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EUROpean Pain Audit In Neonates

NCT01694745 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 6489

Last updated 2014-01-23

No results posted yet for this study

Summary

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.

Conditions

  • Pain
  • Analgesia
  • Sedation
  • Intesive Care
  • Intratracheal Ventilation

Sponsors & Collaborators

  • Hôpital Armand Trousseau

    lead OTHER

Principal Investigators

  • Ricardo Carbajal, MD PhD · Armand Trousseau

Eligibility

Max Age
45 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • Austria
  • Belgium
  • Cyprus
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Italy
  • Lithuania
  • Malta
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01694745 on ClinicalTrials.gov