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

Study point of contact

Cedric GIL-JARDINE, Dr
[email protected]
Michel GALINSKI, Pr
5 56 79 48 26 ext +33
[email protected]

Locations

6 France sites

1 Guadeloupe site

1 French Guiana site

Age

18 to 75 Years

Phase

Phase 3

Study type

Interventional

Gender

All

Interventions

Drug

Compensation

Unknown

About the 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).

participation requirements

– 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.

participation restrictions

– 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.

Locations

  • Bordeaux, France, Hopital Pellegrin, 33000
  • Colombes, France, Hôpital Louis Mourier, 92700
  • Lyon, France, Hôpital Edouard Herriot, 69003
  • Paris, France, Hôpital Tenon, 75020
  • Rouen, France, Hôpital Charles Nicolle, 76031
  • Toulouse, France, Hôpital Rangueil, 31059
  • Cayenne, French Guiana, CH de Cayenne, 97306
  • Les Abymes, Guadeloupe, CHU Pointe à Pitre, 97159