Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06650059
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-17
Brief Title:
Cohort Study of Sickle Cell Patients Evaluating Analgesic Strategies and Their Consequences
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Cohort Study of Sickle Cell Patients Evaluating Analgesic Strategies and Their Consequences
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DDAM
Brief Summary:
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
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
Detailed Description:
Sickle cell disease is one of the most common genetic diseases in the world with approximately 300000 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None