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

NCT05848531 | Unknown Phase 4

• 1 other identifier: B0762023230104
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease; Vaso-occlusive Pain Episode in Sickle Cell Disease

Keywords

Clonidine; Morphine; Acute Pain management; patient controlled analgesia

Outcome Measures

Primary Outcomes (1)

• Morphine Consumption

  Morphine Consumption during hospitalisation

  Up to two weeks

Secondary Outcomes (3)

• Numerical Rating Scale

  Up to two weeks

• Biology markers

  Up to two weeks

• Biopsychosocial model / ASCQ-ME questionary

  Up to two weeks

Study Arms (2)

Morphine

NO INTERVENTION

Standard Morphine PCIA

Clonidine and Morphine

EXPERIMENTAL

Morphine Associated with Clonidine PCIA

Drug: Clonidine

Interventions

Clonidine DRUG

Comparing Clonidine with Morphine PCIA for the treatment of Vaso-Occlusive crisis in Sickle Cell disease patient

Also known as: Catapressan

Clonidine and Morphine

Eligibility Criteria

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

You may qualify if:

• Vaso-Occlusive Crisis In Sickle Cell disease Patients

You may not qualify if:

• Minor
• Patient's refusal
• Pregnancy
• Contr-indication Clonidine therapy

Sponsors & Collaborators

• Centre Hospitalier Universitaire Saint Pierre: lead

Study Sites (1)

CHU Saint-Pierre

Brussels, 1000, Belgium

RECRUITING

Related Publications (1)

• Kenney MO, Smith WR. Moving Toward a Multimodal Analgesic Regimen for Acute Sickle Cell Pain with Non-Opioid Analgesic Adjuncts: A Narrative Review. J Pain Res. 2022 Mar 31;15:879-894. doi: 10.2147/JPR.S343069. eCollection 2022.

  PMID: 35386424 BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Clonidine

Condition Hierarchy (Ancestors)

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)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Unmarked bags of products, randomised before administration.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Double Blinded, randomised, prospective

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: May 8, 2023
• Study Start: April 25, 2023
• Primary Completion: December 31, 2023
• Study Completion: February 28, 2024
• Last Updated: May 8, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)