Intranasal Sufentanil for Analgesia of Severe Sickle Cell Vaso-occlusive Pain Crisis in the Pediatric

NCT06181695 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: APHP211035
• Study Type: interventional
• Target: 182
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Vaso-occlusive Crisis

Outcome Measures

Primary Outcomes (1)

• Evaluation of the Efficacy of Intra-nasal Sufentanil for Analgesia of Vaso-occlusive Crisis in Sickle-cell in children

  efficacy of the analgesia at 30 minutes after IN injection, in children with SCD presenting to the pediatric ED with a severe VOC with Pain relief is defined as EVENDOL score ≤ 5/15 or NRS-11 score ≤ 3/10

  at 30 minutes

Secondary Outcomes (7)

• Proportion of children relieved (EVENDOL ≤ 5/15 or NRS-11 ≤ 3/10) at 10, 20, 40, 50 and 60 minutes after the IN injection inclusion

  at 60 minutes

• Proportion of children with a moderate pain (EVENDOL ≤ 9/15 or NRS-11 ≤ 6/10) at 10, 20, 30, 40, 50 and 60 minutes after the IN injection

  EVENDOL ≤ 5/15 or NRS-11 ≤ 3/10 at 10, 20, 40, 50 and 60 minutes

• To demonstrate that {IN Sufentanil +IV morphine(as a standard of care)} procedure, when compared to {IN Placebo + IV morphine (as a standard of care)} procedure, is able to decrease the level of morphine consumption

  from randomisation to 60 minutes after

• To demonstrate the safety of the {IN Sufentanil +IV morphine} procedure, when compared to {IN Placebo + IV morphine } procedure, that is an absence of increase rate of hemodynamic and non-hemodynamic side effects of opiace

  until 4 hours after the IN injection

• To evaluate the safety of all children aged 0-18 years

  From randomisaton to 4 hours after

Study Arms (2)

Sufentanil IN + Morphine IV

EXPERIMENTAL

Intranasal Sufentanil + IV morphine:

Drug: Sufentanil

Placebo IN + Morphine IV

PLACEBO COMPARATOR

Placebo of Sufentanil administered intranasally (IN) . One single administration +IV morphine similar to the experimental arm:

Drug: Sufentanil

Interventions

Sufentanil DRUG

Administration of intranasal sufentanil

Also known as: sufentanil IN + morphine IV

Placebo IN + Morphine IV; Sufentanil IN + Morphine IV

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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, blocked or traumatised nose

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Related Publications (29)

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MeSH Terms

Conditions

Vaso-Occlusive Crises

Interventions

Sufentanil

Condition Hierarchy (Ancestors)

Anemia, Sickle Cell; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Camille AUPIAIS, Pre

  Assistance Publique des Hopitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Camille AUPIAIS, Per

CONTACT

01 48 02 55 55; camille.aupiais@aphp.fr

Houda ALLALOU

CONTACT

01 48 95 74 07; houda.allalou@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: December 26, 2023
• Study Start: May 2, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 29, 2027
• Last Updated: December 26, 2023

Record last verified: 2023-12