Intranasal Sufentanil for Analgesia of Severe Sickle Cell Vaso-occlusive Pain Crisis in the Pedia… (NCT06181695) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Intranasal Sufentanil for Analgesia of Severe Sickle Cell Vaso-occlusive Pain Crisis in the Pediatric
182 participantsStarted 2024-05-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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,…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluation of the Efficacy of Intra-nasal Sufentanil for Analgesia of Vaso-occlusive Crisis in Sickle-cell in children