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EUROPAIN Survey(EUROpean Pain Audit In Neonates)
European survey of sedation and analgesia practices for newborns admitted to
intensive care unitsVersion 2
Ricardo Carbajal, MD, PhD1, Mats Erikson, RN, PhD2.
1Principal investigator, Trousseau University Hospital, Paris, France2Principal investigator, Örebro University Hospital, Örebro, Sweden
www.europainsurvey.euThis project was supported by the European Community's Seventh Framework Programme under grant agreement no. 223767
Participating countriesCountry National Principal Investigator
Austria Angelika BERGER
Belgium Bart VAN OVERMEIRE
Cyprus Thalia PAPADOURI
Estonia Mari-Liis ILMOJA
Finland Tarja POLKKI
France Ricardo CARBAJAL
Germany Michael SCHROTH
Greece Kosmas SARAFIDIS
Ireland Eleanor MOLLOY
Italy Paola LAGO
Lithuania Daiva MISIUNAITE
Malta Simon ATTARD MONTALTO
Netherlands Sinno SIMONS
Norway Randi Dovland ANDERSEN
Poland Anna DOBRZANSKA
Portugal Cristina MATOS
Spain Alejandro AVILA-ALVAREZ
Sweden Mats ERIKSSON, RN, PhD
UK Elaine BOYLE
Background and rationale
Neonates admitted to intensive care units undergo many painful procedures
Painful procedures include, for many of the ICU neonates, a tracheal intubation and mechanical ventilation
Pain and stress induced by mechanical ventilation and repetitive procedures or painful diseases have led to the use of sedation and analgesia in some centers
The difficulty of pain measurement has probably contributed to a wide variety of neonatal sedation and analgesia practices
Secondary hypothesis: Non ventilated babies are not sedated.
Practices across Europe and USA
Data on sedation and analgesia practices in ventilated neonates are very rare
SOPAIN study (1995) in USA:Factors predicting the use of on-going analgesia and sedation in neonates included: mechanical ventilation, higher gestational age, and male gender
French EPIPPAIN study (2005): the rate of continuous sedation and analgesia varied among centers between 16.7% to 90.9%
To date, there are no data permitting the comparison of neonatal pain management within the European countries
The availability of these data will enable comparison of practices with state-of-the-art knowledge
Main objective and type of study
Main objectiveTo determine the current clinical practices regarding the use of sedative and analgesic drugs for ventilated and non ventilated newborns in different countries in Europe
Type of study Epidemiological observational study The EUROPAIN STUDY will not interfere with routine
practices of participating units No changes in diagnostic, therapeutic or any managing
strategy of patients are imposed All treatments are authorized for included neonates since
this study does not include any intervention
Inclusion criteria
All neonates up to a corrected age of 44 weeks post conception (ventilated AND non ventilated)
Examples: A baby of 40 weeks gestational age can be included up to 28
days (4 weeks) of post natal age A baby of 32 weeks gestational age can be included up to 12
weeks of post natal age
Data collection
Duration of data collection for every infant: 28 days Data collection stops before 28 days if the infant leaves the unit
(discharge, death, transfer to another unit or hospital) Collected Data: demographic data, modes of respiration, continuous
or intermittent sedative, analgesic or neuro-blocking drugs, pain assessment and drug withdrawal practices.
Data will be entered on a secured web-based questionnaire The electronic data collection forms will be completed by the unit
nurse or physician coordinator or the person that they will designate. For each center, the duration of the inclusion period will be one
month The date of the start of inclusion will be communicated by the
Principal investigators and the NPI
Timeline illustrating inclusion period
Timeline illustrating an example of data collection periods for three infants (black bars)No infant is included after the one-month inclusion period but can, once included,generate data for a maximum of four weeks
Week 1
Week 2
Week 3
Week 4
Week 5
Week 6
Week 7
Week 8
START of the inclusion period in the unit
END of the inclusion period in the unit
Data gathering for neonates already included.
No new inclusions in this period
Patient 1, admitted for 16 days
Patient 2, admitted for 6 weeks
Patient 3, admitted for 3 weeks
MAXIMUM DURATION OF DATA GATHERING FOR THESE EXEMPLES: •Patient 1: 16 days •Patient 2: the first 4 weeks (28 days) of admission •Patient 3: not included in the study
One-month inclusion period
Ethical issues
The Protocol has been approved by Local Ethics committees in France and all participating countries
The French Database has been declared to Commission nationale de l’informatique et des libertés (CNIL) that is responsible for ensuring that information technology remains at the service of citizens, and does not jeopardize human identity or breach human rights, privacy or individual or public liberties
No nominal data is sent for the analysis database The study will be registered in “Clinicaltrials”
Coordination of the study
MONITORING PANEL (Paris) Monitors the progress of the study Ensures communication with all the participating units Constituted by 2 persons working full-time during the study period in Paris Under the responsibility of EUROPAIN STUDY principal investigators. Monitors the start of the study in each unit Contacts and exchanges with local coordinators Follows the rate of inclusions and helps with difficulties that may appear
Center (Unit) Coordination Conducted by the local nurse and medical coordinator In contact with the National Principal Investigator (NPI) for issues dealing with
national coordination and with the "Monitoring Panel" for technical or conceptual issues
Country Coordination NPI ensures that the maximum of eligible units of the country participate NPI coordinates with the principal investigators the preparation of participating
units and the study period for recruiting patients
Organization at the unit level
A nurse and physician coordinator as well as a person to double-check (self-audit) a sample (10%) of files will be designated for each unit.
A web site www.europainsurvey.eu has been created to post educational material for the study
The website allows to download all documents necessary for the study
The nurse and physician coordinator inform the unit staff about the study
A poster presenting the study will be distributed to all centers The medical coordinator or a person that he (she) will chose will
enter the data from the patient’s file into the web-based database The physician coordinator will report general statistics of the unit
like number of beds, number of admission, year ventilator-days Every unit will also report existing guidelines on sedation and
analgesia
Expected results and potential implications
This study will show the rate of sedation analgesia in NICUs across Europe
This study will reveal the differences among countries concerning the type of analgesics and sedatives used for neonates admitted to intensive care units
The results of each unit will be sent to Unit coordinators as well as global results of the whole country (benchmarking)
The neonatal network created during this study as well as the dissemination of the EUROPAIN STUDY results will allow the improvement of neonatal pain management in Europe
The availability of these data will enable comparison of practices with state-of-the-art knowledge
Data entry
Data will be entered in a web-based database (Voozanoo tool) available at www.europainsurvey.eu
Electronic forms are available in English and in every participating country language
Data will be entered locally in each center by the medical coordinator or the person that he will choose
The verified databases will be exported to the “Monitoring Panel” in Paris
The exported databases will contain neither last name nor first name of the patients
Records are identified by an automatically generated number
Website: www.europainsurvey.eu
It allows access to: • the electronic form• all useful an updated information
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