Abstract

BackgroundThe 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/designPHEDRE (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.DiscussionThis 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 registrationClinical Trials.gov ID: NCT02580565 registered 16 October 2015Unique Protocol ID: RC14_0344

Highlights

  • The use of analgesics can lead to cases of drug abuse and dependence

  • 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

  • Cases of severe abuse and dependence to Equimolar Mixture of Oxygen and Nitrous Oxide (EMONO) have been declared to the French addiction monitoring system via the network of Centres for the Evaluation of and Information on drug Dependence (Centres d’Evaluation et d’Information sur la Pharmacodépendance - CEIP-A). Analysis of these cases showed that it concerned patients in a serious medical situation, requiring repeated use of EMONO in hospital, and that a certain number of these subjects suffered from severe Sickle-Cell Disease (SCD)

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Summary

Introduction

The use of analgesics can lead to cases of drug abuse and dependence. It can cause pseudoaddiction in patients suffering from pain. 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. Equimolar Mixture of Oxygen and Nitrous Oxide (EMONO) is a gas mixture that contains equal parts of each It has Marketing Authorization (MA) in France since 2001. Cases of severe abuse and dependence to EMONO have been declared to the French addiction monitoring system via the network of Centres for the Evaluation of and Information on drug Dependence (Centres d’Evaluation et d’Information sur la Pharmacodépendance - CEIP-A) Analysis of these cases showed that it concerned patients in a serious medical situation, requiring repeated use of EMONO in hospital, and that a certain number of these subjects suffered from severe Sickle-Cell Disease (SCD). A specific data collection in these subjects was needed

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