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 InvestigatorAustria Angelika BERGERBelgium Bart VAN OVERMEIRECyprus Thalia PAPADOURIEstonia Mari-Liis ILMOJAFinland Tarja POLKKIFrance Ricardo CARBAJALGermany Michael SCHROTH Greece Kosmas SARAFIDISIreland Eleanor MOLLOYItaly Paola LAGOLithuania Daiva MISIUNAITEMalta Simon ATTARD MONTALTONetherlands Sinno SIMONSNorway Randi Dovland ANDERSENPoland Anna DOBRZANSKAPortugal Cristina MATOSSpain Alejandro AVILA-ALVAREZSweden Mats ERIKSSON, RN, PhDUK 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 studyMain objective

To 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

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3

Week

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Week

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Week

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Week

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Week

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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 studyMONITORING 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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