteers
Nebulized Fentanyl in Healthy Volunteers : Comparison of Facial Versus Intranasal Aerosol Administration by Pharmacometric Modeling
University Hospital, Rouen
20 participants
Apr 26, 2024
INTERVENTIONAL
Conditions
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
Eligibility
Plain Language Summary
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Interventions
3 administrations based on a weight-dependent threshold (40 µg per administration for a weight \< 70kg and 50 µg per administration for a weight ≥ 70kg).
3 administrations based on a weight-dependent threshold (20 µg/administration and for a weight \< 70kg and 30 µg/administration for a weight ≥ 70kg). The dose of each bolus will be distributed at equivalent volume in both nasal pits
Locations(1)
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NCT06281951