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New treatment option for Analgesia
Official title Nebulized Fentanyl in Healthy Volunteers
ClinicalTrials.gov ID: NCT06281951
What this study is testing
What is Fentanyl - Inhalation by facial nebulization?
Fentanyl - Inhalation by facial nebulization is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for analgesia.
Also referred to as AEROGEN Nebulizer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 68. Healthy volunteers may be eligible.
You may be able to join if
- Age ≥ 18 years and \< 68 years
- BMI between 19 and 29 kg/m²
- Affiliation to a social security scheme
- Adult who has read and understood the information letter and signed the consent form
- Woman capable of procreating (a woman is considered capable of procreating, i.e. fertile, after menarche and until she becomes menopausal, unless she...
You likely can't join if
- Weight \< 50 kg
- Taking long-term painkillers or narcotics
- Sharp pain
- Stable chronic pain (\>3 months, with or without long-term treatment)
- Known chronic pathology stabilized or decompensated (hypertension, renal, cardiac, hepatic insufficiency, etc.)
- Stable or decompensated chronic respiratory pathology
See the full eligibility criteria
- Age ≥ 18 years and \< 68 years
- BMI between 19 and 29 kg/m²
- Affiliation to a social security scheme
- Adult who has read and understood the information letter and signed the consent form
- Woman capable of procreating (a woman is considered capable of procreating, i.e. fertile, after menarche and until she becomes menopausal, unless she is definitely sterile ) having very effective contraception (combined...
- Woman definitely surgically sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy). Postmenopausal woman: The postmenopausal state is defined by the absence of periods for 12 months without any other...
- Weight \< 50 kg
- Taking long-term painkillers or narcotics
- Sharp pain
- Stable chronic pain (\>3 months, with or without long-term treatment)
- Known chronic pathology stabilized or decompensated (hypertension, renal, cardiac, hepatic insufficiency, etc.)
- Stable or decompensated chronic respiratory pathology
- Chronic neuropsychiatric pathology likely to modify the pain threshold
- Long-term treatment with an action on the nervous system such as respiratory depression: benzodiazepines, neuroleptics, agonist/antagonist of the opioid system
- Treatment or toxicant whose association is not recommended with fentanyl (alcohol, cannabis, etc.)
- Central nervous system modulator treatment
- Pathologies blocking the pupillary response: Claude-Bernard-Horner syndrome, Adie syndrome, Argyll-Robertson pupil, senile miosis, dysautonomic neuropathy (advanced diabetes, systemic amyloidosis), cataract
- Treatment responsible for fluctuation in PUAL measurements: parasympathetic modulators (clonidine, dexmedetomidine, droperidol, metoclopramide)
- No-indication to FENTANYL PIRAMAL 100µg/2mL, solution for injection in ampoule
- No-indication to PROAMP SODIUM CHLORIDE 0.9%, solution for injection
- Ongoing treatment with nasal vasoconstrictors
- Peripheral oxygen saturation less than 93%
- Alteration of cognitive state: comprehension disorder, language disorder, memory disorder, confusion
- Deaf or mute patient
- Usual heart rate such as HR\< 40 bpm and/or hypotension with systolic blood pressure SBP\< 100 mm Hg
- Atrioventricular block on ECG
- History of cataract surgery
- Confirmed or suspected covid 19 / active flu infection less than 15 days old
- Allergy to plastic
- Pregnant or parturient or breastfeeding woman or proven absence of contraception
- Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection/under guardianship or curatorship
- Person participating in research participating in another trial / having participated in another trial within 2 weeks
- History of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol or preventing them from giving informed consent
The study team makes the final eligibility decision.
Where it's taking place
- Rouen, France, France
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 68 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rouen, France, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.