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NCT06181695Not yet recruitingPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 26 Dec 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
182 (estimated)
First submitted
15 Nov 2023
Start date
2 May 2024
Primary completion date
30 May 2026
Lead sponsor
Assistance Publique - Hôpitaux de Paris
NCT number
NCT06181695

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 182
  • From 2 May 2024 to the primary completion date, 30 May 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patient has already been randomised to the INVOPE trial during a previous VOC
  • Strong opioids received \<6 hours (morphine, oxycodone, hydromorphone, fentanyl, sufentanil, nalbuphine)
  • Pneumonia requiring oxygen therapy
  • Nasal or sinus surgery within 6 months before randomisation

Other illness

  • 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
  • End-stage renal disease requiring kidney dialysis
  • Known hypersensitivity or contraindication to sufentanil or any of the excipients
  • Respiratory failure (tachypnea; bradypnea; paradoxical breathing; grunting; head-bobbing; nasal flaring; retractions (subcostal, suprasternal, intercostal, sternal))
  • Hemodynamic disorders: tachycardia, hypotension

Other

  • Known cirrhosis
  • 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
  • Oxygen saturations below 95% on initial assessment
  • 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)
  • High fever \> 39°C
  • Sign of intolerance of acute anaemia
  • Description by the patient (or the parents) of the unusual nature of the attack

Who the study is looking for

  • 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

Age in the registry: - to 18 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.