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RECRUITING
NCT06281951
PHASE1

Nebulized Fentanyl in Healthy Volunteers

Sponsor: University Hospital, Rouen

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - 68 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2024-04-26

Completion Date

2026-09-01

Last Updated

2025-04-15

Healthy Volunteers

Yes

Interventions

DRUG

Fentanyl - 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).

DRUG

Fentanyl - 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