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Evaluation of the Efficacy of Intra-nasal Sufentanil for Analgesia of Vaso-occlusive Crisis in Sickle-cell Adults. (DREPSUFINDOL)

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ClinicalTrials.gov Identifier: NCT04076748
Recruitment Status : Recruiting
First Posted : September 3, 2019
Last Update Posted : November 22, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief 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).

Condition or disease Intervention/treatment Phase
Sickle Cell Crisis Drug: Sufentanil Drug: EMONO Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of Intra-nasal Sufentanil for Analgesia of Vaso-occlusive Crisis in Sickle-cell Adults.
Actual Study Start Date : July 20, 2021
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Sufentanil
The intervention is intranasal Sufentanil adminstration, then IV morphine as soon as possible.

Active Comparator: Control

* 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
In the control group, patients will receive EMONO then IV morphine as soon as possible.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Adverse events occuring until 4 hours after treatment initiation. [ Time Frame: From date of inclusion to 4 hours after ]
    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.

  2. Morphine consumption (mg) [ Time Frame: from date of inclusion to 60 minutes after ]
    Assessed morphine consumption after treatment initiation, until 60 minutes.

  3. Morphine consumption (mg) [ Time Frame: from date of inclusion to 120 minutes after ]
    Assessed morphine consumption after treatment initiation, until 120 minutes.

  4. Time to obtain an effective analgesia [ Time Frame: through study completion, an average of 4 hours ]
    Defined an average time to obtain an effective analgesia, after treatment initiation

  5. Time to obtain a venous access [ Time Frame: through study completion, an average of 4 hours ]
    Defined an average time to obtain a venous access, after treatment initiation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04076748


Contacts
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Contact: Michel GALINSKI, Pr 5 56 79 48 26 ext +33 michel.galinski@chu-bordeaux.fr
Contact: Cedric GIL-JARDINE, Dr cedric.gil-jardine@chu-bordeaux.fr

Locations
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France
Hopital Pellegrin Recruiting
Bordeaux, France, 33000
Contact: Michel GALINSKI, Pr    5 56 79 48 26 ext +33    michel.galinski@chu-bordeaux.fr   
Sub-Investigator: Cedric GIl-JARDINE, Dr         
Hôpital Louis Mourier Not yet recruiting
Colombes, France, 92700
Contact: Nicolas JAVAUD       nicolas.javaud@aphp.fr   
Hôpital Edouard Herriot Recruiting
Lyon, France, 69003
Contact: Jihane FATTOUM       jihane.fattoum-lamouchi@chu-lyon.fr   
Hôpital Charles Nicolle Not yet recruiting
Rouen, France, 76031
Contact: Luc-Marie JOLY       luc-marie.joly@chu-rouen.fr   
Sub-Investigator: Virginie-Eve LVOVSCHI         
Hôpital Rangueil Recruiting
Toulouse, France, 31059
Contact: Annie MOMO BONA       momobona.a@chu-toulouse.fr   
French Guiana
CH de Cayenne Recruiting
Cayenne, French Guiana, 97306
Contact: Narcisse ELENGA       narcisse.elenga@ch-cayenne.fr   
Guadeloupe
CHU Pointe à Pitre Not yet recruiting
Les Abymes, Guadeloupe, 97159
Contact: Maryse ETIENNE-JULAN       maryse.etienne-julan@chu-guadeloupe.fr   
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Study Chair: Eric FRISON, Dr USMR
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT04076748    
Other Study ID Numbers: CHUBX 2017/46
First Posted: September 3, 2019    Key Record Dates
Last Update Posted: November 22, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
analgesia
vaso-occlusive crisis
sufentanil
intra-nasal
Additional relevant MeSH terms:
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Sufentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics