2023-504847-15-00RecruitingPhase 3
Intranasal Sufentanil for Analgesia of Severe Sickle Cell Vaso-occlusive Pain Crisis in the Pediatric Emergency Department
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)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 22 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 915 (estimated)
- First submitted
- 29 Aug 2023
- Start date
- 21 Jul 2025
- Lead sponsor
- Assistance Publique Hopitaux De Paris
- Diseases
- Sickle cell disease
- EU CT number
- 2023-504847-15-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 915
- 13 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
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.
- 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
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
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
- 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
Age in the registry: - to 17 years · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ctre Hospitalier Intercomm R Ballanger | Aulnays-Sous-Bois | France | Recruiting |
| Assistance Publique Hopitaux De Paris | Bondy | France | Recruiting |
| Assistance Publique Hopitaux De Paris | Boulogne-Billancourt | France | Recruiting |
| Centre Hospitalier De Cayenne | Cayenne | France | Recruiting |
| Hopital Antoine Beclere | Clamart | France | Recruiting |
| Assistance Publique Hopitaux De Paris | Colombes | France | Recruiting |
| Centre Hospitalier Sud Francilien | Corbeil-Essonnes | France | Recruiting |
| Centre Hospitalier Intercommunal Créteil | Créteil | France | Recruiting |
| Les Hopitaux De Chartres | Le Coudray | France | Recruiting |
| Assistance Publique Hopitaux De Paris | Le Kremlin-Bicetre | France | Recruiting |
| Centre Hospitalier Universitaire De Lille | Lille Cedex | France | Recruiting |
| Centre Hospitalier Universitaire de Nantes | Nantes | France | Recruiting |
| Centre Hospitalier de Saint-Denis | Saint-Denis | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.