119 Experiences of Grief by Pediatric Intensive Care Nurses in Padua University Hospital: An Exploratory Study

AbstractA practical guidance on the management of children with COVID-19 to insure homogeneous criteria for referral to a higher-level facility, according to the disease severity, is pivotal in the pandemic era. A panel of experts in pediatric infectious diseases and intensive care at the tertiary-care Meyer Children’s University Hospital, Florence, Italy, issued a practical document shared with Tuscany hospitals. The rationale was to target the referral for those children at risk of requiring an intensive support, since the above mentioned hospital has the pediatric intensive care unit. Overall, 378 patients between 0 and 19 years of age were diagnosed with COVID-19 infection in the Tuscany region with 24 (6.3%) hospitalizations. Only three children were centralized to Meyer Children’s University Hospital according to reported criteria. Considering that appropriate referral criteria have been associated with reduced mortality in other conditions, our document might be useful to improve outcomes of children with COVID-19.

Download Full-text

Efficacy and safety of dexmedetomidine for prevention of withdrawal syndrome in the pediatric intensive care unit: protocol for an adaptive, multicenter, randomized, double-blind, placebo-controlled, non-profit clinical trial

Trials ◽

10.1186/s13063-019-3793-6 ◽

2019 ◽

Vol 20 (1) ◽

Cited By ~ 1

Author(s):

Maria Cristina Mondardini ◽

Francesca Sperotto ◽

Marco Daverio ◽

Fabio Caramelli ◽

Dario Gregori ◽

...

Keyword(s):

Intensive Care Unit ◽

Intensive Care ◽

Pediatric Intensive Care Unit ◽

Withdrawal Syndrome ◽

Clinical Signs ◽

Pediatric Intensive Care ◽

University Hospital ◽

Prolonged Treatment ◽

Double Blind ◽

Double Blind Placebo

Abstract Background Prolonged treatment with analgesic and sedative drugs in the pediatric intensive care unit (PICU) may lead to undesirable effects such as dependence and tolerance. Moreover, during analgosedation weaning, patients may develop clinical signs of withdrawal, known as withdrawal syndrome (WS). Some studies indicate that dexmedetomidine, a selective α2-adrenoceptor agonist, may be useful to prevent WS, but no clear evidence supports these data. The aims of the present study are to evaluate the efficacy of dexmedetomidine in reducing the occurrence of WS during analgosedation weaning, and to clearly assess its safety. Methods We will perform an adaptive, multicenter, randomized, double-blind, placebo-controlled trial. Patients aged < 18 years receiving continuous intravenous analgosedation treatment for at least 5 days and presenting with clinical conditions that allow analgosedation weaning will be randomly assigned to treatment A (dexmedetomidine) or treatment B (placebo). The treatment will be started 24 h before the analgosedation weaning at 0.4 μg/kg/h, increased by 0.2 μg/kg/h per hour up to 0.8 μg/kg/h (neonate: 0.2 μg/kg/h, increased by 0.1 μg/kg/h per hour up to 0.4 μg/kg/h) and continued throughout the whole weaning time. The primary endpoint is the efficacy of the treatment, defined by the reduction in the WS rate among patients treated with dexmedetomidine compared with patients treated with placebo. Safety will be assessed by collecting any potentially related adverse event. The sample size assuring a power of 90% is 77 patients for each group (total N = 154 patients). The study was approved by the Ethics Committee of the University-Hospital S.Orsola-Malpighi of Bologna on 22 March 2017. Discussion The present trial will allow us to clearly assess the efficacy of dexmedetomidine in reducing the occurrence of WS during weaning from analgosedation drugs. In addition, the study will provide a unique insight into the safety profile of dexmedetomidine. Trial registration ClinicalTrials.gov, NCT03645603. Registered on 24 August 2018. EudraCT, 2015–002114-80. Retrospectively registered on 2 January 2019.

Download Full-text

Efficacy and safety of Dexmedetomidine for prevention of withdrawal syndrome in Pediatric Intensive Care Unit: protocol for an adaptive, multicenter, randomized, double blind, placebo-controlled, non-profit clinical trial

10.21203/rs.2.491/v2 ◽

2019 ◽

Author(s):

Maria Cristina Mondardini ◽

Francesca Sperotto ◽

Marco Daverio ◽

Fabio Caramelli ◽

Dario Gregori ◽

...

Keyword(s):

Intensive Care Unit ◽

Intensive Care ◽

Pediatric Intensive Care Unit ◽

Withdrawal Syndrome ◽

Clinical Signs ◽

Pediatric Intensive Care ◽

University Hospital ◽

Prolonged Treatment ◽

Double Blind ◽

Double Blind Placebo

Abstract Background: Prolonged treatment with analgesic and sedative drugs in Pediatric Intensive Care Unit (PICU) may lead to undesirable effects as dependence and tolerance. Moreover, during the analgosedation weaning patients may develop clinical signs of withdrawal, known as withdrawal syndrome (WS). Some studies indicated that dexmedetomidine, a selective α2-adrenoceptors agonist, may be useful to prevent WS, but no clear evidences support this data. Aims of the present study are to evaluate the efficacy of dexmedetomidine in reducing the occurrence of WS during the analgosedation weaning, and to clearly assess its safety. Methods: We will perform an adaptive, multicenter, randomized, double-blind, placebo-controlled trial. Patients <18 years receiving a continuous intravenous analgosedation treatment for at least 5 days and presenting with clinical conditions that allows the analgosedation weaning will be randomly assigned to treatment A (dexmedetomidine) or treatment B (placebo). The treatment will be started 24 hours before the analgosedation-weaning at 0.4 mcg/kg/h, increased of 0.2 mcg/kg/h per hour up to 0.8 mcg/Kg/h (neonate: 0.2 mcg/Kg/h, increased of 0.1 mcg/Kg/h per hour up to 0.4 mcg/Kg/h)and continued throughout the whole weaning-time. The primary endpoint is the efficacy of the treatment, defined by the reduction in WS rate among patients treated with dexmedetomidine comparing with patients treated with placebo. Safety will be assessed collecting any potentially-related adverse event. The sample size assuring a power of 90% is 77 patients for each group (N total=154 patients). The study was approved by the Ethics Committee of the University-Hospital S.Orsola-Malpighi of Bologna on 22 March 2017. Discussion: The present trial will allow to clearly assess the efficacy of dexmedetomidine in reducing the occurrence of WS during the weaning of analgosedation drugs. In addition, the study will provide a unique insight into the safety profile of dexmedetomidine. Trial registration: AIFA ID TIP-15-01.ClinicalTrials.govID NCT03645603, registered on 24 August 2018. Retrospectively registered on EudraCT with ID 2015-002114-80 on 2 Jan 2019.

Download Full-text