A Phase 3 interventional study of Sufentanil and EMONO in Sickle Cell Crisis, sponsored by University Hospital, Bordeaux. Terminated at 8 sites in 3 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by University Hospital, Bordeaux · Phase 3, Interventional, and Treatment
Among 26 studies in Vaso-Occlusive Crises with a site in France — 9 open to participants now, 12 under way, 5 of them phase 3. Vaso-Occlusive Crises · France.
Among the 26 studies in Vaso-Occlusive Crises with a site in France, this one is the 7th largest by enrollment of the 23 interventional ones, is one of 7 that started in 2021, is one of 8 in phase 3, and was the 10th registered.
104 studies on the registry are indexed under Vaso-Occlusive Crises; 31 are open to participants now.
This study's enrollment of 115 is above the median of 81 across 86 interventional studies indexed under Vaso-Occlusive Crises.
Browse Vaso-Occlusive Crises studies →9 of the 26 studies in Vaso-Occlusive Crises with a site in France are open now, in 12 countries. Each count lists the studies.
Of the 17 Vaso-Occlusive Crises studies recruiting now, 7 (41%) set no upper age limit and 6 (35%) stop at 75 or younger; 10 take children under 18; 1 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →26 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 7 started in 2021.
Median enrollment 97 across the 23 interventional studies, 200 across the 3 observational. Of the 11 that completed or were terminated, 2 (18%) have results posted.
8 of 26 have an industry lead sponsor. The 10 most frequent:
University Hospital, Bordeaux is the lead sponsor of 806 studies on the registry; 197 are open to participants now.
University Hospital, Bordeaux has 1 study filed under Vaso-Occlusive Crises — fewer than ten, so there is no comparison to draw.
1 of the studies in Vaso-Occlusive Crises with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05646888University Hospital, ToulouseInflammation, Platelets and Sickle Cell Disease | 2026-11-30 |
Among the 26 studies in Vaso-Occlusive Crises with a site in France, from their registry updates:
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).
Pain of VOC in sickle-cell patients seen in the emergency department (ED) is severe. Analgesia is a therapeutic emergency based on intravenous (IV) morphine titration. However, for technical reasons (patient flow in ED, difficult venous access) this treatment is often delayed. The Equimolar Mixture of Oxygen-Nitrous Oxide (EMONO), an inhaled analgesic administered, makes it possible to temporarily and very partially compensate for the major analgesic defect. Its efficacy in this indication has never been demonstrated; it is less effective than opiates during labour and is associated with a risk of addiction. The intranasal (IN) route is used to administer strong opiates such as sufentanil. Sufentanil IN has been shown to be rapidly effective in traumatology. Its duration of action is similar to that of morphine IV but its duration of action is far too short to completely replace it. Its ideal place would therefore be the initial phase of the management while waiting for a venous approach.
The strategy is to propose an intranasal administration of an opioid (Sufentanil) at the initial management of vaso-occlusive crisis in sickle-cell patients in the ED waiting to a venous route for morphine.
Follow-up of the study will be carried out in the ED with numeric rating scale (NRS) measurement every 5 minutes until patient relief (defined by NRS ≤ 3/10). Once relieved, NRS will be measured every 15 minutes for at least 2 hours. Treatment-related side effects will be systematically investigated up to 4 hours after starting treatment. In particular, the respiratory rate and level of consciousness will be measured, and all side effects will be recorded: nausea, vomiting, dizziness, behavioural disorders, pruritus.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Presence of seriousness signs:
of intranasal administration:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
\* Intra Nasal Sufentanil (50 µg.ml-1): Load dose : 0.3 µg. kg-1, Followed by bolus : 5 µg / 10 minutes with 2 bolus maximum. As soon as the venous route and ten minutes after the last administration of sufentanil: * Morphine IV: 3 mg / 5 minutes. * Objective: numeric rating scale (NRS) ≤ 3/10.
Drug: Sufentanil
\* EMONO : Given by respiratory administration via a face mask at a rate suitable for patient ventilation (generally at least 9l.min-1), Until a venous route is obtained and without exceeding 30 minutes. \* Morphine IV: Load dose: 0.1mg. kg-1 as soon as possible; Then bolus: 3mg / 5 minutes. \* Objective: NRS ≤ 3/10
Drug: EMONO
The intervention is intranasal Sufentanil adminstration, then IV morphine as soon as possible.
In the control group, patients will receive EMONO then IV morphine as soon as possible.
Proportion of patients relieved (NRS ≤ 3/10) 30 minutes after starting treatment in each group.
This proportion is measured thanks to a numeric rating scale (NRS). The scale define pain intensity, range between 0 and 10, 10 being the worst pain imaginable and 0 the absence of pain. The NRS is measured every 5 minutes until patient relief (defined by NRS ≤ 3/10).
Time frame: From date of inclusion to 30 minutes after
Adverse events occuring until 4 hours after treatment initiation.
This outcome is defined by the proportion of patients with at least one adverse events during the medical care, until 4 hours after treatment initiation.
Time frame: From date of inclusion to 4 hours after
Morphine consumption (mg)
Assessed morphine consumption after treatment initiation, until 60 minutes.
Time frame: from date of inclusion to 60 minutes after
Morphine consumption (mg)
Assessed morphine consumption after treatment initiation, until 120 minutes.
Time frame: from date of inclusion to 120 minutes after
Time to obtain an effective analgesia
Defined an average time to obtain an effective analgesia, after treatment initiation
Time frame: through study completion, an average of 4 hours
Time to obtain a venous access
Defined an average time to obtain a venous access, after treatment initiation
Time frame: through study completion, an average of 4 hours
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2021 to primary completion in Jul 2024, 36 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sufentanil
University Hospital, Bordeaux →