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Intranasal Sufentanil for Pediatric Sickle Cell Vaso-occlusive Crisis
NCT06181695Phase 3
Key facts
- Status
- Not yet recruiting
- Start
- May 2024
- Primary completion
- May 2026
- Sponsor
- Assistance publique - Hôpitaux de Paris
- Modality
- Orthosteric Ligands
- Drugs
- sufentanil
- Conditions
- sickle cell disease (SCD)
01
Overview
Phase 3, randomised, double-blind trial in sickle cell disease (SCD) comparing Sufentanil IN + Morphine IV with Placebo IN + Morphine IV (2 arms). Primary endpoint: Evaluation of the Efficacy of Intra-nasal Sufentanil for Analgesia of Vaso-occlusive Crisis at 30 months. Planned start May 2024; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Sufentanil IN + Morphine IV
Intranasal Sufentanil followed by IV Morphine
Placebo IN + Morphine IV
Intranasal Placebo followed by IV Morphine
03
Who it enrols
Children <18 years with Sickle Cell Disease presenting to ED with severe vaso-occlusive crisis pain (EVENDOL >= 10 or NRS >= 7). Excludes those with recent opioid use, respiratory failure, or severe organ dysfunction.
04
Endpoints
Primary
Evaluation of the Efficacy of Intra-nasal Sufentanil for Analgesia of Vaso-occlusive Crisis
Secondary
Proportion of children relieved (EVENDOL <= 5/15 or NRS-11 <= 3/10)
Proportion of children with a moderate pain (EVENDOL <= 9/15 or NRS-11 <= 6/10)
Decrease in the level of morphine consumption
Absence of increase rate of hemodynamic and non-hemodynamic side effects of opiace
Decrease the proportion of VOC complications
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