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

March 6, 2023 updated by: University Hospital, Bordeaux
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Pain of VOC in sickle-cell patients seen in the emergency department (ED) is severe. Analgesia is a therapeutic emergency based on intravenous (IV) morphine titration. However, for technical reasons (patient flow in ED, difficult venous access) this treatment is often delayed. The Equimolar Mixture of Oxygen-Nitrous Oxide (EMONO), an inhaled analgesic administered, makes it possible to temporarily and very partially compensate for the major analgesic defect. Its efficacy in this indication has never been demonstrated; it is less effective than opiates during labour and is associated with a risk of addiction. The intranasal (IN) route is used to administer strong opiates such as sufentanil. Sufentanil IN has been shown to be rapidly effective in traumatology. Its duration of action is similar to that of morphine IV but its duration of action is far too short to completely replace it. Its ideal place would therefore be the initial phase of the management while waiting for a venous approach.

The strategy is to propose an intranasal administration of an opioid (Sufentanil) at the initial management of vaso-occlusive crisis in sickle-cell patients in the ED waiting to a venous route for morphine.

Follow-up of the study will be carried out in the ED with numeric rating scale (NRS) measurement every 5 minutes until patient relief (defined by NRS ≤ 3/10). Once relieved, NRS will be measured every 15 minutes for at least 2 hours. Treatment-related side effects will be systematically investigated up to 4 hours after starting treatment. In particular, the respiratory rate and level of consciousness will be measured, and all side effects will be recorded: nausea, vomiting, dizziness, behavioural disorders, pruritus.

Study Type

Interventional

Enrollment (Anticipated)

196

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
    • all neurologic signs or consciousness impairment (coma Glasgow scale under 15)
    • hyperthermia over than 39°C
    • Signs of intolerance of acute anemia
    • Signs of hemodynamic failure
    • Known organ failure (renal insufficiency, pulmonary high blood pressure)
    • A description by the patient of a non usual crisis.
  • Current treatment with nasal vasoconstrictors is ongoing
  • Head injury with suspicion of high intracranial pressure
  • Severe thoracic trauma or decompensated respiratory insufficiency

  • Contraindications of intranasal administration:

    • Facial trauma
    • Nose or sinusal surgery in the previous 6 months before inclusion
    • Chronic nose and upper airway alteration (ex. facial malformation)
    • Acute nose and upper airway alteration (ex. Epistaxis, acute respiratory infection, sinusitis).
  • Contraindication to nitrous oxide
  • Contraindication to morphine
  • Patient's refusal to participate in the study.
  • Previous inclusion in the study of less than 14 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
The intervention is intranasal Sufentanil adminstration, then IV morphine as soon as possible.
Active Comparator: Control

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients relieved (NRS ≤ 3/10) 30 minutes after starting treatment in each group.
Time Frame: From date of inclusion to 30 minutes after
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events occuring until 4 hours after treatment initiation.
Time Frame: From date of inclusion to 4 hours after
This outcome is defined by the proportion of patients with at least one adverse events during the medical care, until 4 hours after treatment initiation.
From date of inclusion to 4 hours after
Morphine consumption (mg)
Time Frame: from date of inclusion to 60 minutes after
Assessed morphine consumption after treatment initiation, until 60 minutes.
from date of inclusion to 60 minutes after
Morphine consumption (mg)
Time Frame: from date of inclusion to 120 minutes after
Assessed morphine consumption after treatment initiation, until 120 minutes.
from date of inclusion to 120 minutes after
Time to obtain an effective analgesia
Time Frame: through study completion, an average of 4 hours
Defined an average time to obtain an effective analgesia, after treatment initiation
through study completion, an average of 4 hours
Time to obtain a venous access
Time Frame: through study completion, an average of 4 hours
Defined an average time to obtain a venous access, after treatment initiation
through study completion, an average of 4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Study Chair: Eric FRISON, Dr, USMR

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2021

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

August 30, 2019

First Submitted That Met QC Criteria

August 30, 2019

First Posted (Actual)

September 3, 2019

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

March 6, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2017/46

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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