Clonidine With Morphine in Patient Controlled Analgesia Pump in Vaso-Occlusive Crisis in Sickle Cell Disease Patient
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
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:
|
Outcome Measures
Primary Outcome Measures
- Morphine Consumption [Up to two weeks]
Morphine Consumption during hospitalisation
Secondary Outcome Measures
- 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)
Eligibility Criteria
Criteria
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
- B0762023230104