drugset / Trial / NCT04076748

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

NCT04076748

Phase 3 Terminated 115 enrolled University Hospital, Bordeaux
RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2021-07-20
Primary completion
2024-07-21
Completion
2024-07-21

Drugs

EvaluationDrugModalityDoseRoute
Comparator Equimolar Mixture of Oxygen-Nitrous Oxide Unknown Inhaled
Subject Sufentanil Other / unclassified 5 ug Intranasal

Indications