Frontlight ResearchEarly access
Taking people in FrancePhase 3
Nasal Sufentanil for Pain in Children with Sickle Cell Pain Crisis
Tests nasal sufentanil with morphine for severe pain in children with sickle cell disease.
Key facts
- Who runs it
- Assistance Publique Hopitaux De Paris
- Where
- Aulnays-Sous-Bois, Bondy, Boulogne-Billancourt, Cayenne, Clamart, Colombes, Corbeil-Essonnes, Créteil, Le Coudray, Le Kremlin-Bicetre, Lille Cedex, Nantes, and Saint-Denis, FranceSee the 13 sites
- Trial code
- Registry title
- Intranasal Sufentanil for Analgesia of Severe Sickle Cell Vaso-occlusive Pain Crisis in the Pediatric Emergency Department
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 915 people, planned
- Started
- 21 Jul 2025
- Expected to end
- 21 Jan 2029
- Type of study
- Interventional
- Record updated
- 22 December 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and teenagers with sickle cell disease who come to the pediatric emergency department with severe pain from a vaso-occlusive crisis. It tests nasal sufentanil against placebo, each followed by IV morphine.
- Age
- Under 18 years old, and weighing more than 10 kg (22 lb).
- Sex
- Boys and girls can both join.
- Disease stage
- Sickle cell disease (hemoglobin SS, SC or Sß-thalassemia) with a vaso-occlusive pain crisis. Pain must be severe at triage: EVENDOL 10/15 or more, or NRS-11 7/10 or more (NRS-11 for children aged 8 to under 18).
- Earlier treatment
- Cannot have had a strong opioid (such as morphine, oxycodone, hydromorphone, fentanyl, sufentanil, nalbuphine) in the last 6 hours.
Main reasons for not taking part
- Known cirrhosis or end-stage kidney disease needing dialysis
- Known allergy to sufentanil, its excipients or morphine
- Facial malformation, nosebleed, or a blocked or injured nose
- Breathing problems, oxygen saturation below 95%, fast heart rate, low blood pressure, or altered consciousness
- Already in the INVOPE trial, in another interventional trial, or a positive pregnancy test in a girl able to have children
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in France
- Ctre Hospitalier Intercomm R BallangerAulnays-Sous-Bois, FranceTaking people
- Assistance Publique Hopitaux De ParisBondy, FranceTaking people
- Assistance Publique Hopitaux De ParisBoulogne-Billancourt, FranceTaking people
- Centre Hospitalier De CayenneCayenne, FranceTaking people
- Hopital Antoine BeclereClamart, FranceTaking people
- Assistance Publique Hopitaux De ParisColombes, FranceTaking people
- Centre Hospitalier Sud FrancilienCorbeil-Essonnes, FranceTaking people
- Centre Hospitalier Intercommunal CréteilCréteil, FranceTaking people
- Les Hopitaux De ChartresLe Coudray, FranceTaking people
- Assistance Publique Hopitaux De ParisLe Kremlin-Bicetre, FranceTaking people
- Centre Hospitalier Universitaire De LilleLille Cedex, FranceTaking people
- Centre Hospitalier Universitaire de NantesNantes, FranceTaking people
- Centre Hospitalier de Saint-DenisSaint-Denis, FranceTaking people
About the trial
What the trial wants to find out
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- 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)
- Plain-language title
- Nasal Sufentanil for Pain in Children with Sickle Cell Pain CrisisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 22 December 2025