Cohort Study of Sickle Cell Patients Evaluating Analgesic Strategies and Their Consequences
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 257
- 试验地点
- 3
- 主要终点
- Diagnosis of opioid use disorder
研究概览
简要总结
To date, there is no comprehensive data among adults with sickle cell disease concerning the prevalence of consumption of level 2 and 3 analgesics at home and the use of cannabis or CBD for analgesic use. Preliminary data shows a very high prevalence of an opioid use disorder (OUD) in these patients, above 50%, but more precise additional studies are necessary to objectify these results and implement appropriate multidisciplinary care.
The general objective of this project is to establish an exhaustive collection on the addiction of sickle cell patients followed in a sickle cell reference center (hôpital Henri Mondor, hôpital Necker-Enfants Malades and hôpital européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris). The study investigative team proposes to set up a prospective observational study using a questionnaire.
详细描述
Sickle cell disease is one of the most common genetic diseases in the world with approximately 300,000 births per year of children with sickle cell disease. It is linked to the presence of a mutation on the beta globin chain (beta S mutation), responsible for the expression of the S variant of hemoglobin (HbS). Inherited autosomal recessively, is characterized, among other things, by intense painful vaso-occlusive crises (VOC) of bone triggered by cold, dehydration, stress or fatigue, but also sometimes without an identified triggering factor. The management of VOC requires, among other things, the rapid administration of analgesics. Level 1 seems ineffective and patients most often resort to level 2 from the start of symptoms, then level 3 in a hospital setting if the latter are ineffective. Sickle cell patients also frequently present with chronic pain, sometimes linked to complications of the disease (chronic leg ulcers, osteonecrosis in particular) but also without an identified cause.
The prescription of level 2 is therefore quite widely used in these patients for both the management of acute and chronic pain. In addition, self-management of pain has been encouraged for several years by caregivers, with the risk of more or less controlled self-medication, but little data is available in the literature.
Consequently, repeated exposure to opioids, as well as the painful context, constitute risk factors for the development of an opioid use disorder (OUD).
To date, there is no comprehensive data among adults with sickle cell disease concerning the prevalence of consumption of level 2 and 3 analgesics at home and the use of cannabis or CBD for analgesic use. Preliminary data shows a very high prevalence of OUD in these patients, above 50%, but more precise additional studies are necessary to objectify these results and implement appropriate multidisciplinary care.
The general objective of this project is to establish an exhaustive collection on the addiction of sickle cell patients followed in a sickle cell reference center (hôpital Henri Mondor, hôpital Necker-Enfants Malades and hôpital européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris). The study investigative team proposes to set up a prospective observational study using a questionnaire.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Adult patient.
- •Sickle cell patient benefiting from a consultation or a session in a day hospital in one of the three reference centers (Necker Hospital, Mondor Hospital, Georges Pompidou European Hospital).
- •Patient informed of the study and not opposed to participating in the research.
排除标准
- •Patient under guardianship or curatorship.
- •Non-literate patient.
结局指标
主要结局
Diagnosis of opioid use disorder
时间窗: Time 0
The diagnosis of OUD will be established according to the criteria of the 5th version of the Diagnostic and Statistical Manual of Mental Illnesses (DSM 5). In this version the diagnosis of a use disorder is made if a patient meets 2 criteria among the 11 specified over a period of at least 12 months. These criteria cover four dimensions: loss of control over consumption (4 criteria), social impairment of functioning (3 criteria), continuation of use despite the risks incurred or presented (2 criteria), and physical symptoms (2 criteria). Depending on the number of criteria met, a gradation of severity is established: mild OUD (2 to 3 criteria), moderate (4 to 5 criteria), or severe (6 criteria or more).
次要结局
- Cannabis use(Time 0)
- Consumption of CBD for analgesic purposes(Time 0)
- Tobacco consumption(Time 0)
- Use of vaping(Time 0)
- Factors linked to sickle cell disease and associated with substance use: opioids, cannabis, CBD and tobacco(Time 0)