<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03760978</url>
  </required_header>
  <id_info>
    <org_study_id>4466/AO/18; AOP1403</org_study_id>
    <nct_id>NCT03760978</nct_id>
  </id_info>
  <brief_title>Dexmedetomidine for Prolonged Sedation in PICUs</brief_title>
  <acronym>PROSDEX</acronym>
  <official_title>Efficacy and Safety of Dexmedetomidine for Prolonged Sedation in Pediatric Intensive Care Units</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Ospedaliera di Padova</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>IRCCS Azienda Ospedaliero-Universitaria di Bologna</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Azienda Ospedaliera di Padova</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sedation management of the critically ill patients is still a challenge for the pediatric&#xD;
      intensivists. Worldwide the most common sedation approach includes the concomitant use of&#xD;
      opioids and benzodiazepines. The use of these drugs is associated with adverse events&#xD;
      contributing with morbidity, such as decreased spontaneous ventilation, withdrawal syndrome&#xD;
      and delirium onset. Moreover, benzodiazepine demonstrated a neurotoxic apoptotic effect that&#xD;
      could potentially impact neurocognitive outcome.&#xD;
&#xD;
      Dexmedetomidine (DEX) is a selective alpha-2-adrenergic agonist with sedative, analgesic and&#xD;
      anxiolytic effects. Its unique pharmacological profile allows reaching a conscious sedation&#xD;
      state with minimal respiratory depression, promoting faster ventilation weaning and better&#xD;
      collaboration with the medical staff. Moreover, DEX seems to present adjuvant properties&#xD;
      towards withdrawal syndrome and delirium. Finally, some studies in animals suggested that&#xD;
      Dexmedetomidine might have a role of neuro-protection, especially in a contest of cerebral&#xD;
      ischemia.&#xD;
&#xD;
      Currently, the Food and Drug Administration (FDA) and the European Medicines Agency (EMA)&#xD;
      approved DEX only for the adult population and for sedation lasting not more than 24 hours.&#xD;
      The Italian Medicines Agency (AIFA), in January 2016, approve DEX in children for specific&#xD;
      indications including difficult sedation in mechanically ventilated critically ill patients.&#xD;
      Up to now, few data are still available regarding its efficacy and safety for prolonged&#xD;
      sedation in Pediatric Intensive Care Units (PICUs) and no studies have reported the use of&#xD;
      DEX after AIFA's approval so far.&#xD;
&#xD;
      Aims of the study are:&#xD;
&#xD;
      to evaluate the characteristics of DEX use for prolonged sedation ≥24 hours in critically ill&#xD;
      children (indication, dosages, time of infusion, time of infusion weaning, association with&#xD;
      other drugs); to evaluate its efficacy in terms of comfort and conventional drug sparing,&#xD;
      using standardized and validate measures; further, to evaluate its efficacy in terms of&#xD;
      reduction of incidence of withdrawal syndrome and delirium; to evaluate its safety profile&#xD;
      collecting any adverse event potentially correlated with its administration; to define if&#xD;
      efficacy and safety could differ among approved indications versus not-approved ones.&#xD;
&#xD;
      Design: Multicenter observational prospective study, involving tertiary-care PICUs.&#xD;
&#xD;
      Study period: From January 2016 up to reaching of the calculated sample size (N patients&#xD;
      =163).&#xD;
&#xD;
      Population: All critically ill patients &lt;18 years who received prolonged sedation including&#xD;
      DEX for ≥24 hours. In case of multiple infusions, only data regarding the first infusion will&#xD;
      be included. Exclusion criteria: extreme prematurity (&lt;28 weeks of gestational age),&#xD;
      hypersensitivity to the active substance, incomplete data form. .&#xD;
&#xD;
      Collecting data strategy: Data will be prospectively collected from each Institution by means&#xD;
      of a anonymous standardized form completed by two different investigators per center. For&#xD;
      each patient, the following variables will be collected:&#xD;
&#xD;
      demographics characteristics (age, gender, race, weight) and clinical features (main&#xD;
      diagnosis, associated morbidities, PIM3 score ad admission, number of high intensity&#xD;
      interventions during PICU-stay, mechanical ventilation features, inotropic drugs use, length&#xD;
      of stay, survival at discharge); DEX administration characteristics (indication, loading&#xD;
      dose, minimum and maximum dosages, duration of DEX infusion, duration of DEX infusion&#xD;
      weaning) and information on concomitant use of analgesics or sedative drugs (name of drugs&#xD;
      and respective dosages at DEX starting time and 24 hours later); clinical scores of analgesia&#xD;
      and sedation (Comfort Behavior Scale, CBS), withdrawal syndrome (Withdrawal Assessment&#xD;
      Toll-1, WAT-1) and delirium (Cornell Assessment of Pediatric Delirium, CAPD) depending on the&#xD;
      respective indication, registered immediate pre-DEX and 24 hours later; any adverse event&#xD;
      potentially related to DEX administration and any related intervention, if present. In&#xD;
      particular, we the investigators evaluate if bradycardia, hypotension (with or without poor&#xD;
      perfusion), hypertension, agitations or other events are registered during the infusion.&#xD;
      Further, investigators will register if any sign of DEX withdrawal (tachycardia,&#xD;
      hypertension, agitation, other) are present immediately after the infusion.&#xD;
&#xD;
      Statistical analysis: Descriptive and analytic statistics will be performed according with&#xD;
      the variable characteristics. A causal multivariate model will be developed to identify any&#xD;
      significant risk or protective factors towards adverse outcomes (ineffective sedation, onset&#xD;
      of adverse events).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Comfort Behavior Scale (CBS)</measure>
    <time_frame>Immediately before DEX start and 24 hours later</time_frame>
    <description>Standardized validated score for sedation level and pain assessment; range 6-30; lower values represent a deep level of sedation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Opioid and benzodiazepines dosage</measure>
    <time_frame>Immediately before DEX start and 24 hours later.</time_frame>
    <description>Opioid and benzodiazepines cumulative and maximal dosage</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Withdrawal Assessment Tool-1</measure>
    <time_frame>Immediately before DEX start and 24 hours later.</time_frame>
    <description>Standardized validated score for the assessment of withdrawal syndrome; range 0-12; higher values represent a more severe withdrawal syndrome; withdrawal syndrome is probable if score is &gt; 2</description>
  </other_outcome>
  <other_outcome>
    <measure>Cornell Assessment of Pediatric Delirium, CAPD</measure>
    <time_frame>Immediately before DEX start and 24 hours later</time_frame>
    <description>Standardized validated score for the assessment of pediatric delirium; range 0-32; higher scores represent a more severe presence of delirium; delirium is probable if score is &gt; 8</description>
  </other_outcome>
  <other_outcome>
    <measure>Onset of adverse events</measure>
    <time_frame>During and immediately after dexmedetomidine infusion.</time_frame>
    <description>any adverse event potentially related with DEX-administration</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">163</enrollment>
  <condition>Prolonged Sedation</condition>
  <arm_group>
    <arm_group_label>dex group</arm_group_label>
    <description>Critically ill patients &lt;18 year-old receiving prolonged sedation with endovenous dexmedetomidine (dosage 0.2 mcg/Kg/hour to 1.8 mcg/Kg/hour) more than 24 hours</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <arm_group_label>dex group</arm_group_label>
    <other_name>dexdor</other_name>
    <other_name>precedex</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Critically ill children admitted to PICU&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &lt;18 years&#xD;
&#xD;
          -  admission to PICU&#xD;
&#xD;
          -  sedation with dexmedetomidine lasted more than 24 hours&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  extreme prematurity (&lt;28 weeks of gestational age)&#xD;
&#xD;
          -  hypersensitivity to the active substance&#xD;
&#xD;
          -  incomplete data regarding outcome measures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>angela amigoni, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda Ospedaliera di Padova</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pediatric Intensive Care Unit, Children's Hospital C.Arrigo, Alessandria, Italy</name>
      <address>
        <city>Alessandria</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric Intensive Care Unit, ASST John XXIII Pope Hospital, Bergamo, Italy</name>
      <address>
        <city>Bergamo</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric Intensive Care Unit, S.Orsola Malpighi Hospital, University of Bologna, Italy</name>
      <address>
        <city>Bologna</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric Intensive Care Unit, Children's Hospital V.Buzzi, Milan, Italy</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric and Neonatal Intensive Care Unit, Maggiore della Carità Hospital, Novara, Italy</name>
      <address>
        <city>Novara</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Terapia Intensiva Pediatrica Azienda Ospedaliera di Padova</name>
      <address>
        <city>Padova</city>
        <zip>35127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric Intensive Care Unit, Bambino Gesù Children's Hospital, Rome, Italy</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric Intensive Care Unit, A.Gemelli Hospital, Sacro Cuore Catholic University, Rome Italy</name>
      <address>
        <city>Rome</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatric Intensive Care Unit, Burlo Garofalo Hospital, University of Trieste, Italy</name>
      <address>
        <city>Trieste</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <link>
    <url>http://www.sarnepi.it</url>
    <description>see Group of Study PeNPAD (Italian Research Group on Pediatric Neurological Protection and Drugs)</description>
  </link>
  <results_reference>
    <citation>Mondardini MC, Astuto M, Amigoni A. Inclusion of dexmedetomidine for pediatric indications in the list of medicinal products issued by the National Law 648/96. Minerva Anestesiol. 2017 Aug;83(8):891-892. doi: 10.23736/S0375-9393.17.11975-9. Epub 2017 Mar 3. No abstract available.</citation>
    <PMID>28256816</PMID>
  </results_reference>
  <results_reference>
    <citation>Romagnoli S, Amigoni A, Blangetti I, Casella G, Chelazzi C, Forfori F, Garisto C, Mondardini MC, Moltrasio M, Pasero D, Principi T, Ricci Z, Tarantino F, Conti G. Light sedation with dexmedetomidine: a practical approach for the intensivist in different ICU patients. Minerva Anestesiol. 2018 Jun;84(6):731-746. doi: 10.23736/S0375-9393.18.12350-9. Epub 2018 Feb 5.</citation>
    <PMID>29405671</PMID>
  </results_reference>
  <results_reference>
    <citation>Sperotto F, Mondardini MC, Vitale F, Daverio M, Campagnano E, Ferrero F, Rossetti E, Vasile B, Dusio MP, Ferrario S, Savron F, Brugnaro L, Amigoni A; Pediatric Neurological Protection and Drugs (PeNPAD) Study Group. Prolonged sedation in critically ill children: is dexmedetomidine a safe option for younger age? An off-label experience. Minerva Anestesiol. 2019 Feb;85(2):164-172. doi: 10.23736/S0375-9393.18.13062-8. Epub 2018 Oct 30.</citation>
    <PMID>30394067</PMID>
  </results_reference>
  <results_reference>
    <citation>Grant MJ, Schneider JB, Asaro LA, Dodson BL, Hall BA, Simone SL, Cowl AS, Munkwitz MM, Wypij D, Curley MA; Randomized Evaluation of Sedation Titration for Respiratory Failure Study Investigators. Dexmedetomidine Use in Critically Ill Children With Acute Respiratory Failure. Pediatr Crit Care Med. 2016 Dec;17(12):1131-1141. doi: 10.1097/PCC.0000000000000941.</citation>
    <PMID>27654816</PMID>
  </results_reference>
  <results_reference>
    <citation>Tabacco B, Tacconi C, Amigoni A. Survey on monitoring analgesia and sedation in the Italian Pediatric Intensive Care Units. Minerva Anestesiol. 2017 Oct;83(10):1010-1016. doi: 10.23736/S0375-9393.17.11707-4. Epub 2017 Mar 28.</citation>
    <PMID>28358177</PMID>
  </results_reference>
  <results_reference>
    <citation>Mason KP, Lerman J. Review article: Dexmedetomidine in children: current knowledge and future applications. Anesth Analg. 2011 Nov;113(5):1129-42. doi: 10.1213/ANE.0b013e31822b8629. Epub 2011 Aug 4.</citation>
    <PMID>21821507</PMID>
  </results_reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>January 18, 2019</last_update_submitted>
  <last_update_submitted_qc>January 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Ospedaliera di Padova</investigator_affiliation>
    <investigator_full_name>angela amigoni</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>sedation</keyword>
  <keyword>dexmedetomidine</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03760978
org study id: 4466/AO/18; AOP1403
nct id: NCT03760978
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Sedation management of the critically ill patients is still a challenge for the pediatric
      intensivists. Worldwide the most common sedation approach includes the concomitant use of
      opioids and benzodiazepines. The use of these drugs is associated with adverse events
      contributing with morbidity, such as decreased spontaneous ventilation, withdrawal syndrome
      and delirium onset. Moreover, benzodiazepine demonstrated a neurotoxic apoptotic effect that
      could potentially impact neurocognitive outcome.

      Dexmedetomidine (DEX) is a selective alpha-2-adrenergic agonist with sedative, analgesic and
      anxiolytic effects. Its unique pharmacological profile allows reaching a conscious sedation
      state with minimal respiratory depression, promoting faster ventilation weaning and better
      collaboration with the medical staff. Moreover, DEX seems to present adjuvant properties
      towards withdrawal syndrome and delirium. Finally, some studies in animals suggested that
      Dexmedetomidine might have a role of neuro-protection, especially in a contest of cerebral
      ischemia.

      Currently, the Food and Drug Administration (FDA) and the European Medicines Agency (EMA)
      approved DEX only for the adult population and for sedation lasting not more than 24 hours.
      The Italian Medicines Agency (AIFA), in January 2016, approve DEX in children for specific
      indications including difficult sedation in mechanically ventilated critically ill patients.
      Up to now, few data are still available regarding its efficacy and safety for prolonged
      sedation in Pediatric Intensive Care Units (PICUs) and no studies have reported the use of
      DEX after AIFA's approval so far.

      Aims of the study are:

      to evaluate the characteristics of DEX use for prolonged sedation ≥24 hours in critically ill
      children (indication, dosages, time of infusion, time of infusion weaning, association with
      other drugs); to evaluate its efficacy in terms of comfort and conventional drug sparing,
      using standardized and validate measures; further, to evaluate its efficacy in terms of
      reduction of incidence of withdrawal syndrome and delirium; to evaluate its safety profile
      collecting any adverse event potentially correlated with its administration; to define if
      efficacy and safety could differ among approved indications versus not-approved ones.

      Design: Multicenter observational prospective study, involving tertiary-care PICUs.

      Study period: From January 2016 up to reaching of the calculated sample size (N patients
      =163).

      Population: All critically ill patients <18 years who received prolonged sedation including
      DEX for ≥24 hours. In case of multiple infusions, only data regarding the first infusion will
      be included. Exclusion criteria: extreme prematurity (<28 weeks of gestational age),
      hypersensitivity to the active substance, incomplete data form. .

      Collecting data strategy: Data will be prospectively collected from each Institution by means
      of a anonymous standardized form completed by two different investigators per center. For
      each patient, the following variables will be collected:

      demographics characteristics (age, gender, race, weight) and clinical features (main
      diagnosis, associated morbidities, PIM3 score ad admission, number of high intensity
      interventions during PICU-stay, mechanical ventilation features, inotropic drugs use, length
      of stay, survival at discharge); DEX administration characteristics (indication, loading
      dose, minimum and maximum dosages, duration of DEX infusion, duration of DEX infusion
      weaning) and information on concomitant use of analgesics or sedative drugs (name of drugs
      and respective dosages at DEX starting time and 24 hours later); clinical scores of analgesia
      and sedation (Comfort Behavior Scale, CBS), withdrawal syndrome (Withdrawal Assessment
      Toll-1, WAT-1) and delirium (Cornell Assessment of Pediatric Delirium, CAPD) depending on the
      respective indication, registered immediate pre-DEX and 24 hours later; any adverse event
      potentially related to DEX administration and any related intervention, if present. In
      particular, we the investigators evaluate if bradycardia, hypotension (with or without poor
      perfusion), hypertension, agitations or other events are registered during the infusion.
      Further, investigators will register if any sign of DEX withdrawal (tachycardia,
      hypertension, agitation, other) are present immediately after the infusion.

      Statistical analysis: Descriptive and analytic statistics will be performed according with
      the variable characteristics. A causal multivariate model will be developed to identify any
      significant risk or protective factors towards adverse outcomes (ineffective sedation, onset
      of adverse events).
observational model: Cohort
time perspective: Prospective
measure: Comfort Behavior Scale (CBS)
time frame: Immediately before DEX start and 24 hours later
description: Standardized validated score for sedation level and pain assessment; range 6-30; lower values represent a deep level of sedation
measure: Opioid and benzodiazepines dosage
time frame: Immediately before DEX start and 24 hours later.
description: Opioid and benzodiazepines cumulative and maximal dosage
measure: Withdrawal Assessment Tool-1
time frame: Immediately before DEX start and 24 hours later.
description: Standardized validated score for the assessment of withdrawal syndrome; range 0-12; higher values represent a more severe withdrawal syndrome; withdrawal syndrome is probable if score is > 2
measure: Cornell Assessment of Pediatric Delirium, CAPD
time frame: Immediately before DEX start and 24 hours later
description: Standardized validated score for the assessment of pediatric delirium; range 0-32; higher scores represent a more severe presence of delirium; delirium is probable if score is > 8
measure: Onset of adverse events
time frame: During and immediately after dexmedetomidine infusion.
description: any adverse event potentially related with DEX-administration
arm group label: dex group
description: Critically ill patients <18 year-old receiving prolonged sedation with endovenous dexmedetomidine (dosage 0.2 mcg/Kg/hour to 1.8 mcg/Kg/hour) more than 24 hours
intervention type: Drug
intervention name: Dexmedetomidine
arm group label: dex group
other name: dexdor
other name: precedex
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
last name: angela amigoni, MD
role: Principal Investigator
affiliation: Azienda Ospedaliera di Padova
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Italy
url: http://www.sarnepi.it
description: see Group of Study PeNPAD (Italian Research Group on Pediatric Neurological Protection and Drugs)
citation: Mondardini MC, Astuto M, Amigoni A. Inclusion of dexmedetomidine for pediatric indications in the list of medicinal products issued by the National Law 648/96. Minerva Anestesiol. 2017 Aug;83(8):891-892. doi: 10.23736/S0375-9393.17.11975-9. Epub 2017 Mar 3. No abstract available.
PMID: 28256816
citation: Romagnoli S, Amigoni A, Blangetti I, Casella G, Chelazzi C, Forfori F, Garisto C, Mondardini MC, Moltrasio M, Pasero D, Principi T, Ricci Z, Tarantino F, Conti G. Light sedation with dexmedetomidine: a practical approach for the intensivist in different ICU patients. Minerva Anestesiol. 2018 Jun;84(6):731-746. doi: 10.23736/S0375-9393.18.12350-9. Epub 2018 Feb 5.
PMID: 29405671
citation: Sperotto F, Mondardini MC, Vitale F, Daverio M, Campagnano E, Ferrero F, Rossetti E, Vasile B, Dusio MP, Ferrario S, Savron F, Brugnaro L, Amigoni A; Pediatric Neurological Protection and Drugs (PeNPAD) Study Group. Prolonged sedation in critically ill children: is dexmedetomidine a safe option for younger age? An off-label experience. Minerva Anestesiol. 2019 Feb;85(2):164-172. doi: 10.23736/S0375-9393.18.13062-8. Epub 2018 Oct 30.
PMID: 30394067
citation: Grant MJ, Schneider JB, Asaro LA, Dodson BL, Hall BA, Simone SL, Cowl AS, Munkwitz MM, Wypij D, Curley MA; Randomized Evaluation of Sedation Titration for Respiratory Failure Study Investigators. Dexmedetomidine Use in Critically Ill Children With Acute Respiratory Failure. Pediatr Crit Care Med. 2016 Dec;17(12):1131-1141. doi: 10.1097/PCC.0000000000000941.
PMID: 27654816
citation: Tabacco B, Tacconi C, Amigoni A. Survey on monitoring analgesia and sedation in the Italian Pediatric Intensive Care Units. Minerva Anestesiol. 2017 Oct;83(10):1010-1016. doi: 10.23736/S0375-9393.17.11707-4. Epub 2017 Mar 28.
PMID: 28358177
citation: Mason KP, Lerman J. Review article: Dexmedetomidine in children: current knowledge and future applications. Anesth Analg. 2011 Nov;113(5):1129-42. doi: 10.1213/ANE.0b013e31822b8629. Epub 2011 Aug 4.
PMID: 21821507
responsible party type: Principal Investigator
investigator affiliation: Azienda Ospedaliera di Padova
investigator full name: angela amigoni
investigator title: Principal Investigator
mesh term: Dexmedetomidine
sharing ipd: No