Sickle Cell Disease, Vaso-occlusive Pain Episode in Sickle Cell Disease
Conditions
Keywords
Clonidine, Morphine, Acute Pain management, patient controlled analgesia
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.
Interventions
DRUGClonidine
Comparing Clonidine with Morphine PCIA for the treatment of Vaso-Occlusive crisis in Sickle Cell disease patient
Sponsors
Centre Hospitalier Universitaire Saint Pierre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Unmarked bags of products, randomised before administration.
Intervention model description
Double Blinded, randomised, prospective
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Vaso-Occlusive Crisis In Sickle Cell disease Patients
Exclusion criteria
* Minor * Patient's refusal * Pregnancy * Contr-indication Clonidine therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphine Consumption | Up to two weeks | Morphine Consumption during hospitalisation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Belgium
Outcome results
None listed