Analgesia of vaso-occlusive crisis in sickle-cell adults
Conditions
Interventions
Product Name: Sufentanil IN
Pharmaceutical Form: Inhalation vapour, liquid
INN or Proposed INN: SUFENTANIL
CAS Number: 56030-54-7
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type:
Sponsors
CHU de Bordeaux
Eligibility
Sex/Gender
All
Inclusion criteria
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; Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 196 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 196
Exclusion criteria
Exclusion criteria: - Strong opioids received in the previous 6 hours; - Pregnancy or breastfeeding; - Oxygen saturation below 93%; - Patients who cannot cooperate because of a State of agitation or a Cognitive impairment - 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 - Contraindication to nitrous oxide - Contraindication to morphine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to assess efficacy of intranasal sufentanil relayed by morphine IV, compared to usual protocol, Equimolar Mixture of Oxygen-Nitrous Oxide, relayed by morphine IV, in vaso-occlusive crisis in sickle cell disease.;Secondary Objective: Compare between both treatment groups: •Side events occurring during management up to 4 hours after initiation of treatment •Proportion of patients relieved (NRS = 3/10) 15, 60 and 120 minutes after starting treatment. •Morphine consumption (mg) 60 and 120 minutes after starting treatment. •Time (minutes) to obtain an effective analgesia •Time (minutes) to obtain a venous access;Primary end point(s): Proportion of subjects relieved (numeric rating scale = 3/10) 30 minutes after starting treatment in each group.;Timepoint(s) of evaluation of this end point: 30 minutes after starting treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Side events occurring during management up to 4 hours after treatment initiation • Proportion of patients relieved (NRS = 3/10) 15, 60 and 120 minutes after starting treatment. • Morphine consumption (mg) 60 and 120 minutes after starting treatment. • Time (minutes) to obtain an effective analgesia • Time (minutes) to obtain a venous access;Timepoint(s) of evaluation of this end point: • 4 hours after treatment initiation. • 15, 60 and 120 minutes after starting treatment. • 60 and 120 minutes after starting treatment. • from starting treatment to obtain an effective analgesia (minutes) • from starting treatment to obtain a venous access (minutes) | — |
Countries
France
Contacts
Public ContactCéline BAIRRAS-MARTIN
CHU de Bordeaux
Outcome results
None listed