Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01694745
Other study ID # EUROPAIN Survey
Secondary ID
Status Completed
Phase N/A
First received September 25, 2012
Last updated January 22, 2014
Start date October 2012
Est. completion date June 2013

Study information

Verified date February 2013
Source Hôpital Armand Trousseau
Contact n/a
Is FDA regulated No
Health authority France: Committee for the Protection of PersonnesFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: The Commission nationale de l’informatique et des libertés
Study type Observational

Clinical Trial 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.


Description:

1.1 Background and rationale The alleviation of pain is a basic and human right regardless of age. Neonates do feel pain and it has been shown that preterm infants are even more vulnerable to pain than older infants. The more vulnerable preterm neonates are precisely those that are more exposed to pain. Neonates admitted to intensive care units, both neonatal intensive care unit (NICU) and pediatric intensive care unit (PICU), undergo dozens or even hundreds of painful procedures during their stay. These painful procedures include, for many of the ICU neonates, a tracheal intubation followed by mechanical ventilation. The pain and stress that are induced by mechanical ventilation as well as by repetitive procedures or painful diseases has led medical staff to use sedation and analgesia in neonates admitted to intensive care units. The subjectivity and difficulty inherent to pain measurement in neonates have probably contributed to a wide variety of neonatal sedation and analgesia practices. To date, these practices have been rarely studied.

Why would sedation and analgesia be necessary? Mechanical ventilation is a potentially painful intervention. Adults often describe mechanical ventilation as a painful and anxiety-provoking experience. The main objectives of sedation and analgesia are: reduction of pain, stress and irritability, promotion of blood pressure stability, promotion of ventilator synchrony and improvement of oxygenation. In the long term, reduced stress, as well as reduced fluctuations in oxygenation and blood pressure is believed to minimize the risks of neurological injury and death. However, the use of sedation and analgesia is only conceivable in the respect of the principle that must accompany all medical actions: first, do no harm.

Pain and stress undergone during the neonatal period can have deleterious short-term and long-term consequences. Some of these consequences have been reduced with adequate analgesic treatment. Current data show the necessity to give adequate sedation and analgesia to ventilated neonates.

Statements promoting the use of sedation and analgesia The increased awareness that neonates feel pain, the ethical obligation to treat this pain with analgesics, the growing body of evidence demonstrating that untreated neonatal pain can lead to altered reactivity to pain that persists throughout infancy and childhood as well as the need for a humane management of neonates have lead to the development of International and National Guidelines promoting the use of analgesics in the neonatal population. These Guidelines state that units that provide neonatal care should develop and implement guidelines concerning neonatal pain. However, the existing literature is still conflicting regarding the use of sedation and analgesia for ventilated neonates. Current data indicate that there is insufficient evidence to recommend the routine use of opioids in mechanically ventilated newborns and that opioids should be used selectively. Sedation and analgesia in non ventilated babies is extremely rare.

Practices across Europe and USA Data on sedation and analgesia practices in ventilated neonates are very rare. In 1995 the SOPAIN study carried out in the United States showed that factors predicting the use of on-going analgesia and sedation in neonates included: mechanical ventilation, higher gestational age, and male gender. In 2005, the French EPIPPAIN study showed that the rate of continuous sedation and analgesia was 69.6% in ventilated neonates with large variations among centers (16.7% to 90.9%). The most frequently used drugs were midazolam and morphine.

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.

Study Hypothesis

The EUROPAIN study is an epidemiological study that is based on the following hypothesis:

- Most newborn ventilated infants receive continuous sedation and analgesia.

- Non ventilated babies are not sedated.

- Morphine, fentanyl and midazolam are the most frequently drugs used in this setting.

- Infrequent use of validated pain assessment tools to monitor sedation and analgesia occurs in ventilated newborn infants.

- Most units have developed written local guidelines for sedation and analgesia in ventilated neonates, but huge variability exists among practitioners in the same unit, across different units in the same country, and across different countries in Europe.

- Development, dissemination, and regular updates of common European standards will improve the care and clinical outcomes of ventilated newborn infants.

1.2 Main objective • To determine the current clinical practices regarding the use of sedative and analgesic drugs for ventilated newborns in different countries in Europe.

1.3 Principal criteria

- The frequency of ventilated neonates receiving sedation and analgesia in different European units

- The medications used for sedation and analgesia in ventilated neonates across Europe.

- The length of use of medications administered for sedation and analgesia in ventilated neonates

- Similarities and differences in sedation and analgesia practices among European countries

1.4 Secondary objectives and criteria

- 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.

- 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.

- To determine the frequency of use of pain assessment tools in ventilated newborn infants and evaluate their impact on pain management practices.

- To determine practices to assess and prevent withdrawal syndromes. Secondary criteria

- Variations across European countries of the proportions of units that have developed and implemented local written guidelines for sedation and analgesia in ventilated neonates

- Identification and description of national guidelines for sedation and analgesia in neonates in all participating countries. Identification of recommended drugs.

1.5 Type of study

• Epidemiological observational study.

1.6 Study plan 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.

The inclusion criteria are:

• All neonates up to a corrected age of 44 weeks post conception. That means, for example, that a baby of 40 weeks gestational age can be included up to 28 days (4 weeks) of post natal age or that a baby of 32 weeks gestational age can be included up to 12 weeks of post natal age.

At the unit level

- No modifications of current managing protocols or strategies are required by the participation in the EUROPAIN STUDY. The unit coordinators will only provide data on local protocols to manage procedural pain and sedation and analgesia in neonates as well as on general statistics of the unit. All treatments are authorized for included neonates since this study does not include any intervention

- A nurse and physician coordinator as well as a data quality manager will be designated for each unit.

At the national level

• The country coordinator will provide data on national guidelines to treat or prevent procedural or continuous pain in neonates.

Data collection

- The duration of data collection for every included infant is 28 days. However, data collection will stop before 28 days if the infant leaves the unit (discharge, death, transfer to another hospital).

- Data will be collected on individual data collection forms. These forms include demographic data, modes of respiration, continuous or intermittent sedative, analgesic or neuro-blocking drugs, pain assessment and drug withdrawal practices.

- Paper patient data collection forms are written in English with a subtitled translation in the country language. The web-based databases display questionnaires in the country language.

- The 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.

- Data will be entered on a secure web-based questionnaire.

1.7 Justification of number of patients Regarding the number of neonates to include in order to show possible differences in sedation and analgesia practices among the participating European countries, we have considered a scenario where differences are small. Thus, we have chosen an effect size (W) of 0.1. We have also assumed that 15 countries will participate. Using NCSS-PASS 2008 software, we have found that a total sample size of 2303 neonates will achieve 90% power to detect an effect size (W) of 0.1 using a 14 degrees (15 centers) of freedom Chi-Square test with a significance level (alpha) of 0.05. Therefore, we aim at including an average of 154 neonates per participating country.

1.8 Main Actions carried out during the study

- In each country, the National Principal Investigators (NPI) will send invitations to join the study to all level 3 neonatal units of the country. The NPI will then communicate the names, emails and telephone numbers of the units that accept to participate to the EUROPAIN STUDY principal investigators

- The NPI is responsible for the coordination of all units in the country and ensures communication with the EUROPAIN STUDY principal investigators

- The NPI will collect demographic data about the participating country.

- A nurse and physician coordinator as well as a data quality manager will be designated for each unit. The nurse and physician coordinator are responsible for informing all the unit staff about the study.

- The EUROPAIN STUDY principal investigators have prepared a specifically designed web-based database to enter data. Data can be entered directly from the patient's file. A paper copy of this database will be distributed to allow centers that prefer to perform a preliminary entry on paper forms before entering data on the web-based database. The medical coordinator or a person that he (she) will choose will enter the data into these specifically designed databases.

- The physician coordinator will report general statistics of the unit such as number of beds, number of admission, year ventilator-days etc to the Europain study principal investigators.

- Every unit will also report existing local guidelines on sedation and analgesia in ventilated infants, including routines for withdrawal and on the use of pain assessment tools.

- MONITORING PANEL. A monitoring panel will be created to monitor the progress of the study. This panel will ensure communication with all the participating units. This monitoring panel will be constituted by two persons working full-time during the study period. They will be stationed in Paris and working under the responsibility of EUROPAIN STUDY principal investigators.


Recruitment information / eligibility

Status Completed
Enrollment 6489
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group N/A to 45 Weeks
Eligibility Inclusion Criteria:

- • All neonates up to a corrected age of 44 weeks post conceptional. That means, for example, that an infant born at 40 weeks gestational age can be included up to 28 days (4 weeks) of post natal age or that a baby of 32 weeks gestational age can be included up to 12 weeks of post natal age.

NOTE: Since this is an observational epidemiological study, all eligible infants of the unit during the study period should be included.

Exclusion Criteria:

- • The only exclusion criteria of this observational study is the participation of the neonate in a research study including a randomization for the use of sedative or analgesic drugs in ventilated neonates.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
Austria Universitäts-klinik für Kinder- und Jugendheilkunde Innsbruck Innsbruck
Austria Landeskran- kenhaus Leoben Leoben
Austria Universitäts-klinik für Kinder und Jugendheilkunde Salzburg Salzburg
Austria Universitäts klinik für Kinder-und Jugenheilkunde Wien? Wien
Belgium Universitaire Ziekenhuis Antwerpen Antwerpen
Belgium Hôpital Erasme ULB, Bruxelles
Belgium Centre Hospitalier Universitaire Tivoli La Louvière
Belgium Centre Hospitalier Régional de la Citadelle Liège
Cyprus Neonatal Intensiv Care Unit,? Arch. Makarios Hospital?? Nicosia
Estonia Department of Anesthesiology and Intensive Care, Tallinn Children`s Hospital Tallinn
Estonia Paediatric Intensive Care Unit, Clinic of Anaesthesiology and Intensive Care, Tartu University Clinics Tartu
Finland Helsinki University Hospital Helsinki
Finland Kuopio University Hospital? Kuopio
Finland Oulu University Hospital? Oulu
Finland Tampere University Hospital? Tampere
Finland Turku University Hospital? Turku
France CHU Amiens Amiens
France CHU Angers Angers
France CH Arras Arras
France CH Côte Basque Bayonne
France CHU Besançon Besançon
France CHU Bordeaux Bordeaux
France CHU de Brest Brest
France CHU Caen Caen
France CH Chambéry Chambéry
France CH Cherbourg Cherbourg
France CHU Clermont Ferrand Clermont Ferrand
France CHU Dijon Dijon
France CH Le Havre Le Havre
France CH Le Mans Le Mans
France CHU Lyon Croix Rousse Lyon
France Hôpital Femme,Mère, enfant Lyon
France Hôpital de la conception - APHM Marseille
France CHU de Montpellier Montpellier
France CHU Nancy Nancy
France CHU Nice Nice
France CHU de Nîmes Nîmes
France CHR Orléans Orléans
France CHU Pau Pau
France CHU Poitiers Poitiers
France CHU Reims Reims
France CHU Rennes Rennes
France CH Rouen Rouen
France CHR Félix Guyon Saint Denis La Réunion
France Ch Saint Etienne Saint-Etienne
France CHRU de Strasbourg Strasbourg
France CHU Toulouse Toulouse
France CHU Tours Tours
France CH Troyes Troyes
France CH Bretagne Atlantique Vannes
Germany Klinik fUr Kinder und Jugendliche Sozialstiftung Bamberg? Bamberg
Germany Klinikum Coburg? Coburg
Germany Department of Paediatric and Adolescent Medicine University Hospital Erlangen? Erlangen
Germany Cnopf'sche Kinderklinik Nuremberg?
Greece "Gaia" Maternity Hospital Athens
Greece "Lito" Maternity Hospital Athens
Greece "Mitera" General Maternity and Pediatric Clinic Athens
Greece "Rea" Maternity Hospital Athens
Greece Alexandras Hospital general Athens
Greece Children's Hospital "Agia Sophia" Athens
Greece Helena Venilezoy Maternit y Hospital Athens
Greece University Hospital of Heraklion Heraklion
Greece University of Ioannina Ioannina
Greece University of Patras Patras
Greece 1st Dept of Neonatalogy, Aristole University of Thessaloniki Thessaloniki
Greece Menn Esy, Hippokratio General Hospital Thessaloniki
Greece 2nd Dept of Neonatalogy, Aristole University of Thessaloniki? Thessaloniki?
Italy Terapia Intensiva Neonatale e Pediatrica ?Verona
Italy TIN Ospedale San Giovanni di Dio ? Agrigento
Italy UO TIN Neonatologia AOU Sant'Orsola Malpighi Bologna
Italy TIN Bolzano Bolzano
Italy UO TIN e Patologia Neonatale Camposampiero?
Italy TIN Como Valduce Como
Italy U.O. di Neonatologia e PatNeo con T.I. - Istituti Ospitalieri Cremona
Italy Ospedale Careggi Firenze
Italy Patologia Neonatale Lodi Lodi
Italy IN Ospedale Macedonio Melloni Milano-AO Fatebenefratellied Oftalmico Milano
Italy TIN Centro IRCSS Ca Granda-Policlinico Osp.Maggiore Mangiagalli LI? Milano
Italy TIN Modena Modena
Italy TIN/Neonatologia- fondazione MBBM- H San Gerardo? Monza
Italy TIN E Patologia Neonatale Dip. di Salute della donna e del bambino- Università di Padova? Padova
Italy UTIN Perugia? Perugia?
Italy UO Neonatologia Santa Chiara Pisa?
Italy TIN A.O.Bianchi-Melacrino-Morelli Reggio Calabria?
Italy Azienda Ospedaliera ASMN, Reggio Emilia Reggio Emilia
Italy NICU Rimini Rimini
Italy TIN Ospedale Pediatrico Bambino Gesù ? Roma
Italy TIN Ospedale San Pietro FBF? Roma
Italy Azienda Ospedaliera Universitaria di Sassari Sassari
Italy Ospedale Maria Vittoria?, Torino Torino
Italy UO Neonatologia e TIN Ospedale Santa Chiara? Trento
Italy UO TIN e Patologia Neonatale Treviso
Italy Patologia Neonatale Ospedale S.M.Misericordia? Udine
Italy U.O.Patologia e Terapia Intensiva Neonatale AOUI Borgo Roma Verona
Italy TIN Ospedale San Bortolo Vicenza
Lithuania Department of Neonatology Lithuanian University of Health Sciences,? Kaunas
Malta Mater Dei Hospital, Triq Dun Karm Msida
Netherlands Academic medical Center Amsterdam - Emma Children's Hospital Amsterdam
Netherlands ErasmusMC - Sophia Childrens Hospital Rotterdam
Netherlands University Hospital Utrecht - Wilhelmina Children's Hospital Utrecht
Netherlands Maxima Medical Center Veldhoven Veldhoven
Netherlands Isala Clinics Zwolle - Amalia Children's Hospital Zwolle
Norway Aalesund Hospital? Ålesund?
Norway Haukeland University Hospital? Bergen
Norway Nordland Hospital? Bodø
Norway Vestre Viken Hospital? Drammen?
Norway Ostfold Hospital? Fredrikstad?
Norway Haugesund Hospital? Haugesund
Norway Sorlandet Hospital? Kristiansand?
Norway Sykehuset Innlandet Lillehammer? Lillehammer?
Norway Akershus University Hospital? Lørenskog?
Norway Oslo University Hospital - Rikshospitalet? Oslo
Norway Oslo University Hospital - Ullevaal? Oslo
Norway Telemark Hospital? Skien?
Norway Stavanger University Hospital? Stavanger
Norway Vestfold Hospita?l Tønsberg
Norway University Hospital of North Norway? Tromsø?
Norway St. Olavs hospital? Trondheim?
Poland Oddzial Noworodkow? Bydgoszcz
Poland Szpital Wojewódzki Koszalin? Koszalin?
Poland Clinical Hospital Ks.Anna Mazowiecka? Warsaw
Poland Department of obstetric and gynecology, medical University of Warsaw? Warsaw
Poland Oddzial Neonatologiczny? Warsaw
Poland Children's Memorial Health Institute Warsaw? Warsaw?
Poland Hospital Orlowskiego Warsaw? Warsaw?
Poland Departement of Neonato- logy Medical University in Wroclaw? Wroclaw?
Portugal Hospitale Divino Espirito Santo Açores
Portugal Hospital San Marcos Braga
Portugal Maternidade Bissaya Barreto Coimbra
Portugal Maternidade Daniel Matos Coimbra
Portugal Hospitale Espirito Santa Evora
Portugal Hospitale Faro Faro
Portugal Hospitale Vila Nova Gaia Gaia
Portugal Hospital Dona Estefânia Lisboa
Portugal Hospital Santa Maria Lisboa
Portugal Hospitale Amadora Sintra Lisboa
Portugal Hospitale Sao Francisco Xavier Lisboa
Portugal Maternity? Dr Alfredo da? Costa? Lisboa
Portugal Hospitale Funchal Madeira
Portugal Hospital San João Porto
Spain Complexo Hospitalario Universitario? de A Coruña? A Coruña?
Spain Hospital Universitario de Álava Álava
Spain Hospital Universitario Principe de Asturias? Alcalá de Henares
Spain Hospital General de Alicante? Alicante?
Spain Hospital Clinic de Barcelona Barcelona
Spain Hospital de la Santa Creu i Sant Pau Barcelona
Spain Hospital Sant Joan de Déu Barcelona
Spain Hospital Vall d´Hebron Barcelona
Spain Hospital Universitario Puerta del Mar Cádiz
Spain Hospital General de Castellón Castellón de la Plana?
Spain Hospital Universitario de Donostia Donostia
Spain Hospital Universitari Josep Trueta Gerona
Spain Hospital Universitario Severo Ochoa Leganés. Madrid
Spain Hospital San Pedro de Logroño Logroño
Spain Hospital Clínico San Carlos (Madrid) Madrid
Spain Hospital General Universitario Gregorio Marañón Madrid
Spain Hospital Infantil Universitario La Paz Madrid
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitario Central de Asturias Oviedo
Spain Complejo Hospitalario de Navarra Pamplona
Spain Complexo Hospitalario de Pontevedra? Pontevedra?
Spain Hospital Universitario de Salamanca Salamanca
Spain Hospital Universitario Marqués de Valdecilla Santander
Spain Complexo Hospitalario Universitario de Santiago Santiago de Compostela
Spain Hospital Virgen Macarena Sevilla
Spain Hospital Virgen de la Salud (Toledo) Toledo
Spain Hospital Universitari i Politecnic La Fe Valencia
Spain Complexo Hospitalario Universitario de Vigo? Vigo?
Spain Hospital Clínico Lozano Blesa Zaragoza
Spain Hospital Universitario Miguel Servet Zaragoza
Sweden Hospital Lasarettet? Falun
Sweden Universitetssjukhuset? Lund
Sweden Universitetssjukhuset? Örebro?
Sweden Karolinska University Hospital? (Stockholm) Stockholm
Sweden Sachsska Barnsjukhuset? (Stockholm) Stockholm
Sweden Akademiska Barnsjukhuset? Uppsala
United Kingdom Aberdeen Maternity Hospital? Aberdeen
United Kingdom Royal United Hospital Bath?
United Kingdom Royal Berkshire NHSFT? Berkshire
United Kingdom Birmingham Children's Hospital Birmingham
United Kingdom Birmingham Heartlands Hospital? Birmingham
United Kingdom Birmingham Womens Hospital Birmingham
United Kingdom Sandwell and West Birmingham? Birmingham?
United Kingdom Blackpool Teaching Hospital Foundation Trust? Blackpool
United Kingdom Royal Bolton Hospital? Bolton
United Kingdom Bradford Royal Infirmary? Bradford
United Kingdom Royal Alexander Children's Hospital Brighton
United Kingdom Bristol Royal Infirmary? Bristol
United Kingdom St Michael's Hospital, Bristol NICU? Bristol
United Kingdom Southmead Hospital Bristol?
United Kingdom Royal Brompton Hospital? Brompton
United Kingdom Burnley General Hospital? Burnley
United Kingdom Countess of Chester? Chester?
United Kingdom North Tees Hospital? Cleveland
United Kingdom Colchester General Hospital? Colchester
United Kingdom University Hospitals Coventry & Warwick? Coventry
United Kingdom Royal Derby Hospital? Derby
United Kingdom Royal Devon and Exeter NHS Foundation Trust? Devon
United Kingdom Doncaster Royal Infirmary? Doncaster
United Kingdom Edinburgh Royal Infirmary? Edinburgh
United Kingdom Medway Maritime Hospital? Gillingham
United Kingdom Gloucestershire Royal Hospital? Gloucestershire
United Kingdom Royal Gwent Hospital? Gwent
United Kingdom Airedale NHS Foundation Trust? Keighley
United Kingdom Kettering General Hospital? Kettering
United Kingdom Leeds General Infirmary? Leeds
United Kingdom Leicester Royal infirmary NICU? Leicester
United Kingdom Leicester Royal Infirmary PICU? Leicester
United Kingdom Leighton or Mid Cheshire NHS Trust? Leighton
United Kingdom Liverpool Women's Hospital NICU? Liverpool
United Kingdom Evelina Children's Hospital, Guy's and St Thomas' NHS Foundation Trust PICU? London
United Kingdom Great Ormond Street Hospital for Sick Children PICU London
United Kingdom Imperial College London NICU? London
United Kingdom Royal London Hospital? London
United Kingdom Pennine Acute Hospitals NHS Trust? Manchester
United Kingdom St Mary's Hospital Manchester?
United Kingdom King's Mill Hospital, Mansfield? Mansfield?
United Kingdom James Cook University Hospital, Middlesborough? Middlesborough?
United Kingdom West Middlesex University Hospital Middlesex
United Kingdom Newham University Hospital? Newham
United Kingdom Northampton General Hospital Neonatal Unit Northampton
United Kingdom Queen's Medical Centre Nottingham?
United Kingdom Southport & Ormskirk & District General Hospital Neonatal Unit? Ormskirk
United Kingdom John Radcliffe Hospital Oxford?
United Kingdom Derriford Hospital, Plymouth? Plymouth?
United Kingdom Royal Preston Hospital? Preston
United Kingdom Queen's Hospital, Romford? Romford?
United Kingdom Rotherham District General Hospital? Rotherham
United Kingdom Jessop Wing, Sheffield Teaching Hospitals NHS Trust? Sheffield
United Kingdom Royal Shrewsbury Hospital? Shrewsbury
United Kingdom Singleton Hospital Singleton
United Kingdom University Hospital Of North Staffordshire NHS Trust? Staffordshire
United Kingdom Great Western Hospitals NHS Foundation Trust? Swindon
United Kingdom Musgrove Park Hospital, Taunton? Taunton?
United Kingdom Royal Cornwall Hospital Treliske
United Kingdom Warrington Hospital? Warrington
United Kingdom Calderdale Royal Hospital? West Yorkshire
United Kingdom Pinderfields General Hospital? West Yorkshire
United Kingdom New Cross Hospital, Wolverhampton? Wolverhampton
United Kingdom Worcester Royal Hospital? Worcester
United Kingdom University Hospital of South Manchester, Wythenshawe? Wythenshawe?
United Kingdom York Teaching Hospital NHS Foundation Trust? York

Sponsors (1)

Lead Sponsor Collaborator
Hôpital Armand Trousseau

Countries where clinical trial is conducted

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

Outcome

Type Measure Description Time frame Safety issue
Other Variations across European countries of the proportions of units that have developed and implemented local written guidelines for sedation and analgesia in ventilated neonates one year No
Other Identification and description of national guidelines for sedation and analgesia in neonates in all participating countries. Identification of recommended drugs one year No
Primary The frequency of ventilated neonates receiving sedation and analgesia in different European units one year No
Secondary The medications used for sedation and analgesia in ventilated neonates across Europe one year No
Secondary The length of use of medications administered for sedation and analgesia in ventilated neonates one year No
Secondary Similarities and differences in sedation and analgesia practices among European countries one year No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05559255 - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI N/A
Completed NCT04748367 - Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care N/A
Terminated NCT04356352 - Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain Phase 2/Phase 3
Completed NCT05057988 - Virtual Empowered Relief for Chronic Pain N/A
Completed NCT04466111 - Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain
Recruiting NCT05868122 - A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy Phase 3
Recruiting NCT06206252 - Can Medical Cannabis Affect Opioid Use?
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Completed NCT03273114 - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain N/A
Enrolling by invitation NCT06087432 - Is PNF Application Effective on Temporomandibular Dysfunction N/A
Completed NCT05508594 - Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001 Phase 2/Phase 3
Recruiting NCT03646955 - Partial Breast Versus no Irradiation for Women With Early Breast Cancer N/A
Active, not recruiting NCT03472300 - Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
Completed NCT03678168 - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries N/A
Completed NCT03286543 - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System N/A
Completed NCT03931772 - Online Automated Self-Hypnosis Program N/A
Completed NCT02913027 - Can We Improve the Comfort of Pelvic Exams? N/A
Terminated NCT02181387 - Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor? Phase 4
Recruiting NCT06032559 - Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment Phase 3
Active, not recruiting NCT03613155 - Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care

External Links