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Pain reactivity to non-pharmacological interventions across repeated routine heel sticks inpreterm infants in a neonatal intensive care unit: A pilot study

English title Pain reactivity to non-pharmacological interventions across repeated routine heel sticks inpreterm infants in a neonatal intensive care unit: A pilot study
Applicant Cignacco Müller Eva Lucia
Number 130687
Funding scheme Project funding
Research institution Pflegewissenschaft - Nursing Science (INS) Department Public Health Universität Basel
Institution of higher education University of Basel - BS
Main discipline Paediatrics
Start/End 01.04.2010 - 31.07.2012
Approved amount 116'175.00
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Keywords (6)

pain management; preterm infants; non-pharmacological pain relief; cortisol; pain; pain reduction

Lay Summary (German)

Lead
Lay summary
Dr. Eva Cignacco, Institut für Pflegewissenschaft, Universität BaselLead: Frühgeborene einer neonatalen Intensivstation, erleben viele diagnostische und therapeutische Prozeduren, die mit akuten Schmerzstimuli assoziiert sind. Die Studie geht der Frage nach, welche nicht-medikamentösen schmerzlindernden Massnahmen die Schmerzreaktion dämpfen. Dies insbesondere, wenn das Kind wiederholten Schmerzimpulsen ausgesetzt ist.Hintergrund: Neugeborene, die zu früh zur Welt kommen benötigen für ihr weiteres Gedeihen Intensivpflege. Die Behandlung von Frühgeborenen enthält Massnahmen (z.B. die Blutentnahme), die für das Kind mit Schmerzen verbunden sind. Es ist bekannt, dass Frühgeborene vielen Schmerzimpulsen ausgesetzt sind. Diese Erfahrungen lösen Stress aus und können bereits in den ersten Lebenstagen zu einer Veränderung der Schmerzreaktion führen. Erste Erkenntnisse weisen darauf hin, dass wiederholte Schmerzerfahrungen von Frühgeborenen deren motorische und kognitive Entwicklung negativ beeinflusst. Die Anwendung von Schmerzmedikamenten ist limitiert, denn nur wenige Medikamente sind bei Frühgeborenen getestet. Heute wird zunehmend empfohlen, nicht-medikamentöse schmerzlindernde Massnahmen anzuwenden, wie z.B. die Gabe einer Zuckerlösung in den Mund kurz vor einer geplanten schmerzhaften Prozedur. Eine weitere nicht- medikamentöse Intervention ist das "Halten in Froschstellung". Heute besteht ein mangelndes Wissen darüber, ob diese beiden Massnahmen über eine längere Zeit noch wirksam sind. Das Ziel: Die randomisiert-kontrollierte Studie möchte herausfinden, ob diese Interventionen auch über eine Zeitspanne von 14 Tagen noch wirksam sind und das Frühgeborene ausreichend vor Schmerz schützt. Zu diesem Zweck wurden 71 Frühgeborene nach dem Zufallsprinzip in drei Gruppen eingeteilt: 1) Verabreichung von 0,2ml/kg 20% Saccharose, 2) Halten in der "Froschstellung", 3) die Kombination der beiden Massnahmen. Die Schmerzreaktion wurde während fünf routinemässigen Fersenstichen mittels eines standardisierten Schmerzbeobachtungsbogens evaluiert.Bedeutung: Wird eine nicht-medikamentöse Massnahme auch bei wiederholter Schmerzexposition als wirksam beschrieben, so kann der Praxis der neonatalen Intensivpflege die Empfehlung abgegeben werden, die entsprechende Massnahmen konsequent bei jeder schmerzhaften Verrichtung anzuwenden. Diese nicht-medikamentösen Massnahmen sollen möglichen negativen motorischen und kognitiven Entwicklungen, d
Direct link to Lay Summary Last update: 21.02.2013

Responsible applicant and co-applicants

Employees

Publications

Publication
Physiological parameters after non-pharmacological analgesia in preterm infants: A randomized controlled trial
Gerull Roland, Cignacco Eva, Stoffel Lilian, Sellam Gila, Nelle Mathias (2013), Physiological parameters after non-pharmacological analgesia in preterm infants: A randomized controlled trial, in Acta Paediatrica, 102(8), e368-e373.
Oral sucrose and "facilitated tucking" for repeated pain relief in preterms: a randomized controlled trial.
Cignacco Eva L, Sellam Gila, Stoffel Lillian, Gerull Roland, Nelle Mathias, Anand Kanwaljeet J S, Engberg Sandra (2012), Oral sucrose and "facilitated tucking" for repeated pain relief in preterms: a randomized controlled trial., in Pediatrics, 129(2), 299-308.
[Neonatal intensive care: optimizing pain management in newborn infants].
Sellam Gila, Schulz Claudia, Hämmerli Natascha Schütz, Cignacco Eva (2011), [Neonatal intensive care: optimizing pain management in newborn infants]., in Krankenpflege. Soins infirmiers, 104(9), 32-3.
Contextual factors influencing pain response to heelstick procedures in preterm infants: what do we know? A systematic review.
Sellam Gila, Cignacco Eva L, Craig Kenneth D, Engberg Sandra (2011), Contextual factors influencing pain response to heelstick procedures in preterm infants: what do we know? A systematic review., in European journal of pain (London, England), 15(7), e1-15.
Facilitated tucking as a non-pharmacological intervention for neonatal pain relief: is it clinically feasible?
Cignacco E, Axelin A, Stoffel L, Sellam G, Anand Kjs, Engberg S (2010), Facilitated tucking as a non-pharmacological intervention for neonatal pain relief: is it clinically feasible?, in Acta paediatrica (Oslo, Norway : 1992), 99(12), 1763-5.
Variability in pain response to a non-pharmacological intervention across repeated routine pain exposure in preterm infants: a feasibility study
Cignacco E, Denhaerynck K, Nelle M, Buhrer C, Engberg S (2010), Variability in pain response to a non-pharmacological intervention across repeated routine pain exposure in preterm infants: a feasibility study, in ACTA PAEDIATRICA, 98(5), 842-846.

Collaboration

Group / person Country
Types of collaboration
Universitätskinderspital Basel, UKBB Switzerland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Research Infrastructure
Neonatologie, Universitätsspital Zürich Switzerland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Research Infrastructure
- Exchange of personnel
Neonatologie Inselspital Bern Switzerland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
University of Pittsburgh United States of America (North America)
- in-depth/constructive exchanges on approaches, methods or results
- Publication

Scientific events

Active participation

Title Type of contribution Title of article or contribution Date Place Persons involved
3. Länderkonferenz Pflege und Pflegewissenschaft Talk given at a conference Effektivität nicht-pharmakologischer schmerzlindernder Interventionen bei Frühgeborenen einer neonatalen Intensivstation. Invited Key Note hold at the 22.09.2015 Konstanz, Germany Cignacco Müller Eva Lucia;
Deutscher Pflegetag, 2015, Talk given at a conference Die Erfassung von Schmerz und der Einfluss von Kontextfaktoren auf das Schmerzerleben von Neugeborenen 13.03.2015 Berlin, Germany Cignacco Müller Eva Lucia;
5th Perinatalmedizinisches Symposium Talk given at a conference Schmerzen bei Früh- und Neugeborenen. 15.04.2014 Berlin, Germany Cignacco Müller Eva Lucia;
Hebammenfortbildung, Frauenklinik, Medizinische Hochschule Hannover Talk given at a conference Nicht medikamentöse Schmerzlinderung in der Neonatologie 17.04.2013 Hannover, Germany Cignacco Müller Eva Lucia;
International Conference: Caring to Know, Knowing to Care of the Registered Nurse Asscociation of Ontario Talk given at a conference Effectiveness of non-pharmacological pain relieving interventions in preterm infants 06.06.2012 Jerusalem, Israel Cignacco Müller Eva Lucia;
Conference of the European Academy of Paediatric Societies Talk given at a conference Non pharmacological pain relief in preterm infants 24.10.2011 Kopenhagen, Denmark Cignacco Müller Eva Lucia;
International Forum of Pediatric Pain Poster Contextual Factors associated with pain response in preterm infants 20.10.2011 White Point, Canada Cignacco Müller Eva Lucia;


Knowledge transfer events

Active participation

Title Type of contribution Date Place Persons involved
Weiterbildung Team Neonatologie UKBB Basel Talk 23.04.2012 Basel, Switzerland, Switzerland Cignacco Müller Eva Lucia;
Interprofessioneller Fachlunch Universitätsspital Zürich Talk 19.01.2012 Zürich, Switzerland, Switzerland Cignacco Müller Eva Lucia;


Communication with the public

Communication Title Media Place Year
Media relations: radio, television sucrose-better-than-facilitated-tucking-for-heel-stick-pain-in-preemies Doctor's Channel USA International 2013
Media relations: print media, online media Das ist Zucker! Frühchen, die an einem Glukosestäbchen nuckeln, derweil man ihnen Blut abnimmt... German-speaking Switzerland 2012
Media relations: print media, online media Wie lässt sich das Leiden der Kleinsten lindern? 20 Minuten Western Switzerland German-speaking Switzerland 2012

Associated projects

Number Title Start Funding scheme
159573 Validation of the Bernese Pain Scale for Neonates with Consideration for Contextual Factors 01.06.2015 Project funding

Abstract

Background and significance: Switzerland with its approximately 8% of premature births is having one of the highest premature rates in Europe and most of the preterm neonates need neonatal intensive care. Recur-rent neonatal pain and stress occur routinely during neonatal intensive care, particularly among the extremely low birth weight preterm neonates. It has become clear in recent years that the nervous system undergoes extensive development postnatally and there is increasing evidence that repeated exposure to pain, may lead to serious biobehavioral changes during the sensitive developmental phase of the central nervous system and that these changes may underlie long-term learning and behavior difficulties in this patient population. The frequency of exposure to pain and the adequate treatment of that pain are therefore important factors in later motor and cognitive development in preterm infants requiring intensive care. Pain treatment in infants is viewed as inadequate in the context of acute diagnostic and therapeutic procedures in the NICU. Up to 80% of the analgesic used in neonatal intensive care units (NICU) are either “off label used” or “non-licensed used”. Secon-dary to significant side effects, associated with the use of analgesics drugs, health care providers are often reticence to administer these drugs in the NICU. As an alternative approach non-pharmacological interventions for pain prevention and relief are increasingly being recommended for the prevention and treatment of mild and moderate pain in this population. This type of intervention includes methods that involve reducing the sensitivity of the neonates during and after painful procedures, which have been shown to effectively reduce pain from minor procedures in neonates. Although non-pharmacological interventions have been shown to be efficacious when tested during a single painful procedure there is a lack of evidence related to their efficacy after infants have being exposed to a high number of painful procedures and the accompanying chronic stress. To improve the clinical outcomes there is a critical need for accurate and efficient neonatal pain management for this highly vulnerable patient popula-tion. Specific aims: To determine the sample size needed for a larger randomized clinical trial (RCT) designed to compare the sustained impact of three non-pharmacological approaches on the pain reactivity of premature neo-nates in a NICU.Design and methods: This multicenter pilot study will use a randomized three group, repeated measures design. 72 premature infants from 24 0/7 to 32 0/7 weeks of gestation needing neonatal intensive care will be recruited during the first 2 days of life in three University Clinics (Bern, Basel, Zurich). The premature infants will be randomly assigned to one of three intervention groups (1) oral sucrose, (2) facilitated tucking, or (3) oral sucrose plus facilitated tucking. Sucrose is currently the standard of care in NICUs in Switzerland and will serve as the usual care control condition. The infants will be stratified into two gestational groups to examine the impact of gestational age on the effect size estimates. Five heel sticks across 12-14 days will be videotaped and pain will be rated by 4 independent raters, who are blinded to the data collection period. Raters will use the “Bernese Pain Scale for Neonates” to measure pain before, during and after the heel stick procedure. The physiologic data (heart rate and oxygen saturation) needed to complete the Bernese Pain Scale for Neonates will be down loaded from the clinical database for the same time frame as the neonate is videotaped. Near infrared spectroscopy (NIRS) will be performed during the painful procedures in the one site to measure differences in somatosensory cortical activation during heel sticks in infants managed with the three interventions at a baseline and across repeated heel sticks.Expected value of the proposed project: Adequate and efficient pain management is an important factor in later motor and cognitive development in preterm infants requiring intensive care. This pilot data will provide information about the sample size needed for a larger RCT. That study will compare the impact of the mentioned non-pharmacological interventions on pain reactivity across multiple painful procedures. In addition to examin-ing their individual impact, we will evaluate the impact of using them in combination. The larger study will contribute to a better understanding of the efficacy of non-pharmacological pain relieving methods and their efficacy across repeated pain exposures. This pilot study is a collaborative effort of the disciplines of nursing science and neonatal medicine.
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