PHEDRE trial protocol – observational study of the prevalence of problematic use of Equimolar Mixture of Oxygen and Nitrous Oxide (EMONO) and analgesics in the French sickle-cell disease population
| Autor: | Caroline Victorri-Vigneau, Pascale Jolliet, Marie Grall-Bronnec, Marie Gérardin, Morgane Rousselet, Marie-Lyne Pinot, Fanny Feuillet, Fanny Perrouin, Marie-Laure Couec, Olivier Bonnot, Laura Wainstein, Marie-Hélène Drouineau |
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| Přispěvatelé: | Centre hospitalier universitaire de Nantes (CHU Nantes), Biostatistique, Recherche Clinique et Mesures Subjectives en Santé, Université de Nantes (UN), Service de Pharmacologie Clinique [CHU Nantes], Centre for Evaluation and Information on Pharmacodependence [Nantes], Clinical Pharmacology Department [Nantes], Centre hospitalier universitaire de Nantes (CHU Nantes)-Centre hospitalier universitaire de Nantes (CHU Nantes), Audition (Psychophysique, Modélisation, Neurosciences) (APMN), Laboratoire des systèmes perceptifs (LSP), Département d'Etudes Cognitives - ENS Paris (DEC), École normale supérieure - Paris (ENS Paris), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-École normale supérieure - Paris (ENS Paris), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Centre National de la Recherche Scientifique (CNRS)-Département d'Etudes Cognitives - ENS Paris (DEC), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Centre National de la Recherche Scientifique (CNRS) |
| Rok vydání: | 2015 |
| Předmět: |
Male
[SDV]Life Sciences [q-bio] Nitrous Oxide Sickle-cell disease Problematic use Disease Study Protocol Equimolar Mixture of Oxygen and Nitrous Oxide (EMONO) Pseudo-addiction Sickle Cell/*drug therapy Medicine Child Pain Measurement media_common Analgesics education.field_of_study Medical record Anemia ArtThese Sickle Cell 3. Good health Substance abuse Psychiatry and Mental health Female Analgesic drugs France Adult medicine.medical_specialty Adolescent Substance-Related Disorders media_common.quotation_subject Population Pain/*drug therapy Pain Context (language use) Anemia Sickle Cell Young Adult Humans Analgesics/*administration & dosage Intensive care medicine education Psychiatry Nitrous Oxide/*administration & dosage Substance use disorders business.industry Addiction medicine.disease Oxygen Telephone interview Oxygen/*administration & dosage Observational study business Substance-Related Disorders/complications |
| Zdroj: | BMC Psychiatry BMC Psychiatry, BioMed Central, 2015, 15, pp.281. ⟨10.1186/s12888-015-0677-5⟩ |
| ISSN: | 1471-244X |
| Popis: | International audience; BACKGROUND: The use of analgesics can lead to cases of drug abuse and dependence. It can also cause pseudo-addiction in patients suffering from pain. What is the actual situation in patients suffering from severe sickle-cell disease, exposed to acute pain during vaso-occlusive crises? Evaluation of the use of analgesics, on the basis of Diagnostic and Statistical Manual of Mental Disorders criteria for substance abuse and dependence, makes it possible to differentiate the symptoms occurring only in a context of pain, in the aim of managing the pain, and thus describing pseudo-addiction, from symptoms also occurring when there is no pain, and more in favour of true addiction. Currently there is no data available in France on this problem, and no studies have been carried out in children or adolescents with sickle-cell disease. The purpose of the study is to evaluate the prevalence of problematic use of equimolar mixture of oxygen and nitrous oxide and other analgesic drugs in a population of subjects with severe sickle-cell disease in France. METHODS/DESIGN: PHEDRE (Pharmacodépendance Et DREpanocytose-drug dependence and sickle-cell disease) is an observational, descriptive and transversal study. Patients under the age of 26 with sickle-cell disease are included in the study by the doctors looking after them in sickle-cell disease centres. The patients are then contacted by a trained researcher for a telephone interview, including an evaluation of the Diagnostic and Statistical Manual of Mental Disorders criteria for abuse and dependence to equimolar mixture of oxygen and nitrous oxide and for each of the analgesic drugs taken by the patient. The data are also completed using the subject's medical record. DISCUSSION: This study will make it possible to provide an initial quantitative and qualitative evaluation of problematic use of equimolar mixture of oxygen and nitrous oxide and analgesic drugs in the sickle-cell disease population. The results will be used firstly to provide additional data essential for monitoring the risk of overdose, abuse, dependence and misuse of these products, and to begin awareness-raising and to provide information for health care professionals, in order to significantly improve the management of sickle-cell disease-related pain. TRIAL REGISTRATION: Clinical Trials.gov ID: NCT02580565 registered 16 October 2015 Unique Protocol ID: RC14\₀344. |
| Databáze: | OpenAIRE |
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