Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
163 participants
OBSERVATIONAL
2016-01-01
2018-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of Dexmedetomidine During Weaning From Analgesia and Sedation in PICU (TIP-15-01)
NCT03645603
The Efficacy and the Safety of Dexmedetomidine Sedation on the Pediatric Intensive Unit(PICU) Patients.
NCT02296073
Dexmedetomidine Versus Propofol for Continuous Sedation in the Intensive Care Unit (ICU)
NCT00479661
Dexmedetomidine Versus Midazolam for Continuous Sedation in the Intensive Care Unit (ICU)
NCT00481312
Dexmedetomidine for Continuous Sedation
NCT00226785
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
dex group
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
Dexmedetomidine
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dexmedetomidine
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* admission to PICU
* sedation with dexmedetomidine lasted more than 24 hours
* written informed consent
Exclusion Criteria
* hypersensitivity to the active substance
* incomplete data regarding outcome measures
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER
Azienda Ospedaliera di Padova
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
angela amigoni
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
angela amigoni, MD
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliera di Padova
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pediatric Intensive Care Unit, Children's Hospital C.Arrigo, Alessandria, Italy
Alessandria, , Italy
Pediatric Intensive Care Unit, ASST John XXIII Pope Hospital, Bergamo, Italy
Bergamo, , Italy
Pediatric Intensive Care Unit, S.Orsola Malpighi Hospital, University of Bologna, Italy
Bologna, , Italy
Pediatric Intensive Care Unit, Children's Hospital V.Buzzi, Milan, Italy
Milan, , Italy
Pediatric and Neonatal Intensive Care Unit, Maggiore della Carità Hospital, Novara, Italy
Novara, , Italy
Terapia Intensiva Pediatrica Azienda Ospedaliera di Padova
Padua, , Italy
Pediatric Intensive Care Unit, Bambino Gesù Children's Hospital, Rome, Italy
Roma, , Italy
Pediatric Intensive Care Unit, A.Gemelli Hospital, Sacro Cuore Catholic University, Rome Italy
Rome, , Italy
Pediatric Intensive Care Unit, Burlo Garofalo Hospital, University of Trieste, Italy
Trieste, , Italy
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
see Group of Study PeNPAD (Italian Research Group on Pediatric Neurological Protection and Drugs)
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
4466/AO/18; AOP1403
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.