Advantage of Clonidine With Morphine In Patient Controlled Analgesia Pump for the Treatment of Vaso-occlusive Crisis in Sickle Cell Disease Patients
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Morphine Consumption
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Unmarked bags of products, randomised before administration.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Vaso-Occlusive Crisis In Sickle Cell disease Patients
排除标准
- •Patient's refusal
- •Pregnancy
- •Contr-indication Clonidine therapy
研究组 & 干预措施
Clonidine and Morphine
Morphine Associated with Clonidine PCIA
干预措施: Clonidine (Drug)
结局指标
主要结局
Morphine Consumption
时间窗: Up to two weeks
Morphine Consumption during hospitalisation
次要结局
- Numerical Rating Scale(Up to two weeks)
- Biology markers(Up to two weeks)
- Biopsychosocial model / ASCQ-ME questionary(Up to two weeks)
研究者
Lara Chow Yuen
Principal Investigator
Centre Hospitalier Universitaire Saint Pierre