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A bstract Procedural distress is a common occurrence in the NICU and is tied to attempts to support the life and development of vulnerable premature infants. We discuss the epidemiology of procedural distress and the potential negative consequences on infant neurodevelopment. We define procedural distress in the NICU and outline three approaches to limit or to reduce its detrimental effects including minimizing the number of procedures, instituting measures for developmentally supportive care, and using preemptively pharmacologic and nonpharmacologic analgesia. Despite the pervasiveness of procedural distress in the NICU, clinical and administrative measures are available to ameliorate possible harmful outcomes.
Content may be subject to copyright.
12 © 2017 Springer Publishing Company JANUARY/FEBRUARY 2017, VOL. 36, NO. 1
Accepted for publication
August 2016.
Martin Schiavenato, PhD, RN,
is the inventor of a pain detec-
tion device for use in premature
infants. It is not commercial-
ized, but he may at some point
in the future potentially derive
royalties from it.
Liisa Holsti, BSR, PhD,
OT, is the lead inventor of a
medical device which could be
used for managing pain in
preterm infants. In partner-
ship with the Provincial Health
Services Association of British
Columbia, she could, in the
future, receive royalties as a
result of licensing agreements
made with private industry for
commercialization of the device.
To date, she has not received any
Procedural distress is a common occurrence in the NICU and is tied to attempts to support the life and
development of vulnerable premature infants. We discuss the epidemiology of procedural distress and
the potential negative consequences on infant neurodevelopment. We define procedural distress in the
NICU and outline three approaches to limit or to reduce its detrimental effects including minimizing
the number of procedures, instituting measures for developmentally supportive care, and using
preemptively pharmacologic and nonpharmacologic analgesia. Despite the pervasiveness of procedural
distress in the NICU, clinical and administrative measures are available to ameliorate possible harmful
Keywords: pain; premature; infant; prematurity; neurodevelopment; developmental care; NICU;
with conditions that differ vastly from
those of the relative safety of the intrauterine
environment. Procedural distress (PD) has
been defined previously in the pediatric pop-
ulation as the sum of anxiety and pain associ-
ated with invasive interventions surrounding
treatment.1 However, this definition does not
address several nuances related to PD in the
context of premature neonates in the NICU.
Specifically, premature infants experience
a profound neurodevelopmental mismatch
between the plasticity of a rapidly developing
nervous system and the variety of environ-
mental and physical stimuli they encounter
that are required for clinical management
and which can induce significant and often
ongoing stress responses that affect the pre-
mature infant in multiple systems. Our aim
is to define PD in the NICU by highlighting
relevant issues that create the unique condi-
tions that apply to the care of these vulner-
able infants, particularly those born at the
earliest gestational ages.
Each year worldwide, over 15 million
infants are born preterm.2 W ith advances
in health care, even those born at very early
stages of development (75 percent of infants
born at 25 weeks gestation, and .90 percent
born at 27–28 weeks gestation) survive.3
Because infants born extremely preterm
require lifesaving medical diagnostic and
therapeutic procedures, iatrogenic pain in
the NICU is commonplace. In fact, these
infants are exposed routinely to 5–15 painful
procedures per day (e.g., blood tests); cumu-
lative exposure can be as high as 300400
procedures over an admission.4,5
Routine NICU procedures include inser-
tion and removal of various catheters, tra-
cheal intubation, nasal suctioning, punctures
for drawing blood, and so on. Fifty-five pro-
cedures have been identified as “common in
the NICU,” but this count is not exhaus-
tive.6 Cignacco and colleagues7 analyzed
Dening Procedural Distress in the
NICU and What Can Be Done About It
Martin Schiavenato, PhD, RN
Liisa Holsti, BSR, PhD, OT
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VOL. 36, NO. 1, JANUARY/FEBRUARY 2017 13
broadly as being the unseen potential and/or actual damage
to the developing nervous system.
In other words, the dichotomy of skin-breaking versus non–
skin-breaking procedures as a determinant of “pain versus no
pain” is not valid with respect to the consequences they have
on the infant; rather, they are used in an attempt to define a
specific context that can be used for research purposes but
which may be less relevant for clinical management. Indeed,
procedures that may not be considered painful or even invasive
by the clinician may be noxious to the infant. For example,
a seemingly innocuous procedure, such as a diaper change,
induces physiologic and behavioral reactions characteristic of
a painful response19; furthermore, this response is greater in
premature infants than it is in term infants.20 These extended
and heightened responses may occur for several reasons, the
most important of which is that these infants’ central nervous
systems do not distinguish between pain and tactile stimuli
until 35 weeks gestational age.21 Thus, the complex physi-
ologic chain of biochemical and behavioral reactions that can
occur during even the most routine procedures should be
considered to have the potential to induce PD.
Furthermore, philosophically speaking, pain is in the eye
of the beholder. This means that the recognition of “pain” in
these infants who are unable to describe or self-report rests
entirely on its identification or recognition by the clinician or
parent. That is, in premature infants, “distress” (the sum of
anxiety and pain) may be experienced by the patient whether
or not “pain” is observed by the clinician. This problem may
be exacerbated by the disconnect or inconsistency between
the occurrence of routine pain assessments in the NICU and
the incidence of PD.22
Therefore, we define PD in the NICU as iatrogenic stress
induced by care interventions that causes or potentially causes
seen or unseen damage, including altered neurodevelopment.
The PD and its adverse effects may occur whether or not
the procedure is considered invasive or viewed or assessed
as painful by the clinician. In these terms, PD is a frequent
and often silent source of or contributor to pathology for the
preterm infant.
The disparity between ideal circumstances for neurodevel-
opment and the NICU environment is not entirely avoidable.
However, three important avenues are available whereby cli-
nicians can limit, reduce, or avoid PD that can and should be
implemented in the NICU.
1. Decrease or minimize the number of procedures. An
obvious step to reduce PD is a decrease in the number
of procedures or attempts at procedures.5 Mountcastle23
outlines several practical measures to engender a culture
of “minimal pain” in the NICU, including judicious
planning of procedures (i.e., eliminating those deemed
unnecessary whenever possible); using umbilical lines and
27 procedures in the NICU, with clinicians rating 70 percent
of them as painful, whereas Newnham and colleagues8
studied 44 acute procedures in the NICU and found clini-
cians ranked the vast majority as moderately, very, or severely
stressful to infants. The most common painful procedure in
the NICU is heelstick.5 In addition, given the evident rela-
tionship between severity of illness and the need for inter-
ventions, the number of invasive procedures is inversely
correlated with gestational age; that is, more procedures are
performed on infants born of earlier gestation.9 Notably, the
great majority of procedures are considered distressful or
painful by clinicians.
Pain is but one source of stress to the infant whose
otherwise-normal intrauterine development differs signifi-
cantly from life in the NICU. For example, environment-
derived stressors, such as instability in temperature and
humidity, disruption of sleep cycles, various forms of touch,
presence of light and noise, and so on, all have to be pro-
cessed by an infant with ill-equipped, immature sensory
systems.10 This bombardment of sensory input, both envi-
ronmental and procedural, can be damaging to the brain
when experienced during the last trimester of fetal develop-
ment because this period is characterized by rapid growth
and change which leaves the infant particularly vulnerable
to noxious stimuli. A noxious stimulus is one defined as “a
stimulus that is damaging or threatens damage to normal
tiss ues .”11 Although the exact mechanisms by which the
pain experience impacts neurodevelopment in the premature
infant are not yet fully understood,12 a growing body of evi-
dence shows that the repetitive exposure to noxious stimuli
in prematurity is associated with altered brain growth, as well
as negative cognitive, motor, and emotional development.13
Structural brain abnormalities associated with skin-break-
ing procedures include a decrease in white and gray matter
growth as well as reductions of cortical thickness in multiple
regions.14,15 Additional long-term adverse effects of early
pain on health include altered sensitivity to pain, behavioral
problems, learning disorders, vision problems, lower IQ, and
depression, among others.16–18
Common terminology used to characterize PD includes
words such as stress, pain, or distress; thus, some clarification
is required. First, PD is iatrogenic in nature, meaning that it
originates from what we do for these infants in an attempt
to save and sustain their lives. Second, we define PD based
on the stimulus being noxious; that is, based on the inter-
vention’s actual or potential ability to cause tissue damage.
Tissue damage is not limited to that which is visible to the
clinician (e.g., skin-breaking procedures such as heelsticks
and IV starts), but more important, it is also defined more
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14 JANUARY/FEBRUARY 2017, VOL. 36, NO. 1
peripherally inserted central catheters to decrease the need
for peripheral punctures; using specialized formal train-
ing for nurses in the NICU (e.g., nurse residencies); and
evaluating the role of pediatric residents and other novices
in the treatment of NICU patients. Another strategy is
to minimize the number of errors or mishaps associated
with the phlebotomy process. Although we could not
find published data on NICU-specific phlebotomy inci-
dents in blood collection that require additional invasive
blood draws (e.g., clotting of sample, lost samples, insuf-
ficient blood), the issue has been recognized in a general
patient population, and it would be logical to assume that
an evaluation of current processes in the NICU, identifi-
cation of potential sources of errors, and deliberate inter-
ventions to address them may result in a decrease in the
need for additional invasive blood draws.24
Furthermore, both the net number of procedures and
the type of procedure affect distress, with some proce-
dures potentially being less painful than others. For
example, all things being equal, venipuncture is thought
to be less painful than heelstick and a preferred method
for blood collection.25 Finally, the wider use and applica-
tion of new and up-and-coming microsensor platforms
that use minimal or no blood in laboratory diagnostics
should markedly reduce the need for blood volume and
blood collection in the NICU.26,27 Thus, opportunities
to reduce or minimize PD by addressing the process of
blood collection and the number and type of procedures
performed seem plentiful (see Sidebar); however, they
require a concerted effort to assess and address in current
2. Adopt developmental care practices. By developmental
care (DC), we mean a clinical milieu that acknowledges
the premature infant as a vulnerable human out of his
or her normal intrauterine developmental trajectory and
one that fosters and maximizes adaptation and success-
ful growth and development. As a concept, DC in the
NICU has been defined further as promoting parental/
family involvement in the care of the infant beginning
immediately after birth and characterized by multidis-
ciplinary collaboration.28 Gibbins and colleagues,29 in
their universe of developmental care (UDC), highlight
the connection between the infant and the environment,
or more specific to us, the relationship between neuro-
development and PD through a shared boundary, that
is, the skin, which they define from a neurodevelopmen-
tal perspective as the surface of the brain. Importantly,
care providers cannot view the developing brain directly;
nevertheless, clinicians and families can and do interact
routinely within the context of this shared boundary.
Therefore, the cues or responses that are observed in
infants, coupled with the behaviors that we bring to these
interactions, have a potential for positive or negative con-
tribution to infant development.30,31 In other words, even
with the need to perform a painful or distressful proce-
dure, measures are available that caregivers can adopt to
enhance the outcome of the interaction. This group out-
lines the core measures for developmentally supportive
care according to the UDC model, and they specifically
address PD (see Sidebar).32
3. Use analgesia preemptively. DC advocates the use of
preemptive analgesia, but, because of its breadth and
importance, we choose to emphasize it separately here.
The last 10–15 years have seen an about-face in the
appreciation to the need for and importance of provid-
ing analgesia to the premature infant and a growth in
knowledge and options of the benefits and effects of avail-
able interventions. However, questions remain as to the
consistency with which these interventions are applied,
Measures to Decrease or Minimize
the Number of Distress-Inducing
Procedures in the NICU
• Judiciouslypla nprocedures; elimin ateproceduresif possible.
• Whenava ilable,useopt ionsthata relesspa inful than
heelsticks (e.g., peripheral lines, umbilical catheters).
• Increase clinicia nexpert isewith procedures,reduce
procedures by novices, and use formal specialized training.
• Asse sscurrent laboratorypract icesandinter venetoreduce
occurrence of mishaps that require additional blood draws
(e.g., clotting of sample, lost samples, insufficient blood).
• Considera ndapplytechnologica lsolutionst hatmightus e
minimal or no blood in laboratory diagnostics.
Developmentally Supportive Measures
for Procedural Distress in the NICU
• Takeamult idisciplina ryapproacha ndinvolve/con sulta
broad range of clinicians as needed.
• Asse ssinfa ntsforpai nordist ressduri ngallpro ceduresand
caregiving activities.
• Useava lid,stand ardizedpa inasse ssmenttoolanddoc ument
a pain score.
• Involveand informpa rentsofthepa in/distress management
plan of care for their infant(s).
• Encouragepa rents/familyto providecomfortto theinf ant.
Adapted from Coughlin, Gibbins, and Hoath.32
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TABLE 2 n  Survey of Pharmacologic Approaches to Minimize Procedural Distress in the NICU
Drug Comments Referencesa
Local and topical anesthetics Lidocaine infiltration is commonly used to relieve pain from
Eutectic mixture of local anesthetic (EMLA) cream is used for
procedures such as venipuncture and lumbar puncture;
however, it is not effective for heelsticks.
Committee on Fetus and Newborn and Section
on Anesthesiology and Pain Medicine.37
Hall and Anand.41
Opioids Morphine is commonly used as a continuous infusion in
postoperative or ventilated infants or intermittently for
acute pain/invasive procedures. Morphine side effects are
significant, and its effectiveness, benefits, and long-term effects
on neurodevelopment are controversial and remain under
Fentanyl is 50 –100 times more potent than morphine; it is not
recommended for routine use in mechanically ventilated
infants. Remifentanil, a short-acting fentanyl derivative, may be
an alternative for short-term procedures, but further studies are
needed to examine its long-term effects.
Benzodiazepines These are anxiolytics that provide sedation and muscle relaxation,
but it is impor tant to keep in mind that they have little or no
analgesic effects; they include midazolam and lorazepam.
Alternative medications Other agents such as propofol, ketamine, and dexmedetomidine
have been proposed; however, they should be used with
caution because of the lack of studies establishing their safety,
efficacy, and dosing.
Acetaminophen in oral, rectal, and intravenous formulations
has been used in preterm, it may help decrease the need for
morphine. However, more data are needed to establish safety,
efficacy, and dosing.
Nonsteroidal anti-inflammatory drugs (NSAIDs) are potentially
useful to treat preterm procedural distress; however, these
drugs are generally used in closure of patent ductus ar teriosus,
and little data exist on their analgesic effects.
aConsult a current NICU drug guide for proper dosage, side effects, and other important considerations.
and significant concerns remain regarding the long-term
effects of some.33 –36 Analgesic interventions can be classi-
fied as pharmacologic and nonpharmacologic. Table 1 lists
a survey of several tools or approaches available to allevi-
ate or prevent PD that are not drug based. In general,
much has been published about the use, effectiveness,
and other clinical factors associated with these inter-
ventions which are outside the scope of this work; see
“References” column in Table 1. Similarly, Table 2 lists a
survey of common pharmacologic interventions, and the
reader is urged to consult the “References” section for
clinical details and specific application.
TABLE 1 n  Survey of Nonpharmacologic Approaches to Minimize Procedural Distress in the NICU
Intervention Comments References
Sweet solutions Recent AAP guidelines recommend further study is
needed on dose and on long-term effect s of sweet
solutions administered repeatedly.
Committee on Fetus and Newborn and Section on
Anesthesiology and Pain Medicine.37
Stevens and colleagues.38
Johnston and colleagues.39
Pillai Riddell and colleagues.40
Nonnutritive sucking For preterm infants, nonnutritive sucking is usually
combined with other nonpharmacologic treatments
for additive effects.
Facilitated tucking Facilitated tucking is a holding strategy whereby a
nurse or other caregiver provides gentle but firm
containment of an infant’s limbs before, during, and
after a painful procedure. Facilitated tucking along
with a soother is the strategy used in many NICUs
Skin-to-skin holding/rocking Skin-to-skin holding or kangaroo care is a method
whereby a parent holds an infant on his or her chest
with direct skin-to-skin contact.
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16 JANUARY/FEBRUARY 2017, VOL. 36, NO. 1
The care of the premature infant often requires lifesaving
and life-sustaining interventions. Paradoxically, these proce-
dures carry a negative toll in this burgeoning and vulnerable
critical period of infant neurodevelopment. We define PD
in the NICU as care interventions that cause or potentially
cause physiologic damage (obvious or not) with short- and/
or long-term consequences, including altered neurodevelop-
ment and its associated sequelae. Procedural distress may or
may not be construed or assessed as “pain” by the clinician;
instead, PD is defined by the noxious effect of the stimulus
or procedure on the infant. As such, PD is pervasive, and
mounting evidence points to it as a significant contributor
to the negative outcomes of prematurity. However, clinicians
can intervene and mitigate the effects of PD. Options for
this include the preemptive use of analgesia through phar-
macologic or nonpharmacologic means, the focused delivery
of DC interventions to promote adaptation to the extrauter-
ine environment and effective growth and development, and
deliberate administrative and clinical efforts to decrease the
number of procedures needed. Procedures in the NICU are a
necessity; however, their noxious effects can be minimized or
eliminated with a combination of considered and purposeful
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About the Authors
Martin Schiavenato, PhD, RN, is a former NICU nurse and a
pediatric pain researcher. His research interests are at the intersection of
technology and the care of vulnerable infants. He is an associate profes-
sor at the College of Nursing, Washington State University.
Liisa Holsti, BSR, PhD, OT, worked clinically in the NICU and
in the Neonatal Follow-up Program as an occupational therapist for
almost 20 years. She now holds a Canada Research Chair in Neonatal
Health and Development and is an associate professor in Occupational
Science and Occupational Therapy at UBC and a scientist at the Child
and Family Research Institute. Her program of research focuses on
developing novel ways to support optimal development in these extremely
high-risk infants.
For further information, please contact:
Martin Schiavenato, PhD, RN
WSU College of Nursing
P.O. Box 1495
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NN36-1_Final_A3_012-017.indd 17 12/22/16 8:09 AM
... Estas concepciones erróneas motivaron un insuficiente tratamiento del dolor en esta etapa de la vida, con las consiguientes consecuencias sobre la salud física y psíquica. (1,2) Actualmente se sabe que existen receptores y vías de transmisión y procesamiento del dolor desde el período fetal. En el recién nacido a término y pretérmino están inmaduros aún muchos mecanismos inhibitorios, por lo que estos pueden presentar, incluso, respuestas fisiológicas y hormonales exageradas frente a un mismo estímulo doloroso, con respecto a las mostradas por niños de mayor edad o adultos, además de presentar menor umbral para el dolor a medida que la edad gestacional del paciente es menor. ...
... (1) En el recién nacido prematuro, debido a la inmadurez de su desarrollo neurológico, el dolor, sobre todo cuando es prolongado, se ha asociado a trastornos a largo plazo, como alteraciones en el crecimiento cerebral, trastornos del desarrollo cognitivo, motor y emocional; además de alteraciones en la sensibilidad al dolor, problemas de conducta y de la visión, entre otros. (2) Las respuestas que se producen frente a un estímulo doloroso han permitido, a su vez, establecer diversas escalas, de las que han sido publicadas y validadas más de 50, pero que tienen pobre empleo en la práctica clínica. (3,4,5) Una de las más utilizadas ha sido la escala Revista Cubana de Pediatría. ...
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Introduction: Pain management is a priority in Neonatal Intensive Care Units. There are not antecedents in Cuba of any protocol carried out for management of neonatal pain, apart from the pharmacological treatment during neonatal respiratory assistance or surgery. Objective: To determine effectiveness of a protocol for prevention and pain relief in infants with less than 1500 grams, mainly based on recommendations of the Ibero-American Society of Neonatology. Methods: A prospective analytical study of before and after was made in 55 infants with less than 1500 grams, who were born in the Teaching Gynecological and Obstetric Provincial Hospital of Matanzas, Cuba, in the period from March,2016 to March, 2018. For the study, the intensity of pain was compared by means of the COMFORTneo scale, which was carried out during the performance of three procedures: umbilical vein catheterization, percutaneous venous catheterization and heel lance; in two patients groups: one before (n=29) and the other after the implementation of the pain protocol (n=26). Spearman coefficient was used for statistical analysis of ordinal qualitative variables. All p< 0.05 values were considered significant. Results: The average weight of the studied newborns was 1 180 grams. After implementing the protocol, a significant decrease in pain intensity was observed during the performance of the selected procedures. Non-pharmacological measures were the most used. Conclusion: The implemented protocol is effective for decrease pain intensity in newborns with less than 1 500 grams.
... Estas concepciones erróneas motivaron un insuficiente tratamiento del dolor en esta etapa de la vida, con las consiguientes consecuencias sobre la salud física y psíquica. (1,2) Actualmente se sabe que existen receptores y vías de transmisión y procesamiento del dolor desde el período fetal. En el recién nacido a término y pretérmino están inmaduros aún muchos mecanismos inhibitorios, por lo que estos pueden presentar, incluso, respuestas fisiológicas y hormonales exageradas frente a un mismo estímulo doloroso, con respecto a las mostradas por niños de mayor edad o adultos, además de presentar menor umbral para el dolor a medida que la edad gestacional del paciente es menor. ...
... (1) En el recién nacido prematuro, debido a la inmadurez de su desarrollo neurológico, el dolor, sobre todo cuando es prolongado, se ha asociado a trastornos a largo plazo, como alteraciones en el crecimiento cerebral, trastornos del desarrollo cognitivo, motor y emocional; además de alteraciones en la sensibilidad al dolor, problemas de conducta y de la visión, entre otros. (2) Las respuestas que se producen frente a un estímulo doloroso han permitido, a su vez, establecer diversas escalas, de las que han sido publicadas y validadas más de 50, pero que tienen pobre empleo en la práctica clínica. (3,4,5) Una de las más utilizadas ha sido la escala Revista Cubana de Pediatría. ...
Full-text available
Resumen Introducción: La atención al dolor resulta prioritaria en las unidades de cuidados intensivos neonatales. No se recogen antecedentes en Cuba de implementación de algún protocolo para el abordaje del dolor en neonatos, que no se limite solamente al tratamiento farmacológico durante la asistencia respiratoria o cirugía neonatal. Objetivo: Determinar la efectividad de un protocolo para la prevención y alivio del dolor en recién nacidos <1500 gramos, basado principalmente en las recomendaciones de la Sociedad Iberoamericana de Neonatología. Métodos: Estudio basado en las recomendaciones de la Sociedad Iberoamericana de Neonatología, de tipo analítico prospectivo de ANTES y DESPUÉS en 55 neonatos <1500 gramos, nacidos en el Hospital Ginecoobstétrico Docente Provincial de Matanzas en el período marzo/2016 a marzo/2018, en el cual se comparó la intensidad del dolor según la escala COMFORTneo aplicada durante la realización de tres procederes: inserción del catéter venoso umbilical, inserción de catéter percutáneo y punción del talón, en dos grupos de pacientes: un grupo antes (n=29) y un grupo después de aplicar el protocolo de dolor (n=26). Para el análisis de variables se empleó el coeficiente de Spearman. Se consideró significativo todo valor p<0,05. Resultados: El peso promedio de los neonatos estudiados fue 1 180 gramos. Luego de la implementación del protocolo se observó una disminución significativa en la intensidad del dolor durante la realización de los procederes seleccionados. Las medidas no farmacológicas fueron las más empleadas. Conclusiones: El protocolo implementado es efectivo para lograr disminuir la intensidad del dolor en neonatos <1 500 gramos.
... Infants in intensive care units may need ventilators and are frequently subjected to invasive and painful processes such as endotracheal suctioning. [4][5][6] Suction is performed frequently to eliminate excessive secretions and reduce possible airway obstruction, and although necessary, it is a harmful stimulant. Pain-induced behavioral and physiological changes have been observed in infants during suctioning. ...
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Background: Endotracheal suctioning, despite its necessity, is one of the procedures that can cause pain and stress for infants admitted to neonatal intensive care units. Pain and stress manifest with physiological and behavioral responses in infants. Purpose: This study is a cross-sectional clinical trial that aimed to investigate the effect of endotracheal suctioning using four-handed care on the physiological criteria and behavioral responses of preterm infants. Methods:In this study, 40 infants were randomly divided into two groups of 20, one group was first suctioned by the routine method (two hands) and then with the four-handed method. The other group was first suctioned by the four-handed method and then with the routine one. The ALPS NEO was used to evaluate behavioral criteria. One camera recorded facial expressions and body movements, and physiological data were recorded from the monitor simultaneously. Results:Four-handed suctioning method can prevent an increase in heart rate during and two minutes after suctioning but it did not affect behavioral responses and oxygen saturation of the preterm infants admitted to NICUs. Since one of the symptoms of pain and stress in infants is the change of vital signs, especially the heart rate, stable heart rate during painful procedures can be an indication of the effectiveness of the four-hand method in invasive procedures such as suctioning. Implications for Practice: We recommend four-handed method for suctioning of endotracheal tube. Implications for Research: Evaluate the effect of four-handed care by mother on physiological criteria and behavioral responses of the preterm infants.
Background: Of all preterm births, approximately 82% are moderate to late preterm. Moderate to late preterm infants are often treated like full-term infants despite their physiological and metabolic immaturity, increasing their risk for mortality and morbidity. Purpose: To describe the relationship between routine caregiving methods and physiological markers of stress and hypoxemia in infants born between 32 and 36 weeks' gestation. Methods: This descriptive study used a prospective observational design to examine the relationship between routine caregiving patterns (single procedure vs clustered care) and physiological markers of stress and hypoxemia such as regional oxygen saturation, quantified as renal and cerebral regional oxygen saturation (StO2), systemic oxygen saturation (Spo2), and heart rate (HR) in moderate to late preterm infants. Renal and cerebral StO2 was measured using near-infrared spectroscopy during a 6-hour study period. Spo2 and HR were measured using pulse oximetry. Results: A total of 231 procedures were captured in 37 participants. We found greater alterations in cerebral StO2, renal StO2, Spo2, and HR when routine procedures were performed consecutively in clusters than when procedures were performed singly or separately. Implications for practice and research: Our results suggest that the oxygen saturation and HR of moderate to late preterm infants were significantly altered when exposed to routine procedures that were performed consecutively, in clusters, compared with when exposed to procedures that were performed singly or separately. Adequately powered randomized controlled trials are needed to determine the type of caregiving patterns that will optimize the health outcomes of this vulnerable population.
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As a standard of care for preterm/term newborns effective pain management may improve their clinical and neurodevelopmental outcomes. Neonatal pain is assessed using context-specific, validated, and objective pain methods, despite the limitations of currently available tools. Therapeutic approaches reducing invasive procedures and using pharmacologic, behavioral, or environmental measures are used to manage neonatal pain. Nonpharmacologic approaches like kangaroo care, facilitated tucking, non-nutritive sucking, sucrose, and others can be used for procedural pain or adjunctive therapy. Local/topical anesthetics, opioids, NSAIDs/acetaminophen and other sedative/anesthetic agents can be incorporated into NICU protocols for managing moderate/severe pain or distress in all newborns. Copyright © 2014 Elsevier Inc. All rights reserved.
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Medical management of newborn infants often necessitates recurrent painful procedures, which may alter nociceptive pathways during a critical developmental period and adversely effect neuropsychological outcomes. To mitigate the effects of repeated painful stimuli, opioid administration for peri-procedural analgesia and ICU (intensive care unit) sedation is common in the NICU (neonatal intensive care unit). A growing body of basic and animal evidence suggests potential long-term harm associated with neonatal opioid therapy. Morphine increases apoptosis in human microglial cells, and animal studies demonstrate long-term changes in behavior, brain function, and spatial recognition memory following morphine exposure. This comprehensive review examines existing preclinical and clinical evidence on the long-term impacts of neonatal pain and opioid therapy.
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SUMMARY Infants born preterm (<37 weeks of gestation) are particularly vulnerable to procedural stress and pain exposure during neonatal intensive care, at a time of rapid and complex brain development. Concerns regarding effects of neonatal pain on brain development have long been expressed. However, empirical evidence of adverse associations is relatively recent. Thus, many questions remain to be answered. This review discusses the short- and long-term effects of pain-related stress and associated treatments on brain maturation and neurodevelopmental outcomes in children born preterm. The current state of the evidence is presented and future research directions are proposed.
Background: Despite evidence of the long-term implications of unrelieved pain during infancy, it is evident that infant pain is still under-managed and unmanaged. Inadequately managed pain in infancy, a period of exponential development, can have implications across the lifespan. Therefore, a comprehensive and systematic review of pain management strategies is integral to appropriate infant pain management. This is an update of a previously published review update in the Cochrane Database of Systematic Reviews (2015, Issue 12) of the same title. Objectives: To assess the efficacy and adverse events of non-pharmacological interventions for infant and child (aged up to three years) acute pain, excluding kangaroo care, sucrose, breastfeeding/breast milk, and music. Search methods: For this update, we searched CENTRAL, MEDLINE-Ovid platform, EMBASE-OVID platform, PsycINFO-OVID platform, CINAHL-EBSCO platform and trial registration websites (; International Clinical Trials Registry Platform) (March 2015 to October 2020). An update search was completed in July 2022, but studies identified at this point were added to 'Awaiting classification' for a future update. We also searched reference lists and contacted researchers via electronic list-serves. We incorporated 76 new studies into the review. SELECTION CRITERIA: Participants included infants from birth to three years in randomised controlled trials (RCTs) or cross-over RCTs that had a no-treatment control comparison. Studies were eligible for inclusion in the analysis if they compared a non-pharmacological pain management strategy to a no-treatment control group (15 different strategies). In addition, we also analysed studies when the unique effect of adding a non-pharmacological pain management strategy onto another pain management strategy could be assessed (i.e. additive effects on a sweet solution, non-nutritive sucking, or swaddling) (three strategies). The eligible control groups for these additive studies were sweet solution only, non-nutritive sucking only, or swaddling only, respectively. Finally, we qualitatively described six interventions that met the eligibility criteria for inclusion in the review, but not in the analysis. DATA COLLECTION AND ANALYSIS: The outcomes assessed in the review were pain response (reactivity and regulation) and adverse events. The level of certainty in the evidence and risk of bias were based on the Cochrane risk of bias tool and the GRADE approach. We analysed the standardised mean difference (SMD) using the generic inverse variance method to determine effect sizes. MAIN RESULTS: We included total of 138 studies (11,058 participants), which includes an additional 76 new studies for this update. Of these 138 studies, we analysed 115 (9048 participants) and described 23 (2010 participants) qualitatively. We described qualitatively studies that could not be meta-analysed due to being the only studies in their category or statistical reporting issues. We report the results of the 138 included studies here. An SMD effect size of 0.2 represents a small effect, 0.5 a moderate effect, and 0.8 a large effect. The thresholds for the I2 interpretation were established as follows: not important (0% to 40%); moderate heterogeneity (30% to 60%); substantial heterogeneity (50% to 90%); considerable heterogeneity (75% to 100%). The most commonly studied acute procedures were heel sticks (63 studies) and needlestick procedures for the purposes of vaccines/vitamins (35 studies). We judged most studies to have high risk of bias (103 out of 138), with the most common methodological concerns relating to blinding of personnel and outcome assessors. Pain responses were examined during two separate pain phases: pain reactivity (within the first 30 seconds after the acutely painful stimulus) and immediate pain regulation (after the first 30 seconds following the acutely painful stimulus). We report below the strategies with the strongest evidence base for each age group. In preterm born neonates, non-nutritive sucking may reduce pain reactivity (SMD -0.57, 95% confidence interval (CI) -1.03 to -0.11, moderate effect; I2 = 93%, considerable heterogeneity) and improve immediate pain regulation (SMD -0.61, 95% CI -0.95 to -0.27, moderate effect; I2 = 81%, considerable heterogeneity), based on very low-certainty evidence. Facilitated tucking may also reduce pain reactivity (SMD -1.01, 95% CI -1.44 to -0.58, large effect; I2 = 93%, considerable heterogeneity) and improve immediate pain regulation (SMD -0.59, 95% CI -0.92 to -0.26, moderate effect; I2 = 87%, considerable heterogeneity); however, this is also based on very low-certainty evidence. While swaddling likely does not reduce pain reactivity in preterm neonates (SMD -0.60, 95% CI -1.23 to 0.04, no effect; I2 = 91%, considerable heterogeneity), it has been shown to possibly improve immediate pain regulation (SMD -1.21, 95% CI -2.05 to -0.38, large effect; I2 = 89%, considerable heterogeneity), based on very low-certainty evidence. In full-term born neonates, non-nutritive sucking may reduce pain reactivity (SMD -1.13, 95% CI -1.57 to -0.68, large effect; I2 = 82%, considerable heterogeneity) and improve immediate pain regulation (SMD -1.49, 95% CI -2.20 to -0.78, large effect; I2 = 92%, considerable heterogeneity), based on very low-certainty evidence. In full-term born older infants, structured parent involvement was the intervention most studied. Results showed that this intervention has little to no effect in reducing pain reactivity (SMD -0.18, 95% CI -0.40 to 0.03, no effect; I2 = 46%, moderate heterogeneity) or improving immediate pain regulation (SMD -0.09, 95% CI -0.40 to 0.21, no effect; I2 = 74%, substantial heterogeneity), based on low- to moderate-certainty evidence. Of these five interventions most studied, only two studies observed adverse events, specifically vomiting (one preterm neonate) and desaturation (one full-term neonate hospitalised in the NICU) following the non-nutritive sucking intervention. The presence of considerable heterogeneity limited our confidence in the findings for certain analyses, as did the preponderance of evidence of very low to low certainty based on GRADE judgements. Authors' conclusions: Overall, non-nutritive sucking, facilitated tucking, and swaddling may reduce pain behaviours in preterm born neonates. Non-nutritive sucking may also reduce pain behaviours in full-term neonates. No interventions based on a substantial body of evidence showed promise in reducing pain behaviours in older infants. Most analyses were based on very low- or low-certainty grades of evidence and none were based on high-certainty evidence. Therefore, the lack of confidence in the evidence would require further research before we could draw a definitive conclusion.
Background: Neonates cared for in neonatal intensive care units are exposed to many painful and stressful procedures that, cumulatively, could impact later neurodevelopmental outcomes. However, a systematic analysis of these effects is yet to be reported. Objectives: The aim of this research was to review empirical studies examining the association between early neonatal pain experiences of preterm infants and the subsequent developmental outcomes of these children across different ages. Methods: The literature search was performed using the PubMed, PsycINFO, Lilacs, and SciELO databases and included the following key words: "pain," "preterm," and "development." In addition, a complementary search was performed in online journals that published pain and developmental studies to ensure all of the target studies had been found. The data were extracted according to predefined inclusion and exclusion criteria. Results: Thirteen studies were analyzed. In infants born extremely preterm (gestational age ≤29 wk) greater numbers of painful procedures were associated with delayed postnatal growth, with poor early neurodevelopment, high cortical activation, and with altered brain development. In toddlers born very preterm (gestational age ≤32 wk) biobehavioral pain reactivity-recovery scores were associated with negative affectivity temperament. Furthermore, greater numbers of neonatal painful experiences were associated with a poor quality of cognitive and motor development at 1 year of age and changes in cortical rhythmicity and cortical thickness in children at 7 years of age. Conclusions: For infants born preterm, neonatal pain-related stress was associated with alterations in both early and in later developmental outcomes. Few longitudinal studies examined the impact of neonatal pain in the long-term development of children born preterm.
In the USA, inpatient phlebotomy services are under constant operational pressure to optimise workflow, improve timeliness of blood draws, and decrease error in the context of increasing patient volume and complexity of work. To date, the principles of Lean continuous process improvement have been rarely applied to inpatient phlebotomy. To optimise supply replenishment and cart standardisation, communication and workload management, blood draw process standardisation, and rounding schedules and assignments using Lean principles in inpatient phlebotomy services. We conducted four Lean process improvement events and implemented a number of interventions in inpatient phlebotomy over a 9-month period. We then assessed their impact using three primary metrics: (1) percentage of phlebotomists drawing their first patient by 05:30 for 05:00 rounds, (2) percentage of phlebotomists completing 08:00 rounds by 09:30, and (3) number of errors per 1000 draws. We saw marked increases in the percentage of phlebotomists drawing their first patient by 05:30, and the percentage of phlebotomists completing rounds by 09:30 postprocess improvement. A decrease in the number of errors per 1000 draws was also observed. This study illustrates how continuous process improvement through Lean can optimise workflow, improve timeliness, and decrease error in inpatient phlebotomy. We believe this manuscript adds to the field of clinical pathology as it can be used as a guide for other laboratories with similar goals of optimising workflow, improving timeliness, and decreasing error, providing examples of interventions and metrics that can be tailored to specific laboratories with particular services and resources.
Objective: To examine the association of pain assessment scores achieved through regular reassessment practice, as required by the Joint Commission (JC), with painful events and the use of analgesics in premature, ventilated infants. Study design: A cross-sectional study was performed in two tertiary level neonatal intensive care units. Pain was assessed at regular intervals at each center using validated multidimensional instruments in accordance with the JC standards. Result: Sample comprised 196 ventilated premature infant patient-days. Overall, 2% of scores suggested the presence of pain, and 0.1% of pain scores were associated with analgesia. Ventilated infants who were exposed to multiple pain-associated procedures in a day never demonstrated pain score elevations despite infrequent preemptive or continuous analgesic administration. Conclusion: Pain assessment scores achieved using regular reassessment processes were poorly correlated with exposure to pain-associated procedures or conditions. Low pain scores achieved through regular reassessment may not correlate to low pain exposure. Resources that are expended on regular reassessment processes may need to be reconsidered in light of the low yield for clinical alterations in care in this setting.