Prevalence of Problematic Use of Equimolar Mixture of Oxygen and Nitrous Oxide and Analgesics in the Sickle-cell Disease
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Observational

Summary: 
      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.

      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.

      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.
    

Detailed description: 
      This is a national multicentric observational study

      •Clinical assessment

      After he includes a patient, the medical practitioner complete a clinical assessment which
      contains all information about patient's family and personal history, history of the SCD and
      treatment already received for SCD. The clinical assessment is kept in the Reference Centre
      or Special Centre for Children and Adults (RSCCA). Therefore, the trained researcher will
      schedule a visit to the RSCCA to retrieve the clinical assessments of all patients included
      in this RSCCA and enter the data in the electronic case report form (e-CRF).

        -  Telephone interview

      Telephone interview is carried out with a trained researcher from Nantes CEIP-A. When Nantes
      CEIP-A receipts the inclusion form and written consent, the trained researcher schedules a
      telephone interview with the patient. The interview is suited to the child's, adolescent's or
      young adult's age, maturity and comprehension skills. The following parameters are evaluated
      during the telephone semi-structured interview for EMONO, and for other analgesic drugs,
      during pain episodes and outside pain episodes.
    

Intervention name(s): telephone interview
Intervention type(s): Other
Intervention description(s): Clinical assessment for screening and a phone call for questionnaire administration
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        French sickle-cell disease population who has a problematic use of Equimolar Mixture of
        Oxygen and Nitrous Oxide (EMONO) and analgesics
      
Keywords: sickle cell disease