Evaluation of the Efficacy of Intra-nasal Sufentanil for Analgesia of Vaso-occlusive Crisis in Si… (NCT04076748) | Clinical Trial Compass
TerminatedPhase 3
Evaluation of the Efficacy of Intra-nasal Sufentanil for Analgesia of Vaso-occlusive Crisis in Sickle-cell Adults.
Stopped: Target number of inclusion not reached
France, French Guiana, Guadeloupe115 participantsStarted 2021-07-20
Plain-language summary
The analgesic treatment for vaso-occlusive crisis (VOC) in sickle-cell patients is an emergency. The reference treatment is morphine, which requires a venous way sometimes difficult to obtain in these patients. Sufentanil intranasal has been shown to be effective in traumatology. The objective is to evaluate, in VOC, the efficacy of intranasal sufentanil relayed by morphine IV compared to the usual protocol, Equimolar Mixture of Oxygen-Nitrous Oxide (EMONO) relayed by morphine intravenous (IV).
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 p…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients relieved (NRS ≤ 3/10) 30 minutes after starting treatment in each group.
Timeframe: From date of inclusion to 30 minutes after