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

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).

Study point of contact

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

Locations

5 France sites

1 Guadeloupe site

1 French Guiana site

Age

18 to 75 Years

Phase

Phase 3

Study type

Interventional

Age

18 Years - 75 Years

Gender

All

Interventions

Drug

Compensation

Unknown

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 [Recruiting]
  • Colombes, France, Hôpital Louis Mourier, 92700 [Not yet recruiting]
  • Lyon, France, Hôpital Edouard Herriot, 69003 [Recruiting]
  • Rouen, France, Hôpital Charles Nicolle, 76031 [Not yet recruiting]
  • Toulouse, France, Hôpital Rangueil, 31059 [Recruiting]
  • Cayenne, French Guiana, CH de Cayenne, 97306 [Recruiting]
  • Les Abymes, Guadeloupe, CHU Pointe à Pitre, 97159 [Not yet recruiting]
Last updated 2021-11-19