Could a fentanyl spray replace needles for emergency pain?
NCT ID NCT06281951
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage study tests two ways to give fentanyl without needles: a face mask and a nasal spray. Twenty healthy volunteers will receive small doses to see how well the drug enters the body. The goal is to find a faster, easier way to manage pain in emergency rooms without needing an IV.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fentanyl
- What this could lead to
- If successful, this could point toward a needle-free way to deliver fast pain relief in emergency rooms.
- What could go wrong
- This is a very early, small study in healthy people, not patients in pain. It only measures how the drug moves through the body, not whether it actually relieves pain effectively.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 68 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University Hospital, Rouen
RECRUITINGRouen, France, 76031, France
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Other studies related to the condition(s) this trial covers.
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