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

Study Overview
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Brief Summary
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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.

Official Title
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Advantage of Clonidine With Morphine In Patient Controlled Analgesia Pump for the Treatment of Vaso-occlusive Crisis in Sickle Cell Disease Patients

Conditions
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Sickle Cell Disease, Vaso-occlusive Pain Episode in Sickle Cell Disease

Intervention / Treatment
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* Drug: Clonidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Vaso-Occlusive Crisis In Sickle Cell disease Patients Exclusion Criteria: Minor Patient's refusal Pregnancy Contr-indication Clonidine therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double Blinded, randomised, prospective
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Morphine<br>Standard Morphine PCIA | |
| Experimental: Clonidine and Morphine<br>Morphine Associated with Clonidine PCIA | Drug: Clonidine<br>* Comparing Clonidine with Morphine PCIA for the treatment of Vaso-Occlusive crisis in Sickle Cell disease patient<br>* Other names: Catapressan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine Consumption | Morphine Consumption during hospitalisation | Up to two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Rating Scale | Pain Score scale from 0 to ten during and after treatment | Up to two weeks | 
| Biology markers | Inflammatory biology markers (CRP,IL-6) and Hemolysis (LDH) | Up to two weeks | 
| Biopsychosocial model / ASCQ-ME questionary | 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) | Up to two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clonidine, Morphine, Acute Pain management, patient controlled analgesia