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

Phase 4

Recruiting

• Conditions: Vaso-occlusive Pain Episode in Sickle Cell Disease; Sickle Cell Disease
• Interventions: Drug: Clonidine

• Registration Number: NCT05848531
• Lead Sponsor: Centre Hospitalier Universitaire Saint Pierre

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-30
• Status Verified: 2023-04
• Study Start: 2023-04-25
• Study First Submitted QC: 2023-05-05
• Last Update Submitted: 2023-05-05
• Study First Posted: 2023-05-08
• Last Update Posted: 2023-05-08
• Primary Completion: 2023-12-31
• Study Completion: 2024-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Vaso-Occlusive Crisis In Sickle Cell disease Patients

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clonidine and Morphine	Clonidine	Morphine Associated with Clonidine PCIA

Primary Outcome Measures

Name	Time	Method
Morphine Consumption	Up to two weeks	Morphine Consumption during hospitalisation

Secondary Outcome Measures

Name	Time	Method
Numerical Rating Scale	Up to two weeks	Pain Score scale from 0 to ten during and after treatment
Biology markers	Up to two weeks	Inflammatory biology markers (CRP,IL-6) and Hemolysis (LDH)
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)

Trial Locations

Locations (1)

CHU Saint-Pierre; 🇧🇪 Bruxelles, Belgium