Status:
NOT_YET_RECRUITING
Intranasal Sufentanil for Analgesia of Severe Sickle Cell Vaso-occlusive Pain Crisis in the Pediatric
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Vaso-occlusive Crisis
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE3
Brief 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 ma...
Detailed Description
Sufentanil is a powerful opioid analgesic used intravenously by emergency physicians for the sedation of intensive care, intubated and ventilated patients. It is therefore already present in the pharm...
Eligibility Criteria
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
- 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
- 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
Key Trial Info
Start Date :
May 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 29 2027
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT06181695
Start Date
May 2 2024
End Date
May 29 2027
Last Update
December 26 2023
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