Status:
UNKNOWN
Evaluation of the Efficacy of Intra-nasal Sufentanil for Analgesia of Vaso-occlusive Crisis in Sickle-cell Adults.
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Sickle Cell Crisis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
Pain of VOC in sickle-cell patients seen in the emergency department (ED) is severe. Analgesia is a therapeutic emergency based on intravenous (IV) morphine titration. However, for technical reasons (...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2024
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT04076748
Start Date
July 20 2021
End Date
January 1 2024
Last Update
March 7 2023
Active Locations (8)
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1
Hopital Pellegrin
Bordeaux, France, 33000
2
Hôpital Louis Mourier
Colombes, France, 92700
3
Gonesse Hospital
Gonesse, France, 95500
4
Hôpital Edouard Herriot
Lyon, France, 69003