scholarly journals Efficacy and safety of Dexmedetomidine for prevention of withdrawal syndrome in Pediatric Intensive Care Unit Protocol for a prospective, multicenter, randomized, double blind, placebo-controlled, non-profit clinical trial (TIP-15-01)

2019 ◽  
Author(s):  
Maria Cristina Mondardini ◽  
Giorgio Conti ◽  
Fabio Caramelli ◽  
Francesca Sperotto ◽  
Marco Daverio ◽  
...  
Keyword(s):  
Intensive Care Unit ◽  
Intensive Care ◽  
Pediatric Intensive Care Unit ◽  
Withdrawal Syndrome ◽  
Dose Range ◽  
Pediatric Intensive Care ◽  
Prolonged Treatment ◽  
Controlled Study ◽  
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 still 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, to evaluate its safety, to identify its optimal dose-range and to quantify its ability in reducing time of weaning, time of mechanical ventilation and PICU-stay. Methods: We will perform a prospective, multicenter, randomized, double-blind, placebo-controlled study. Patients meeting the inclusion criteria will be randomly assigned to treatment A (dexmedetomidine) or treatment B (placebo). Treatments will be started 24 hours before the analgosedation-weaning and will be continued throughout the whole weaning time. Efficacy of treatments will be evaluated by monitoring the signs of WS using the withdrawal assessment tool version 1 score (WAT-1). If WAT-1 score is ≥3, dexmedetomidine/placebo-dose will be increased following a defined protocol. Thus, efficacy will be compared between treatment groups. Safety will be assessed collecting any potentially-related adverse event. Clinical or sedation characteristics will be analyzed to assess any significant association with outcome measures. The sample size assuring a power of 95% is 80 patients for each group (N total=160 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: ClinicalTrials.gov ID NCT03645603, registered on 24 August 2018, https://clinicaltrials.gov/ct2/show/NCT03645603. Retrospectively registered on EudraCT with ID 2015-002114-80, registered on 2 Jan 2019.

scholarly journals 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 ◽  
2019 ◽  
Vol 20 (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.

scholarly journals 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

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.

scholarly journals 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

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.

scholarly journals Prospective Randomized Double-Blind Placebo Controlled Trial of Recombinant Human Erythropoietin Administration to Reduce Blood Transfusions in Anemic Pediatric Intensive Care Patients

2006 ◽  
Vol 11 (2) ◽  
pp. 101-106 ◽  
Author(s):  
Michael F. Chicella ◽  
Kem P. Krueger
Keyword(s):  
Intensive Care Unit ◽  
Intensive Care ◽  
Pediatric Intensive Care Unit ◽  
Recombinant Human Erythropoietin ◽  
Reticulocyte Count ◽  
Controlled Trial ◽  
Pediatric Intensive Care ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Human Erythropoietin

OBJECTIVE The purpose of this study was to determine if the number of red blood cell (RBC) transfusions anemic pediatric intensive care unit patients receive could be reduced by the prophylactic administration of recombinant human erythropoietin (rHuEPO). METHODS This was a randomized, double-blind placebo controlled trial. Patients were randomized to receive either intravenous rHuEPO 300 units/kg/day or placebo. Both groups received elemental iron 6 mg/kg/day. RESULTS Twenty-seven patients, ages 1 month to 13 years, were enrolled. Baseline hematocrit (Hct), reticulocyte count, and erythropoietin concentration were similar between the two groups. Three patients randomized to rHuEPO received 1 RBC transfusion each, and 4 patients randomized to placebo received 9 transfusions total (P = .68). The end-of-study Hct was not significantly different between the rHuEPO and placebo groups, 30.3 ± 3.6 and 26.8 ± 4.8, respectively (P = .06). Additionally, neither the % Hct change (baseline to final), nor the % reticulocyte change (baseline to final), was statistically different between the two groups. CONCLUSION In this small group of anemic pediatric intensive care unit patients, prophylactic rHuEPO administration did not reduce the number of patients who received RBC transfusions. Furthermore, it did not significantly increase Hct or reticulocyte count when compared to placebo.

774: WITHDRAWAL SYNDROME INCIDENCE AND RISK FACTORS IN A PEDIATRIC INTENSIVE CARE UNIT

2016 ◽  
Vol 44 (12) ◽  
pp. 269-269
Author(s):  
Kristie Rodriguez-Otero ◽  
Anabel Puig-Ramos ◽  
Carlos Lopez-Ortiz ◽  
Samuel Pabon-Rivera ◽  
Gabriel De Jesus-Astacio ◽  
...  
Keyword(s):  
Risk Factors ◽  
Intensive Care Unit ◽  
Intensive Care ◽  
Pediatric Intensive Care Unit ◽  
Withdrawal Syndrome ◽  
Pediatric Intensive Care

scholarly journals Dexmedetomidine and Iatrogenic Withdrawal Syndrome in Critically Ill Children

2021 ◽  
Vol 41 (1) ◽  
pp. e17-e23
Author(s):  
Barbara M. Geven ◽  
Jolanda M. Maaskant ◽  
Catherine S. Ward ◽  
Job B.M. van Woensel
Keyword(s):  
Intensive Care Unit ◽  
Intensive Care ◽  
Pediatric Intensive Care Unit ◽  
Cumulative Dose ◽  
Withdrawal Syndrome ◽  
Significant Risk ◽  
Pediatric Intensive Care ◽  
Significant Risk Factor ◽  
Preventive Effect ◽  
Iatrogenic Withdrawal Syndrome

Background Iatrogenic withdrawal syndrome is a well-known adverse effect of sedatives and analgesics commonly used in patients receiving mechanical ventilation in the pediatric intensive care unit, with an incidence of up to 64.6%. When standard sedative and analgesic treatment is inadequate, dexmedetomidine may be added. The effect of supplemental dexmedetomidine on iatrogenic withdrawal syndrome is unclear. Objective To explore the potentially preventive effect of dexmedetomidine, used as a supplement to standard morphine and midazolam regimens, on the development of iatrogenic withdrawal syndrome in patients receiving mechanical ventilation in the pediatric intensive care unit. Methods This retrospective observational study used data from patients on a 10-bed general pediatric intensive care unit. Iatrogenic withdrawal syndrome was measured using the Sophia Observation withdrawal Symptoms-scale. Results In a sample of 102 patients, the cumulative dose of dexmedetomidine had no preventive effect on the development of iatrogenic withdrawal syndrome (P = .19). After correction for the imbalance in the baseline characteristics between patients who did and did not receive dexmedetomidine, the cumulative dose of midazolam was found to be a significant risk factor for iatrogenic withdrawal syndrome (P &lt; .03). Conclusion In this study, supplemental dexmedetomidine had no preventive effect on iatrogenic withdrawal syndrome in patients receiving sedative treatment in the pediatric intensive care unit. The cumulative dose of midazolam was a significant risk factor for iatrogenic withdrawal syndrome.

Computerized Dose Range Checking Using Hard and Soft Stop Alerts Reduces Prescribing Errors in a Pediatric Intensive Care Unit

2017 ◽  
Vol 13 (3) ◽  
pp. 144-148 ◽  
Author(s):  
Lilanthi Balasuriya ◽  
David Vyles ◽  
Paul Bakerman ◽  
Vanessa Holton ◽  
Vinay Vaidya ◽  
...  
Keyword(s):  
Intensive Care Unit ◽  
Intensive Care ◽  
Pediatric Intensive Care Unit ◽  
Dose Range ◽  
Pediatric Intensive Care ◽  
Prescribing Errors

Withdrawal syndrome in the pediatric intensive care unit. Incidence and risk factors

2013 ◽  
Vol 37 (2) ◽  
pp. 67-74 ◽  
Author(s):  
F. Fernández-Carrión ◽  
M. Gaboli ◽  
R. González-Celador ◽  
P. Gómez de Quero-Masía ◽  
S. Fernández-de Miguel ◽  
...  
Keyword(s):  
Risk Factors ◽  
Intensive Care Unit ◽  
Intensive Care ◽  
Pediatric Intensive Care Unit ◽  
Withdrawal Syndrome ◽  
Pediatric Intensive Care
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