RecruitingPhase 1NCT06281951

Nebulized Fentanyl in Healthy Volunteers

Nebulized Fentanyl in Healthy Volunteers : Comparison of Facial Versus Intranasal Aerosol Administration by Pharmacometric Modeling


Sponsor

University Hospital, Rouen

Enrollment

20 participants

Start Date

Apr 26, 2024

Study Type

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

Min Age: 18 YearsMax Age: 68 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Fentanyl - Inhalation by facial nebulization and a drug called Fentanyl - Nebulisation for people with analgesia and emergencies. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 68 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFentanyl - Inhalation by facial nebulization

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).

DRUGFentanyl - Nebulisation

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)

University Hospital, Rouen

Rouen, France, France

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NCT06281951


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