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Clonidine With Morphine in Patient Controlled Analgesia Pump in Vaso-Occlusive Crisis in Sickle Cell Disease Patient

Sponsor
Centre Hospitalier Universitaire Saint Pierre (Other)
Overall Status
Recruiting
CT.gov ID
NCT05848531
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
10.2
Anticipated Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Vaso-occlusive crisis are highly painful in Sickle-cell patients. Morphine is the treatment of choice for this pain. Various adjuncts have been studied for the treatment of vaso-occlusive crisis.

The investigators aimed to study the effect of clonidine associated with morphine in PCIA (patient controlled intravenous analgesia pumps) regimen. The investigators will compare it to the morphine alone in PCIA for the treatment of vaso-occlusive pain.

The investigators will measure the morphine consumption of all patient, the impact on the apparition of the morphine secondary effect and on inflammation biomarkers and the biopsychosocial respond.

Each patient will be hospitalized and follow by haematologist from the hospital, pain doctors and nurses.

It will be a double blind randomised, prospective study. The randomisation will be done by the pharmacy.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Double Blinded, randomised, prospectiveDouble Blinded, randomised, prospective
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
Unmarked bags of products, randomised before administration.
Primary Purpose:
Treatment
Official Title:
Advantage of Clonidine With Morphine In Patient Controlled Analgesia Pump for the Treatment of Vaso-occlusive Crisis in Sickle Cell Disease Patients
Actual Study Start Date :
Apr 25, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Feb 28, 2024

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Morphine

Standard Morphine PCIA
Experimental: Clonidine and Morphine

Morphine Associated with Clonidine PCIA

Drug: Clonidine
Comparing Clonidine with Morphine PCIA for the treatment of Vaso-Occlusive crisis in Sickle Cell disease patient
Other Names:
  • Catapressan

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Morphine Consumption [Up to two weeks]

      Morphine Consumption during hospitalisation

    Secondary Outcome Measures

    1. Numerical Rating Scale [Up to two weeks]

      Pain Score scale from 0 to ten during and after treatment

    2. Biology markers [Up to two weeks]

      Inflammatory biology markers (CRP,IL-6) and Hemolysis (LDH)

    3. Biopsychosocial model / ASCQ-ME questionary [Up to two weeks]

      Evaluation of the biopsychosocial model. There are seven different themes of 4 to 7 questions each (pain intensity, pain episodes, sleep impact, social impact, emotional impact, medical history and stiffness)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Vaso-Occlusive Crisis In Sickle Cell disease Patients
    Exclusion Criteria:

    • Minor

    • Patient's refusal

    • Pregnancy

    • Contr-indication Clonidine therapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Saint-Pierre Bruxelles Belgium 1000

    Sponsors and Collaborators

    • Centre Hospitalier Universitaire Saint Pierre

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Lara Chow Yuen, Principal Investigator, Centre Hospitalier Universitaire Saint Pierre
    ClinicalTrials.gov Identifier:
    NCT05848531
    Other Study ID Numbers:
    • B0762023230104
    First Posted:
    May 8, 2023
    Last Update Posted:
    May 8, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Lara Chow Yuen, Principal Investigator, Centre Hospitalier Universitaire Saint Pierre
    Clonidine
    Morphine
    Acute Pain management
    patient controlled analgesia
    Additional relevant MeSH terms:
    Anemia, Sickle Cell
    Clonidine

    Study Results

    No Results Posted as of May 8, 2023