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

Centre Hospitalier Universitaire Saint Pierre

Status and phase: Enrolling; Phase 4

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

Treatments: Drug: Clonidine

Study type: Interventional

Funder types: Other

Identifiers

NCT05848531

B0762023230104

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Vaso-Occlusive Crisis In Sickle Cell disease Patients

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Morphine

No Intervention group

Description:

Standard Morphine PCIA

Clonidine and Morphine

Experimental group

Description:

Morphine Associated with Clonidine PCIA

Treatment:

Drug: Clonidine