Phase
Condition
Sickle Cell Disease
Treatment
Sufentanil
EMONO
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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.
Exclusion
Exclusion Criteria:
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 Cognitiveimpairment
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 respiratoryinfection, 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.
Study Design
Study Description
Connect with a study center
Hopital Pellegrin
Bordeaux, 33000
FranceSite Not Available
Hôpital Louis Mourier
Colombes, 92700
FranceSite Not Available
Gonesse Hospital
Gonesse, 95500
FranceSite Not Available
Hôpital Edouard Herriot
Lyon, 69003
FranceSite Not Available
Hôpital Charles Nicolle
Rouen, 76031
FranceSite Not Available
Hôpital Rangueil
Toulouse, 31059
FranceSite Not Available
CH de Cayenne
Cayenne, 97306
French GuianaSite Not Available
CHU Pointe à Pitre
Les Abymes, 97159
GuadeloupeSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.