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

NCT04076748 | Unknown Phase 3 DMC

• 1 other identifier: CHUBX 2017/46
• Study Type: interventional
• Target: 196
• Locations: 2 countries
• Sites: 7

Brief Summary

The analgesic treatment for vaso-occlusive crisis (VOC) in sickle-cell patients is an emergency. The reference treatment is morphine, which requires a venous way sometimes difficult to obtain in these patients. Sufentanil intranasal has been shown to be effective in traumatology. The objective is to evaluate, in VOC, the efficacy of intranasal sufentanil relayed by morphine IV compared to the usual protocol, Equimolar Mixture of Oxygen-Nitrous Oxide (EMONO) relayed by morphine intravenous (IV).

Conditions

Sickle Cell Crisis

Keywords

analgesia; vaso-occlusive crisis; sufentanil; intra-nasal

Outcome Measures

Primary Outcomes (1)

• Proportion of patients relieved (NRS ≤ 3/10) 30 minutes after starting treatment in each group.

  This proportion is measured thanks to a numeric rating scale (NRS). The scale define pain intensity, range between 0 and 10, 10 being the worst pain imaginable and 0 the absence of pain. The NRS is measured every 5 minutes until patient relief (defined by NRS ≤ 3/10).

  From date of inclusion to 30 minutes after

Secondary Outcomes (5)

• Adverse events occuring until 4 hours after treatment initiation.

  From date of inclusion to 4 hours after

• Morphine consumption (mg)

  from date of inclusion to 60 minutes after

• Morphine consumption (mg)

  from date of inclusion to 120 minutes after

• Time to obtain an effective analgesia

  through study completion, an average of 4 hours

• Time to obtain a venous access

  through study completion, an average of 4 hours

Study Arms (2)

Experimental

EXPERIMENTAL

\* Intra Nasal Sufentanil (50 µg.ml-1): Load dose : 0.3 µg. kg-1, Followed by bolus : 5 µg / 10 minutes with 2 bolus maximum. As soon as the venous route and ten minutes after the last administration of sufentanil: * Morphine IV: 3 mg / 5 minutes. * Objective: numeric rating scale (NRS) ≤ 3/10.

Drug: Sufentanil

Control

ACTIVE COMPARATOR

\* EMONO : Given by respiratory administration via a face mask at a rate suitable for patient ventilation (generally at least 9l.min-1), Until a venous route is obtained and without exceeding 30 minutes. \* Morphine IV: Load dose: 0.1mg. kg-1 as soon as possible; Then bolus: 3mg / 5 minutes. \* Objective: NRS ≤ 3/10

Drug: EMONO

Interventions

Sufentanil DRUG

The intervention is intranasal Sufentanil adminstration, then IV morphine as soon as possible.

Experimental

EMONO DRUG

In the control group, patients will receive EMONO then IV morphine as soon as possible.

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 75 years old;
• Sickle-cell patient.
• Signs of a 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 (NRS ≥ 6/10) on admission to the ED;
• Registered with the social security scheme or his beneficiaries (except AME)
• Signature of free and informed consen.

You may not qualify if:

• Strong opioids received in the previous 6 hours;
• Pregnancy or breastfeeding;
• Woman not menopausal nor sterile without effective contraception (HAS criteria)
• Oxygen saturation below 93%;
• Patients who cannot cooperate because of a State of agitation or a Cognitive impairment
• Unable to communicate;
• Unable to do self-assessment;
• Allergy or intolerance to opiates or nitrous oxide.
• Abuse or addiction to opioids
• Liver insufficiency
• Renal insufficiency
• Severe asthma or chronic obstructive bronchopulmonary disease
• Pulmonary disease necessitating oxygen
• Presence of seriousness signs:
• All respiratory seriousness signs

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (8)

Hopital Pellegrin

Bordeaux, 33000, France

RECRUITING

Hôpital Louis Mourier

Colombes, 92700, France

NOT YET RECRUITING

Gonesse Hospital

Gonesse, 95500, France

RECRUITING

Hôpital Edouard Herriot

Lyon, 69003, France

RECRUITING

Hôpital Charles Nicolle

Rouen, 76031, France

NOT YET RECRUITING

Hôpital Rangueil

Toulouse, 31059, France

RECRUITING

CH de Cayenne

Cayenne, 97306, French Guiana

RECRUITING

CHU Pointe à Pitre

Les Abymes, 97159, Guadeloupe

NOT YET RECRUITING

MeSH Terms

Conditions

Vaso-Occlusive Crises; Agnosia

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; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Eric FRISON, Dr

  USMR

  STUDY CHAIR

Central Study Contacts

Michel GALINSKI, Pr

CONTACT

5 56 79 48 26; michel.galinski@chu-bordeaux.fr

Cedric GIL-JARDINE, Dr

CONTACT

cedric.gil-jardine@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2019
• First Posted: September 3, 2019
• Study Start: July 20, 2021
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: March 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6); GU (1)