EUROpean Pain Audit In Neonates (EUROPAINsurvey)
|ClinicalTrials.gov Identifier: NCT01694745|
Recruitment Status : Completed
First Posted : September 27, 2012
Last Update Posted : January 23, 2014
EUROPAIN Survey is an epidemiological study aimed at assessing current clinical practices regarding the use of sedative and analgesic drugs in newborns admitted to NICUs or PICUs in different countries in Europe. This study is conducted as part of the NeoOpiod study.
The main objective of this study is to determine the current clinical practices regarding the use of sedative and analgesic drugs in newborns in intensive units in different countries in Europe. The principal criteria are: the frequency of ventilated neonates receiving sedation and analgesia, the medications used for sedation and analgesia in ventilated neonates, the length of use of medications administered for sedation and analgesia in ventilated neonates and similarities and differences in sedation and analgesia practices among European countries.
The secondary objectives are: a) to determine the proportion of neonatal units that have developed and implemented local written guidelines to provide continuous sedation and analgesia in ventilated newborn infants as well as to prevent and treat procedural pain, b) to document the published guidelines for neonatal analgesia and sedation in different European countries and develop consensus for common European standards that can be applied in all medical settings, c) to determine the frequency of use of pain assessment tools in ventilated newborn infants and evaluate their impact on pain management practices and d) to determine practices to assess and prevent withdrawal syndromes.
The EUROPAIN STUDY is observational and therefore it will not interfere with routine practices of participating units. No changes in diagnostic, therapeutic or any managing strategy of patients are imposed by the participation in this study. This epidemiological study will only collect data on clinical practices in each unit. It will include all neonates up to a corrected age of 44 weeks post conception.
The maximum duration of data collection for every included infant is 28 days. Data collection will stop before 28 days if the infant leaves the unit (discharge, death, transfer to another hospital). Data will be entered on a secure web-based questionnaire.
|Condition or disease|
|Pain Analgesia Sedation Intesive Care Intratracheal Ventilation|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||6489 participants|
|Official Title:||European Survey of Sedation and Analgesia Practices for Newborns Admitted to Intensive Care Units|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
- The frequency of ventilated neonates receiving sedation and analgesia in different European units [ Time Frame: one year ]
- The medications used for sedation and analgesia in ventilated neonates across Europe [ Time Frame: one year ]
- The length of use of medications administered for sedation and analgesia in ventilated neonates [ Time Frame: one year ]
- Similarities and differences in sedation and analgesia practices among European countries [ Time Frame: one year ]
- Variations across European countries of the proportions of units that have developed and implemented local written guidelines for sedation and analgesia in ventilated neonates [ Time Frame: one year ]
- Identification and description of national guidelines for sedation and analgesia in neonates in all participating countries. Identification of recommended drugs [ Time Frame: one year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01694745
Show 242 Study Locations
|Principal Investigator:||Ricardo Carbajal, MD PhD||Armand Trousseau|