Intranasal Sufentanil for Analgesia of Severe Sickle Cell Vaso-occlusive Pain Crisis in the Pediatric Emergency Department

Phase 1

Conditions: vaso-occlusive crisis due to sickle cell disease
MedDRA version: 20.0Level: LLTClassification code: 10072397Term: Vaso-occlusive crisis Class: 10005329
Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]

Registration Number: CTIS2023-504847-15-00

Lead Sponsor: Assistance Publique Hopitaux De Paris

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 915

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, At randomization visit •Age < 18 years old •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 0-18 years (this pain scale is allowed in children > 8 years only for randomization) 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 or at randomisation visit

Exclusion Criteria

At inclusion visit •Known cirrhosis •End-stage renal disease requiring kidney dialysis •Known hypersensitivity to sufentanil, any of the excipients or to morphine •Facial malformation, epistaxis, blocked or traumatised nose. •Patient's or parent's refusal to participate •Parents who do not speak French, At randomization visit •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 •Hemodynamic disorders: tachycardia, hypotension •Altered conscious state as defined by a Glasgow Coma score less than 15 •Patient's or Parent's refusal to participate or withdrawal of parental consent •Patient has already been randomised to the INVOPE trial during a previous VOC •Positive urinary pregnancy test for woman of childbearing potential (postpubertal female with sexual activity), •Participation in another interventional trial