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

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What is this study about?

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.

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 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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Intercommunal Creteil	Creteil	France

Other Sites

Site Name	City	Country
Hopital Antoine Beclere	Clamart	France
Centre Hospitalier Sud Francilien	Corbeil Essonnes	France
Assistance Publique Hopitaux De Paris	Bondy	France
Hopital Ambroise Pare	Boulogne-Billancourt	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier De Cayenne	Cayenne	France
Les Hopitaux De Chartres	Le Coudray	France
Ctre Hospitalier Intercomm R Ballanger	Aulnays-Sous-Bois	France
Assistance Publique Hopitaux De Paris	Creteil	France
Centre Hospitalier De Saint-Denis	St Denis	France
Hopital Jeanne De Flandre	Lille	France
Arerlxldsw Phxhkpsv Hzojvboi Dy Plxix	Le Kremlin-Bicetre	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	21.07.2025

Trial locations

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.

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 ID:

2023-504847-15-00

Protocol code:

APHP211035

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?