[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100537755":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":34,"locations":46,"responsibleParty":59,"collaborators":33,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":33,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":48,"whyStopped":33,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"University Hospital, Rouen","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Facial Nebulization","EXPERIMENTAL","Fentanyl's facial nebulization in healthy volunteers.",[13],"Drug: Fentanyl - Inhalation by facial nebulization",{"label":15,"type":10,"description":16,"interventionNames":17},"Intranasal","Fentanyl's intranasal inhalation in healthy volunteers.",[18],"Drug: Fentanyl - Nebulisation",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Fentanyl - Inhalation by facial nebulization","3 administrations based on a weight-dependent threshold (40 µg per administration for a weight \\\u003C 70kg and 50 µg per administration for a weight ≥ 70kg).",[9],[26],"AEROGEN Nebulizer",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Fentanyl - Nebulisation","3 administrations based on a weight-dependent threshold (20 µg\u002Fadministration and for a weight \\\u003C 70kg and 30 µg\u002Fadministration for a weight ≥ 70kg). The dose of each bolus will be distributed at equivalent volume in both nasal pits",[15],[32],"Teleflex intranasal device",null,[35,41],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Cassandre Follet","CONTACT","+33232888990","60451","cassandre.follet@chu-rouen.fr",{"name":42,"role":37,"phone":43,"phoneExt":44,"email":45},"Florian Vallin","+3323288","6697","florian.vallin@chu-rouen.fr",[47],{"facility":5,"status":48,"city":49,"state":50,"zip":51,"country":50,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":33},"RECRUITING","Rouen","France","76031","FR",{"type":54,"coordinates":55},"Point",[56,57],1.09932,49.44313,{"lat":57,"lon":56},{"type":60,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100537755","phase-1-nebulized-fentanyl-in-healthy-volunteers-100537755",false,"NCT06281951","Nebulized Fentanyl in Healthy Volunteers","Nebulized Fentanyl in Healthy Volunteers : Comparison of Facial Versus Intranasal Aerosol Administration by Pharmacometric Modeling","AEROfen","Inclusion Criteria:\n\n* Age ≥ 18 years and \\\u003C 68 years\n* BMI between 19 and 29 kg\u002Fm²\n* Affiliation to a social security scheme\n* Adult who has read and understood the information letter and signed the consent form\n* 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.\n* 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.\n\nExclusion Criteria:\n\n* Weight \\\u003C 50 kg\n* Taking long-term painkillers or narcotics\n* Sharp pain\n* Stable chronic pain (\\>3 months, with or without long-term treatment)\n* Known chronic pathology stabilized or decompensated (hypertension, renal, cardiac, hepatic insufficiency, etc.)\n* Stable or decompensated chronic respiratory pathology\n* Chronic neuropsychiatric pathology likely to modify the pain threshold\n* Long-term treatment with an action on the nervous system such as respiratory depression: benzodiazepines, neuroleptics, agonist\u002Fantagonist of the opioid system\n* Treatment or toxicant whose association is not recommended with fentanyl (alcohol, cannabis, etc.)\n* Central nervous system modulator treatment\n* Pathologies blocking the pupillary response: Claude-Bernard-Horner syndrome, Adie syndrome, Argyll-Robertson pupil, senile miosis, dysautonomic neuropathy (advanced diabetes, systemic amyloidosis), cataract\n* Treatment responsible for fluctuation in PUAL measurements: parasympathetic modulators (clonidine, dexmedetomidine, droperidol, metoclopramide)\n* No-indication to FENTANYL PIRAMAL 100µg\u002F2mL, solution for injection in ampoule\n* No-indication to PROAMP SODIUM CHLORIDE 0.9%, solution for injection\n* Ongoing treatment with nasal vasoconstrictors\n* Peripheral oxygen saturation less than 93%\n* Alteration of cognitive state: comprehension disorder, language disorder, memory disorder, confusion\n* Deaf or mute patient\n* Usual heart rate such as HR\\\u003C 40 bpm and\u002For hypotension with systolic blood pressure SBP\\\u003C 100 mm Hg\n* Atrioventricular block on ECG\n* History of cataract surgery\n* Confirmed or suspected covid 19 \u002F active flu infection less than 15 days old\n* Allergy to plastic\n* Pregnant or parturient or breastfeeding woman or proven absence of contraception\n* Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection\u002Funder guardianship or curatorship\n* Person participating in research participating in another trial \u002F having participated in another trial within 2 weeks\n* 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",true,"ALL","18 Years","68 Years",{"count":74,"type":75},20,"ESTIMATED","INTERVENTIONAL",[78],"PHASE1","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\u002Fpharmacodynamic (PK\u002FPD) study",[81,82],"Analgesia","Emergencies",[84,85,86,87,88,89],"Severe acute pain","Pharmacometry","Fentanyl","Emergency medicine","Pupillometry (PUAL)","Non-invasive analgesia (Intranasal, Facial aerosol)","2026-05-06",{"date":92,"type":93},"2026-05-11","ACTUAL",{"date":95,"type":93},"2024-04-26",{"date":97,"type":75},"2027-06-01",{"name":5,"class":6},1]