Nasal spray could replace needles for sickle cell pain emergencies
NCT ID NCT04076748
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
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Jul 2021
- Finished
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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
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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 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 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.
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
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CHU Pointe à Pitre
Les Abymes, 97159, Guadeloupe
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Gonesse Hospital
Gonesse, 95500, France
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Hopital Pellegrin
Bordeaux, 33000, France
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Hôpital Charles Nicolle
Rouen, 76031, France
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Hôpital Edouard Herriot
Lyon, 69003, France
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Hôpital Louis Mourier
Colombes, 92700, France
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Hôpital Rangueil
Toulouse, 31059, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can adding common pain drugs reduce morphine needs in sickle cell crises?
- Gene editing offers hope for a One-Time sickle cell cure
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- Can a milder transplant cure sickle cell and thalassemia in adults?
- Can an antioxidant supplement calm sickle cell blood cells?