Nebulized Fentanyl for Pain Relief in Healthy Adults
Nebulized Fentanyl in Healthy Volunteers : Comparison of Facial Versus Intranasal Aerosol Administration by Pharmacometric Modeling
This study tests if using a nebulizer to deliver fentanyl can safely and comfortably relieve pain in healthy adults without needing needles.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 68 Years |
| Sex | All |
| Sponsor | University Hospital, Rouen Academic / other |
| Locations | 1 site (Rouen, France) |
| Trial ID | NCT06281951 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility and comfort of administering nebulized fentanyl for pain relief in healthy volunteers. It focuses on non-invasive methods of analgesia, particularly through intranasal and facial aerosol delivery, to avoid the complications associated with intravenous administration. The study employs pharmacokinetic and pharmacodynamic assessments to understand the effectiveness and safety of this approach in emergency medicine settings.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18 to 68 with a BMI between 19 and 29 kg/m².
Not a fit: Patients who are not healthy or those with contraindications to opioid use may not benefit from this study.
Why it matters
Potential benefit: If successful, this method could provide a rapid and effective pain relief option for patients in emergency situations without the need for intravenous access.
How similar studies have performed: While nebulized opioid administration is a novel approach, similar studies have shown promise in non-invasive pain management techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 hormonal contraception (containing estrogens and progestins) associated with inhibition of ovulation, progestin-only hormonal contraception associated with inhibition of ovulation, intrauterine device, hormone-releasing intrauterine system (IUS), bilateral tubal occlusion, vasectomized partner, sexual abstinence) for 1 year and a negative urine pregnancy test at inclusion and during the duration of the study. * 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 medical cause. Exclusion Criteria: * 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
Where this trial is running
Rouen, France
- University Hospital, Rouen — Rouen, France, France (Recruiting)
Study contacts
- Study coordinator: Cassandre Follet
- Email: cassandre.follet@chu-rouen.fr
- Phone: +33232888990
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.