Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study of Intranasal Sufentanil and Intravenous Morphine for Severe Sickle Cell Pain Crisis in Children

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of severe pain crises in children with sickle cell disease. Sickle cell disease is a genetic condition that affects the red blood cells, causing them to become misshapen and leading to painful episodes known as vaso-occlusive crises. The study will explore the effectiveness of a medication called sufentanil, which is administered through the nose, followed by the standard treatment of morphine given through a vein. The goal is to determine if this combination provides better pain relief compared to a placebo followed by morphine.

Participants in the study will receive either the intranasal sufentanil or a placebo, and then morphine will be administered as soon as possible. The study will monitor the level of pain relief at various time points, starting from 30 minutes after the initial treatment. The trial aims to see if the combination of sufentanil and morphine can offer quicker and more effective pain relief for children experiencing these severe pain episodes.

The study will also observe any side effects that may occur, such as low blood pressure, breathing difficulties, or nausea, and will assess the overall satisfaction with the pain management provided. The trial is designed to improve the understanding of how to best manage severe pain in children with sickle cell disease, potentially leading to better treatment options in the future.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon arrival at the pediatric emergency department, an assessment of pain severity is conducted using the EVENDOL scale for children under 8 years or the Numeric Pain Rating Scale (NRS-11) for children aged 8 to less than 18 years.

    Severe pain is defined as an EVENDOL score of 10 or higher out of 15, or an NRS-11 score of 7 or higher out of 10.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either an intranasal (IN) spray of sufentanil or a placebo.

    This step is crucial to ensure the study's validity by comparing the effects of the active medication against a non-active substance.

  3. Step 3

    Administration of intranasal spray

    The assigned IN spray is administered to the participant.

    The goal is to evaluate the effectiveness of the IN spray in providing pain relief within 30 minutes.

  4. Step 4

    Intravenous morphine administration

    Following the IN spray, morphine hydrochloride is administered intravenously (IV) as soon as possible.

    This step is part of the standard care for managing severe pain in sickle cell disease.

  5. Step 5

    Pain evaluation

    Pain relief is assessed at multiple intervals: 10, 20, 30, 40, 50, and 60 minutes after the IN spray.

    Relief is defined as an EVENDOL score of 5 or lower out of 15, or an NRS-11 score of 3 or lower out of 10.

  6. Step 6

    Monitoring and follow-up

    Participants are monitored for any side effects such as low blood pressure, breathing difficulties, or nausea for up to 4 hours after the IN spray.

    Additional assessments include the amount of morphine used and the time taken to achieve pain relief.

  7. Step 7

    Discharge and satisfaction survey

    Decisions regarding hospital admission or discharge are made based on the participant's condition.

    A survey is conducted to assess satisfaction with pain management during the emergency room stay.

Who can join the trial?

9 criteria

  • The patient must have sickle cell disease, which is a blood disorder. This includes types like Hemoglobin SS, SC, or Sβ-thalassemia.
  • The patient must be younger than 18 years old.
  • The patient must weigh more than 10 kilograms (about 22 pounds).
  • The patient must be registered with the social security scheme or have State Medical Aid (AME), or be a beneficiary of these.
  • The person who has parental authority over the patient must give informed consent, which means they agree to the patient participating in the study after understanding what it involves.
  • At the time of randomization, the patient must be experiencing a vaso-occlusive crisis, which is a type of pain crisis common in sickle cell disease. This can include migratory bone pain in areas like the limbs, spine, chest, pelvis, or skull, or a crisis recognized by the patient.
  • The patient must have severe pain as determined during triage, which is the initial assessment in the emergency department. This is defined as:
    • An EVENDOL score of 10 or more out of 15 for children aged 0-18 years. This is a pain scale used for children over 8 years old during randomization.
    • An NRS-11 score of 7 or more out of 10 for children aged 8 to less than 18 years. This is another pain scale used to measure pain intensity.
    • The informed consent from the person with parental authority must be signed either at the inclusion visit or at the randomization visit.

Who cannot join the trial?

5 criteria

  • Patients who are not experiencing a vaso-occlusive crisis due to sickle cell disease. A vaso-occlusive crisis is a painful event that happens when blood flow is blocked due to sickle-shaped red blood cells.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to receive the medications used in the study, such as sufentanil or morphine. Sufentanil and morphine are medications used to relieve pain.
  • Patients who have any medical condition that the study doctors believe would make it unsafe for them to participate.
  • Patients who are part of a vulnerable population that the study is not designed to include.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Sufentanil

    This medication is used in the trial to provide pain relief. It is administered through the nose (intranasally) to help manage severe pain quickly. In this study, it is being tested to see if it can effectively reduce pain in children experiencing a sickle cell pain crisis.

  • Morphine

    This medication is a standard treatment for severe pain and is given through an IV (intravenously) in this trial. It is used to help manage pain in children with sickle cell disease who are experiencing a severe pain crisis. The trial is testing how well morphine works when used after intranasal sufentanil.

What is already known about the treatment

Sufentanil – Sufentanil is administered intranasally and is being studied for its effectiveness in treating severe pain crises in children with sickle cell disease. It is currently under investigation in clinical trials to assess its potential benefits in this specific condition. The main therapeutic indication is to provide pain relief during vaso-occlusive crises associated with sickle cell disease. Sufentanil works by binding to opioid receptors in the brain, which helps to reduce the perception of pain. It is classified as an opioid analgesic.

Investigated diseases

Sickle Cell Disease – Sickle cell disease is a genetic blood disorder characterized by the production of abnormal hemoglobin, leading to the distortion of red blood cells into a sickle shape. These sickle-shaped cells can block blood flow in small vessels, causing pain and potential organ damage. The disease often results in episodes known as vaso-occlusive crises, where the blocked blood flow leads to severe pain and swelling. Over time, repeated episodes can cause damage to organs and tissues. The condition is chronic and can affect various parts of the body, including the spleen, liver, and kidneys. It is most commonly found in individuals of African, Mediterranean, or Middle Eastern descent.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2023-504847-15-00Protocol codeAPHP211035Estimated enrolment915 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.