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Nasal spray could replace needles for sickle cell pain emergencies

NCT ID NCT04076748

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a nasal spray containing a strong painkiller (sufentanil) for adults with sickle cell disease experiencing a painful crisis. The goal was to see if it could provide faster relief than the standard gas mixture (EMONO) before giving morphine through an IV. The trial was stopped early, so the full results are not available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sufentanil (a strong painkiller given as a nasal spray)
What this could lead to
If it worked, this could offer a faster, needle-free way to ease severe sickle cell pain in the emergency room.
What could go wrong
The trial was terminated early, so results are limited. It is unclear if the nasal spray works better than the standard gas treatment, and strong painkillers carry risks like drowsiness or breathing problems.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

115 people

The number who actually took part.

Started

Jul 2021

Finished

Jul 2024

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show 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 to 75 years old; * Sickle-cell patient. * Signs of a vaso-occlusive crisis (migratory bone pain, which may occur in the limbs, spine, thorax, pelvis, skull) or crisis known as such by the patient; * Severe pain (NRS ≥ 6/10) on admission to the ED; * Registered with the social security scheme or his beneficiaries (except AME) * Signature of free and informed consen. Exclusion Criteria: * Strong opioids received in the previous 6 hours; * Pregnancy or breastfeeding; * Woman not menopausal nor sterile without effective contraception (HAS criteria) * Oxygen saturation below 93%; * Patients who cannot cooperate because of a State of agitation or a Cognitive impairment * Unable to communicate; * Unable to do self-assessment; * Allergy or intolerance to opiates or nitrous oxide. * Abuse or addiction to opioids * Liver insufficiency * Renal insufficiency * Severe asthma or chronic obstructive bronchopulmonary disease * Pulmonary disease necessitating oxygen * Presence of seriousness signs: * All respiratory seriousness signs * all neurologic signs or consciousness impairment (coma Glasgow scale under 15) * hyperthermia over than 39°C * Signs of intolerance of acute anemia * Signs of hemodynamic failure * Known organ failure (renal insufficiency, pulmonary high blood pressure) * A description by the patient of a non usual crisis. * Current treatment with nasal vasoconstrictors is ongoing * Head injury with suspicion of high intracranial pressure * Severe thoracic trauma or decompensated respiratory insufficiency * Contraindications of intranasal administration: * Facial trauma * Nose or sinusal surgery in the previous 6 months before inclusion * Chronic nose and upper airway alteration (ex. facial malformation) * Acute nose and upper airway alteration (ex. Epistaxis, acute respiratory infection, sinusitis). * Contraindication to nitrous oxide * Contraindication to morphine * Patient's refusal to participate in the study. * Previous inclusion in the study of less than 14 days.

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Conditions

The condition(s) this trial relates to.

agnosia sickle cell disease Vaso-Occlusive Crises

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • CH de Cayenne

    Cayenne, 97306, French Guiana

  • CHU Pointe à Pitre

    Les Abymes, 97159, Guadeloupe

  • Gonesse Hospital

    Gonesse, 95500, France

  • Hopital Pellegrin

    Bordeaux, 33000, France

  • Hôpital Charles Nicolle

    Rouen, 76031, France

  • Hôpital Edouard Herriot

    Lyon, 69003, France

  • Hôpital Louis Mourier

    Colombes, 92700, France

  • Hôpital Rangueil

    Toulouse, 31059, France

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