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

• Status: Not yet recruiting
• Trial end date: 2027-05-29
• Target enrollment: 0
• Participant gender: All

Summary

Sickle cell disease (SCD) is characterized by an abnormal hemoglobin, the main protein in the red blood cell. From the first months of life, acute obstruction of the vessels of the microcirculation manifests as intense and unpredictable recurrent episodes of severe pain. In the Emergency Department (ED), patients presenting with a vaso-occlusive crisis (VOC) required a rapid evaluation and administration of pain relief therapies and hydration.

this strategy is based on an intranasal (IN) administration of Sufentanil at the initial management of children with VOC, followed by morphine intravenous (IV) relay as soon as possible, compared to the usual care procedure with IV morphine as soon as possible.

The hypothesis is that the use of this IN opioid at the beginning of the management of children with VOC can reduce the time before being pain relieved. Indeed, the IN administration make it easier and faster to administer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Dsuvia; Morphine; Sufentanil

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