Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2025-12-24 @ 1:38 PM
NCT ID:
NCT06181695
Eligibility Criteria:
Inclusion Criteria:
At inclusion visit:
* Sickle-cell disease = Hemoglobin SS or SC or Sß-thalassemia
* Age \< 18 years old
* Weight \> 10 kgs
* Registered with the social security scheme (or State Medical Aid - AME) or his/her beneficiaries
* Informed consent of the holder (s) of the exercise of parental authority
* Age \< 18 years old
At randomisation visit
* Presenting to the ED with 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 determined at triage, defined as:
* EVENDOL ≥ 10/15 in children aged 0-8 years or
* NRS-11 ≥ 7/10 in children aged 8 years to less than 18 years
* Informed consent of the holder (s) of the exercise of parental authority signed at inclusion visit
Exclusion Criteria:
* At inclusion visit
* Known cirrhosis
* End-stage renal disease requiring kidney dialysis
* Known hypersensitivity or contraindication to sufentanil or any of the excipients
* Contraindication to morphine
* Facial malformation, epistaxis, blocked or traumatised nose
* Severe asthma
* Patient's or parent's refusal to participate
* Participation in another interventional trial
* Parents who do not speak French
At randomization visit
* Known cirrhosis
* End-stage renal disease requiring kidney dialysis
* Known hypersensitivity or contraindication to sufentanil or any of the excipients
* Contraindication to morphine
* Facial malformation, epistaxis, blocked or traumatised nose
* Severe asthma
* Patient's or Parent's refusal to participate or withdrawal of parental consent
* Participation in another interventional trial
* Patient has already been randomised to the INVOPE trial during a previous VOC
* Strong opioids received \<6 hours (morphine, oxycodone, hydromorphone, fentanyl, sufentanil, nalbuphine)
* Respiratory failure (tachypnea; bradypnea; paradoxical breathing; grunting; head-bobbing; nasal flaring; retractions (subcostal, suprasternal, intercostal, sternal))
* Oxygen saturations below 95% on initial assessment
* Pneumonia requiring oxygen therapy
* Hemodynamic disorders: tachycardia, hypotension
* Altered conscious state as defined by a Glasgow Coma score less than 15
* Positive urinary pregnancy test for woman of childbearing potential (postpubertal female with sexual activity)
* Nasal or sinus surgery within 6 months before randomisation
* High fever \> 39°C
* Sign of intolerance of acute anaemia
* Description by the patient (or the parents) of the unusual nature of the attack
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT06181695
Study Brief:
Protocol Section:
NCT06181695