Sickle Cell CrisisPhase 3DREPSUFINDOLNCT04076748
Evaluation of the Efficacy of Intra-nasal Sufentanil for Analgesia of Vaso-occlusive Crisis in Sickle-cell Adults.
A Phase 3 study testing Sufentanil and EMONO in people with Sickle Cell Crisis, run by University Hospital, Bordeaux at 8 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sickle Cell Crisis
- What is being tested?
- Sufentanil and EMONO
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 20 Jul 2021to 21 Jul 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
France6 sites
Hopital Pellegrin
Bordeaux, 33000
Hôpital Louis Mourier
Colombes, 92700
Gonesse Hospital
Gonesse, 95500
Hôpital Edouard Herriot
Lyon, 69003
Hôpital Charles Nicolle
Rouen, 76031
Hôpital Rangueil
Toulouse, 31059
About this study
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).
Read the detailed description
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.
- Conditions
- Sickle Cell Crisis
- Being tested
- Sufentanil, EMONO
- Keywords
- analgesia, vaso-occlusive crisis, sufentanil, intra-nasal
- Medical subject headings
- Vaso-Occlusive Crises, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SufentanilDrug
The intervention is intranasal Sufentanil adminstration, then IV morphine as soon as possible.
EMONODrug
In the control group, patients will receive EMONO then IV morphine as soon as possible.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | * 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. Receives: Drug: Sufentanil |
| Control | Active comparator | * 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 Receives: Drug: EMONO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From date of inclusion to 30 minutes after
Secondary outcomes (5)
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.
Measured: From date of inclusion to 4 hours after
Morphine consumption (mg)
Assessed morphine consumption after treatment initiation, until 60 minutes.
Measured: from date of inclusion to 60 minutes after
Morphine consumption (mg)
Assessed morphine consumption after treatment initiation, until 120 minutes.
Measured: 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
Measured: 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
Measured: through study completion, an average of 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2019
- Study start20 Jul 2021
- Primary completion21 Jul 2024
- Study completion21 Jul 2024
Why it stopped: Target number of inclusion not reached
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell CrisisStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric FRISON, Dr, Study chair, USMR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04076748
- Sponsor's protocol ID
- CHUBX 2017/46
- Other IDs
- 2019-001274-29, 2019
- Acronym
- DREPSUFINDOL
- Status last verified
- Jun 2026
- First submitted
- 30 Aug 2019
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Intra-nasal Sufentanil for Analgesia of Vaso-occlusive Crisis in Sickle-cell Adults.
- ClinicalTrials.gov ID
- NCT04076748
- Acronym / sponsor ID
- DREPSUFINDOL / CHUBX 2017/46
- Conditions
- Sickle Cell Crisis
- Keywords
- analgesia, vaso-occlusive crisis, sufentanil, intra-nasal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Target number of inclusion not reached
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 21 Jul 2024 (actual)
- Study completion
- 21 Jul 2024 (actual)
- First posted
- 3 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Sufentanil* 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. |
| Control | Active comparator | Drug: EMONO* 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (33 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SufentanilThe intervention is intranasal Sufentanil adminstration, then IV morphine as soon as possible. | Drug | Experimental |
| EMONOIn the control group, patients will receive EMONO then IV morphine as soon as possible. | Drug | Control |
Primary outcome
Proportion of patients relieved (NRS ≤ 3/10) 30 minutes after starting treatment in each group.
Time frame: From date of inclusion to 30 minutes after
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).
5 secondary outcomes
Adverse events occuring until 4 hours after treatment initiation.
Time frame: From date of inclusion to 4 hours after
Morphine consumption (mg)
Time frame: from date of inclusion to 60 minutes after
Morphine consumption (mg)
Time frame: from date of inclusion to 120 minutes after
Time to obtain an effective analgesia
Time frame: through study completion, an average of 4 hours
Time to obtain a venous access
Time frame: through study completion, an average of 4 hours
Results and safety
The study was stopped early (reason given: Target number of inclusion not reached). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric FRISON, Dr study chair
USMR
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sufentanil and EMONO in people with Sickle Cell Crisis, run by University Hospital, Bordeaux at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France, French Guiana, Guadeloupe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Target number of inclusion not reached). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients relieved (NRS ≤ 3/10) 30 minutes after starting treatment in each group. (time frame: From date of inclusion to 30 minutes after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.