Actively Recruiting
Nebulized Fentanyl in Healthy Volunteers
Led by University Hospital, Rouen · Updated on 2026-05-11
20
Participants Needed
1
Research Sites
161 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Nebulized Fentanyl in Healthy Volunteers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years and older but less than 68 years
- Body mass index (BMI) between 19 and 29 kg/m²
- Affiliated with a social security scheme
- Adult who has read and understood the information and signed consent
- Women capable of procreating must use very effective contraception for 1 year and have a negative pregnancy test at inclusion and during the study
- Women who are surgically sterile or postmenopausal (no periods for 12 months without other medical cause)
You will not qualify if you...
- Weight less than 50 kg
- Taking long-term painkillers or narcotics
- Experiencing sharp pain
- Having stable chronic pain for more than 3 months
- Known chronic diseases (hypertension, kidney, heart, liver issues) either stable or decompensated
- Stable or decompensated chronic respiratory disease
- Chronic neuropsychiatric conditions affecting pain threshold
- Long-term treatments affecting the nervous system like benzodiazepines, neuroleptics, or opioid agonists/antagonists
- Use of alcohol, cannabis, or substances not recommended with fentanyl
- Treatments altering pupillary response or PUAL measurements
- No indication for fentanyl or sodium chloride injection solutions
- Using nasal vasoconstrictors
- Oxygen saturation below 93%
- Cognitive impairments like comprehension or memory disorders
- Deafness or muteness
- Heart rate below 40 bpm or low blood pressure (systolic under 100 mm Hg)
- Atrioventricular block on ECG
- History of cataract surgery
- Recent COVID-19 or flu infection within 15 days
- Allergy to plastic
- Pregnant, breastfeeding, or lacking contraception
- Legal restrictions on liberty or guardianship
- Participation in another clinical trial within 2 weeks
- Psychological or sensory conditions preventing informed consent or full participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospital, Rouen
Rouen, France, France, 76031
Actively Recruiting
Research Team
C
Cassandre Follet
CONTACT
F
Florian Vallin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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