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
|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Crisis||Drug: Sufentanil Drug: EMONO||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||196 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
* 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:
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
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. [ 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).
- 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.
- Morphine consumption (mg) [ Time Frame: from date of inclusion to 60 minutes after ]Assessed morphine consumption after treatment initiation, until 60 minutes.
- Morphine consumption (mg) [ Time Frame: from date of inclusion to 120 minutes after ]Assessed morphine consumption after treatment initiation, until 120 minutes.
- 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
- 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
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
|Contact: Michel GALINSKI, Pr||5 56 79 48 26 ext +email@example.com|
|Contact: Cedric GIL-JARDINE, Drfirstname.lastname@example.org|
|Bordeaux, France, 33000|
|Contact: Michel GALINSKI, Pr 5 56 79 48 26 ext +33 email@example.com|
|Sub-Investigator: Cedric GIl-JARDINE, Dr|
|Hôpital Louis Mourier||Not yet recruiting|
|Colombes, France, 92700|
|Contact: Nicolas JAVAUD firstname.lastname@example.org|
|Hôpital Edouard Herriot||Recruiting|
|Lyon, France, 69003|
|Contact: Jihane FATTOUM email@example.com|
|Hôpital Charles Nicolle||Not yet recruiting|
|Rouen, France, 76031|
|Contact: Luc-Marie JOLY firstname.lastname@example.org|
|Sub-Investigator: Virginie-Eve LVOVSCHI|
|Toulouse, France, 31059|
|Contact: Annie MOMO BONA email@example.com|
|CH de Cayenne||Recruiting|
|Cayenne, French Guiana, 97306|
|Contact: Narcisse ELENGA firstname.lastname@example.org|
|CHU Pointe à Pitre||Not yet recruiting|
|Les Abymes, Guadeloupe, 97159|
|Contact: Maryse ETIENNE-JULAN email@example.com|
|Study Chair:||Eric FRISON, Dr||USMR|