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).
| Michel GALINSKI, Pr | |
| 5 56 79 48 26 | |
| [email protected] |
| Cedric GIL-JARDINE, Dr | |
| [email protected] |
18 Years - 75 Years
Phase 3
Interventional
All
Drug
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.
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.
Previous inclusion in the study of less than 14 days.