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.

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.

Do abused young children feel less pain?

The objective of this study was to investigate whether acute pain in abused children was under recognized by doctors and nurses compared to children evaluated for accidental injuries. We hypothesize that an abused child's reaction to physical pain could be an additional symptom of this challenging diagnosis. For the observational prospective case control study in an emergency department, children were eligible when: younger than six years old, the reported trauma occurred within the previous seven days, the trauma comprised a bone injury or burn, and the child was able to express his or her pain. The case group comprised children for whom the medical team reported their abuse suspicions and supporting information to a court, and whose cases of abuse were subsequently confirmed. The control group consisted of children with a plausible cause for their injury and no obvious signs of abuse. The children were matched according to their age and type of trauma. The pain was assessed by doctors and nurses before analgesic administration using a certified pain scale. Among the 78 included children, pain was significantly less recognized in the abused children vs. the controls (relative risk=0.63; 95% CI: 0.402-0.986; p=0.04). We observed a discrepancy between the nurses' and doctors' scores for the pain assessments (Kappa coefficient=0.59, 95% CI: 0.40-0.77). Our results demonstrate that pain expression in abused children is under recognized by medical staff. They also suggest that abused children may have reduced pain expression after a traumatic event. Paying particular attention to the pain of abused children may also optimize the analgesic treatment.