Last updated: March 6, 2023
Sponsor: University Hospital, Bordeaux
Overall Status: Active - Recruiting
Phase
3
Condition
Sickle Cell Disease
Treatment
N/AClinical Study ID
NCT04076748
CHUBX 2017/46
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
Total Participants: 196
Study Start date:
July 20, 2021
Estimated Completion Date:
January 31, 2024
Study Description
Connect with a study center
Hopital Pellegrin
Bordeaux, 33000
FranceActive - Recruiting
Hôpital Louis Mourier
Colombes, 92700
FranceSite Not Available
Gonesse Hospital
Gonesse, 95500
FranceActive - Recruiting
Hôpital Edouard Herriot
Lyon, 69003
FranceActive - Recruiting
Hôpital Tenon
Paris, 75020
FranceSite Not Available
Hôpital Charles Nicolle
Rouen, 76031
FranceSite Not Available
Hôpital Rangueil
Toulouse, 31059
FranceActive - Recruiting
CH de Cayenne
Cayenne, 97306
French GuianaActive - Recruiting
CHU Pointe à Pitre
Les Abymes, 97159
GuadeloupeSite Not Available
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