A form to report pain assessment and monitoring in the oncology clinical record: a Delphi process.

Background: Treatment of cancer pain remains suboptimal worldwide. In Italy, a law requires that pain be regularly assessed and reported in both medical and nursing records. Aim: To provide a homogeneous form to get exhaustive clinical information in the clinical report according to Italian legislation. Methods: A board, including oncologists and pain therapists, designed a form to report the pain characteristics of cancer patients in Italy in clinical records. The form was voted on through a Delphi process among directors of 18 clinical oncology specialization schools in Italy to obtain agreement on its content. Results: A form useful for collecting and reporting comprehensive and homogeneous information on pain among oncologists in Italy was produced. Conclusion: The development of common strategies for pain management can be improved by using this tool.

Adverse Drug Reactions Related to Mood and Emotion in Pediatric Patients Treated for Attention Deficit/Hyperactivity Disorder: A Comparative Analysis of the US Food and Drug Administration Adverse Event Reporting System Database.

BACKGROUND: Attention deficit/hyperactivity disorder (ADHD) can be comorbid with frequent anxiety and mood disorders, as well as emotional symptoms (anxiety, irritability, mood lability). These may also be triggered by drugs and appear as adverse drug reactions (ADRs). METHODS: We mined data from the US Food and Drug Administration Adverse Event Reporting System pharmacovigilance database, focused on methylphenidate, atomoxetine, amphetamine, lisdexamfetamine, and their derivatives. We collected reports of ADRs connected with mood or emotional symptoms in pediatric patients, excluding drug abuse/accidents. Reporting odds ratios (RORs) were calculated and compared between drug classes and children/adolescents. RESULTS: We collected 6176 ADRs of interest of which 59% occurred in children. Atomoxetine accounted for 50.7% of reports, methylphenidate for 32.5%, lisdexamfetamine for 14.2%, and amphetamine for 2.6%. Irritability, anxiety, obsessive thoughts, depressed mood, and euphoria scored significant RORs for all drugs, overall with an increasing risk from methylphenidate to atomoxetine, lisdexamfetamine, and amphetamine. Apathy regarded mostly atomoxetine, and crying regarded all drugs except methylphenidate. Several age-based differences were found. Notably, affect lability hit only adolescents. All drugs scored significant self-injury RORs, except lisdexamfetamine in adolescents, with an increasing risk from methylphenidate to lisdexamfetamine, atomoxetine, and amphetamine. For suicidality, all drugs had significant RORs in children, and methylphenidate was better than atomoxetine and lisdexamfetamine. In adolescents, only methylphenidate and atomoxetine scored significant RORs. CONCLUSIONS: We conclude that real-world data from the US Food and Drug Administration Adverse Event Reporting System are consistent with previous evidence from meta-analyses. They support a hierarchy of drug safety for several ADRs (except self-injury/suicidality) with methylphenidate as safest, followed by atomoxetine, lisdexamfetamine, and amphetamine last. Self-injury and suicidality RORs were overall higher in children.

Central nervous system-active drug abused and overdose in children: a worldwide exploratory study using the WHO pharmacovigilance database.

Recent epidemiological studies have reported an increase in central nervous system (CNS)-active drug abuse rates in paediatric settings, raising several public health concerns. No study to date has explored this issue worldwide. We performed an extensive analysis of drugs abuse/overdose reported for children in the last decade by using the largest pharmacovigilance database, i.e. the VigiBase, collecting adverse drug reaction reports that involved at least one suspect drug belonging to the Anatomical Therapeutic Chemical code "Nervous System" through the Standardised Medical Dictionary for Drug Regulatory Affairs Queries for Drug abuse. 8.682 reports matched our criteria. An increase in reporting activity was observed, starting from 2014; an intentional overdose was reported more frequently than an accidental one, with a difference between age groups. We retrieved 997 reports with death outcome. These referred more to adolescents (n = 538) than subjects of any other paediatric age group. Paracetamol and opioid analgesics were the most common suspect drugs in deaths across all age groups due to hypoxic-ischaemic encephalopathy, brain death, and cardio-respiratory arrest.Conclusion: The number of reports associated with drug abuse and overdose is increasing (for opioid and paracetamol-containing products) and a considerable number of adverse drug reactions are serious. Data on the patterns of use of such medicines from each country may help in implementing strategies of risk-minimisation and renewing healthcare recommendations worldwide. An increased clinical awareness of drug abuse and overdose is warranted, while continuing to provide effective treatments. What is Known: • The large increase in paediatric prescriptions for CNS-active drugs in the last 20 years has recently raised public health concerns about drug abuse and overdose. • No study to date has examined this issue in paediatric patients worldwide. What is New: • The number of paediatric reports associated with CNS drug abuse and intentional overdose is increasing, including those with fatal outcome; over 4 years; more than 35% of the reports was entered from European countries. • Opioid and paracetamol were most frequently suspected for ADRs with fatal outcome across all age groups, due to hypoxic-ischaemic encephalopathy and cardio-respiratory arrest, suggesting the need to implement strategies of risk-minimisation.

Severe acquired brain injury aetiologies, early clinical factors, and rehabilitation outcomes: a retrospective study on pediatric patients in rehabilitation.

Objective: Studies on pediatric severe acquired brain injury (sABI) outcomes focused mostly on single etiologies, not clarifying the independent role of clinical factors, and scantly explored inter-dependence between variables. We assessed associations of clinical factors at admission with essential outcomes, controlling for inter-dependence and sABI etiology. Methods: We reviewed the clinical records of 280 patients with traumatic and 292 with non-traumatic sABI, discharged from intensive care to pediatric neurological rehabilitation. We analyzed the distribution of clinical factors based on sABI etiology; conducted a factor analysis of variables; built multivariate models evaluating the associations of variables with death, persistent vegetative states, duration of coma, GOS outcome, length of stay. Results: We described the study sample. Factor analysis of inter-dependence between GCS, time before rehabilitation, dysautonomia, device use, produced the indicators "injury severity" and "neurological dysfunction", independent from sABI etiology, age, sex, and admittance GOS. Multivariate analyzes showed that: coma duration, GOS outcome, and length of stay, which may depend on rehabilitation courses, were directly associated with injury severity, neurological dysfunction, and patients' age; death and persistent vegetative states were also associated with etiology. Conclusion: Future studies should analyze larger cohorts and investigate mechanisms linking specific etiologies and patients' age with outcomes.

Use of a checklist to improve pain control in hospitalized cancer patients: the 38Checkpain project.

AIM: Checklists may improve management of patients in different settings. However, no studies have been conducted to investigate the use of this tool to improve inpatient pain control. This study, conducted in Italy, aims to describe the experience, in terms of pain control, of the widespread introduction of a checklist for pain control in oncological patients, according to current Italian legislation. MATERIALS & METHODS: In total, 92 Italian centers were randomly assigned to the use of the 38Checkpain to monitor pain management or to continue their standard practice without the use of this tool. RESULTS: The 38Checkpain improved the control of pain compared with centers who did not use this tool. CONCLUSION: Overall, the findings of this study suggest that the application of the 38Checkpain may help improve control of pain of hospitalized oncological patients.

Enalapril Associated with Furosemide Induced Acute Kidney Injury in an Infant with Heart Failure. A Case Report, a Revision of the Literature and a Pharmacovigilance Database Analysis.

The use of angiotensin converting enzyme (ACE) inhibitors in combination with diuretics is a common strategy used for the treatment of patients affected by heart failure. An infant affected by initial congestive cardiac failure, after starting the treatment with enalapril in association with furosemide, developed acute kidney injury (AKI). No underlying renal disease or renal artery stenosis was found. He recovered from kidney injury after the therapy was suspended, thus suggesting that the drug combination is responsible for the onset of the adverse reaction. The present case report, the appraisal of the current knowledge on the onset of AKI and the analysis of available pharmacovigilance databases indicate that particular caution should be exercised when infants affected by heart failure are treated with the enalapril and furosemide combination therapy. Moreover, we strongly suggest an up-to-date revision of the ACE-inhibitor dosing guidelines in pediatric patients to define unambiguously the safe upper limits of this class of drugs.

COVID-19 and Pregnancy: An Updated Review about Evidence-Based Therapeutic Strategies.

The COVID-19 pandemic posed a significant challenge for clinicians in managing pregnant women, who were at high risk of virus transmission and severe illness. While the WHO declared in May 2023 that COVID-19 is no longer a public health emergency, it emphasized that it remains a global health threat. Despite the success of vaccines, the possibility of new pandemic waves due to viral mutations should be considered. Ongoing assessment of the safety and effectiveness of pharmacological therapies is crucial in clinical practice. This narrative review summarizes the evidence-based therapeutic strategies for pregnant women with COVID-19, considering over three years of pandemic experience. The review discusses the safety and effectiveness of various drug regimens (antivirals, anticoagulants, corticosteroids, immunoglobulins, monoclonal antibodies, and therapeutic gases) and procedures (prone positioning and extracorporeal membrane oxygenation). Drugs with contraindications, inefficacy during pregnancy, or unknown adverse effects were excluded from our evaluation. The aim is to provide healthcare professionals with a comprehensive guide for managing pregnant women with COVID-19 based on lessons learned from the pandemic outbreak.

Effectiveness and safety of available treatments for COVID-19 during pregnancy: a critical review.

BACKGROUND: COVID-19 is a pandemic disease caused by the SARS-CoV-2 and it spread globally in the last few months. The complete lack of specific treatment forced clinicians to use old drugs, chosen for their efficacy against similar viruses or their in vitro activity. Trials on patients are ongoing but the majority of information comes from small case series and single center reports. We aimed to provide a literature review on the putative effectiveness and safety of available treatments for COVID-19 in pregnant women. METHODS: We reviewed all the available literature concerning the drugs that have been used in the treatment of COVID-19 during pregnancy and whose safe assumption during pregnancy had been demonstrated by clinical studies (i.e. including studies on other infectious diseases). Drugs contra-indicated during pregnancy or with unknown adverse effects were not included in our review. RESULTS AND CONCLUSIONS: Clinical trials are not often conducted among pregnant patients for safety reasons and this means that drugs that may be effective in general population cannot be used for pregnant women due to the lack of knowledge of side effects in this category of people .The choice to use a specific drug for COVID-19 in pregnancy should take into account benefits and possible adverse events in each single case. In the current situation of uncertainty and poor knowledge about the management of COVID-19 during pregnancy, this present overview may provide useful information for physicians with practical implications.

Recommendations for analgesia and sedation in critically ill children admitted to intensive care unit.

We aim to develop evidence-based recommendations for intensivists caring for children admitted to intensive care units and requiring analgesia and sedation. A panel of national paediatric intensivists expert in the field of analgesia and sedation and other specialists (a paediatrician, a neuropsychiatrist, a psychologist, a neurologist, a pharmacologist, an anaesthesiologist, two critical care nurses, a methodologist) started in 2018, a 2-year process. Three meetings and one electronic-based discussion were dedicated to the development of the recommendations (presentation of the project, selection of research questions, overview of text related to the research questions, discussion of recommendations). A telematic anonymous consultation was adopted to reach the final agreement on recommendations. A formal conflict-of-interest declaration was obtained from all the authors. Eight areas of direct interest and one additional topic were considered to identify the best available evidence and to develop the recommendations using the Evidence-to-Decision framework according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. For each recommendation, the level of evidence, the strength of the recommendation, the benefits, the harms and the risks, the benefit/harm balance, the intentional vagueness, the values judgement, the exclusions, the difference of the opinions, the knowledge gaps, and the research opportunities were reported. The panel produced 17 recommendations. Nine were evaluated as strong, 3 as moderate, and 5 as weak. Conclusion: a panel of national experts achieved consensus regarding recommendations for the best care in terms of analgesia and sedation in critically ill children.

Levetiracetam Improves Upper Limb Spasticity in a Patient With Unresponsive Wakefulness Syndrome: A Case Report.

Severe spasticity is a frequent and disabling complication in patients presenting disorders of consciousness (DOC) that hinders their rehabilitative process, and is strongly correlated with pain reducing patients' quality of life. In these patients, abnormal postures may occur as an expression of severe brain damage. Here we present the case of a 52-year-old man in decorticate rigidity following a hypoxic-ischemic encephalopathy due to myocardial infarction who showed improvement of spasticity of upper limbs following intake of levetiracetam combined with the conventional neurorehabilitation program.

Topical treatment of radiation-induced dermatitis: current issues and potential solutions.

Approximately 95% of patients receiving radiotherapy (RT) will ultimately develop radiation-induced dermatitis (RID) during or after the course of treatment, with major consequences on quality of life and treatment outcomes. This paper reviews the pathophysiology of RID and currently used topical products for the prevention and treatment of RID. Although there is no consensus on the appropriate management, recent evidence suggests that the use of topical products supports to protect and promote tissue repair in patients with RID. Basic recommendations include advice to wear loose clothing, using electric razors if necessary, and avoiding cosmetic products, sun exposure or extreme temperatures. Based on mechanisms involved and on the clinical characteristics of oncological patients, the profile of the ideal topical product for addressing RID can be designed; it should have limited risk of adverse events, systemic adsorption and drug-drug interactions, should be characterized by multiple clinical activities, with a special focus on localized pain, and should have a careful formulation as some vehicles can block the RT beam.