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

Trial details

Who runs it

Assistance Publique Hopitaux De Paris

Trial code

EU 2023-504847-15-00

Record updated

2025. december 22.

Original description

To demonstrate the superiority of a procedure consisting in IN administration of sufentanil followed by IV administration of morphine as soon as possible {IN sufentanil + IV morphine (as a standard of care) }, when compared to placebo and IV administration of morphine as soon as possible {IN Placebo + IV morphine (as a standard of care)}, on the efficacy of the analgesia at 30 minutes, in children with SCD presenting to the pediatric ED with a severe VOC.Read full original descriptionShow less

Intranasal Sufentanil for Analgesia of Severe Sickle Cell Vaso-occlusive Pain Crisis in the Pediatric Emergency Department: a Double Blind Randomized versus placebo Controlled Trial (INVOPE)

To demonstrate the superiority of a procedure consisting in IN administration of sufentanil followed by IV administration of morphine as soon as possible {IN sufentanil + IV morphine (as a standard of care) }, when compared to placebo and IV administration of morphine as soon as possible {IN Placebo + IV morphine (as a standard of care)}, on the efficacy of the analgesia at 30 minutes, in children with SCD presenting to the pediatric ED with a severe VOC.

Inclusion: 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: 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; 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.

EU CTIS 2023-504847-15-00