BACKGROUND:Strong evidence suggests that maternal-infant skin-to-skin contact (SSC) is effective in reducing behavioural responses to pain. Given the multi-sensory benefits of SSC, it is highly likely that SSC provided during pain in early life may reduce pain-induced brain activity. The aim of this study is to examine the effect of SSC compared to 24% sucrose on pain-induced activity in the preterm infant brain during a medically required heel lance. Secondary objectives include determining (a) differences between behavioural pain response and noxious-related brain activity during heel lance and (b) rate of adverse events across groups. METHODS:We will randomly assign 126 babies (32 to 36 completed weeks gestational age) admitted to the neonatal intensive care unit, and their mothers within the first seven days of age to receive (i) SSC plus sterile water and (ii) 24% oral sucrose. Each baby will receive a medically indicated heel lance, following a no treatment baseline period. The primary outcome is noxious-related brain activity measured using an electroencephalogram (EEG) pain-specific event-related potential. Secondary outcomes include pain intensity measured using a bio-behavioural infant pain assessment tool (Premature Infant Pain Profile-Revised) and rate of adverse events. DISCUSSION:This will be the first clinical trial to compare the effect of SSC and 24% sucrose on pain-induced brain activity in the preterm infant brain during a clinical noxious stimulus, measured using EEG. Given the negative neurodevelopmental outcomes associated with unmanaged pain, it is imperative that preterm babies receive the most effective pain-reducing treatments to improve their health outcomes. Our findings will have important implications in informing optimal pain assessment and management in preterm infants. TRIAL REGISTRATION:ClinicalTrials.gov NCT03745963 . Registered on November 19, 2018.

Objectives To define and validate types of pain in critically ill neonates and infants by researchers and clinicians working in the neonatal intensive care unit (NICU) and high dependency unit (HDU). Design A qualitative descriptive mixed-methods design. Procedure/s Each stage of the study was built on and confirmed the previous stages. Stage 1 was an expert panel to develop definitions; stage 2 was a different expert panel made up of neonatal clinicians to propose clinical characteristics associated with the definitions from stage 1; stage 3 was a focus group of neonatal clinicians to provide clinical case scenarios associated with each definition and clinical characteristics; and stage 4 was a survey administered to neonatal clinicians internationally to test the validity of the definitions using the clinical case scenarios. Results In stage 1, the panel (n=10) developed consensus definitions for acute episodic pain and chronic pain in neonates and infants. In stage 2, a panel (n=8) established clinical characteristics that may be associated with each definition. In stage 3, a focus group (n=11) created clinical case scenarios of neonates and infants with acute episodic pain, chronic pain and no pain using the definitions and clinical characteristics. In stage 4, the survey (n=182) revealed that the definitions allowed an excellent level of discrimination between case scenarios that described neonates and infants with acute episodic pain and chronic pain (area under the receiver operating characteristic=0.87 and 0.89, respectively). Conclusions This four-stage study enabled the development of consensus-based and clinically valid definitions of acute episodic pain and chronic pain. There is a need to define and validate other pain types to inform a taxonomy of pain experienced by neonates and infants in the NICU and HDU.

A major role of maternal care is to protect their infant from harm, including pain. The aim of this chapter is to review the evidence on the effectiveness of maternal strategies that are efficacious in managing procedural pain including breastfeeding, kangaroo mother care, and facsimiles of maternal presence such as voice recordings, odour, and other care providers. The mechanisms, as currently understood, underlying the efficacy of maternal care, will be presented. Finally, pragmatic issues, such as feasibility, will be discussed.

From 1980 into present day, 2020, the evolution of neonatal pain research is told as a journey by one researcher, Celeste Johnston. At the beginning of her work, there was essentially no interest or work in the area. She was fortunate to be led into the area by a clinical problem: how to determine the amount of pain babies in the NICU were experiencing. That question resulted in over three decades of work with neonates. Measuring pain was the first challenge and is one that remains a focus of current research. Initially, the only choices for treating pain in neonates were either opioids or anesthetics, each with problems. Research on sweet taste and more recently on skin-to-skin contact has offered effective and safe options for procedural pain. Although progress has been made in the incidence of pain management in infants, it still is far less than it could be. Steps along the way of measurement, treatment, and knowledge utilization are chronicled by this researcher.

This study aimed to identify the use of prone position, by physical therapy care, for infants hospitalized in an NICU in the Southern Region of Brazil.This is a cross-sectional study on a public NICU in the Southern Region of Brazil between December 2015 and May 2018, using standardized questionnaires for physical therapists.We included 44 NICU, totaling 104 professionals interviewed, the mean age of the interviewed was 33.5 years (SD: 7.1) and the mean experience time in the area was 7.7 years (SD: 6.9), and 77.9% reported to have specialization.According to 68.3% of the respondents, there is a protocol for the change of position in the Unit, but the prone position is not indicated in most NICUs (59.6%).Most of the respondents (65.4%) answered affirmatively, but 73.1% reported limitations in their incorporation into the Services, often related to aspects external to the newborn (lack of exclusive or full-time professionals in the NICU (75.0%) and a reduced number of professionals (33.6%)).The prone position is generally not indicated in the hospital (57.7%). Conclusion:The importance of the prone position is recognized, as well as its interference concerning the NPMD of newborns.However, there was a limited alternation of positions during the newborn's hospitalization, followed by a lack of emphasis on orienting the prone position to family/ caregivers.Also, a lack of exclusive or comprehensive physical therapists and the disproportion between demand and number of professionals has been observed.

Preterm neonates hospitalized in the neonatal intensive care unit undergo frequent painful procedures daily, often without pain treatment, with associated long-term adverse effects. Maternal-infant skin-to-skin contact, or kangaroo care (KC), and sweet-tasting solutions such as sucrose are effective strategies to reduce pain during a single procedure; however, evidence of sustained efficacy over repeated procedures is limited. We aimed to determine the relative sustained efficacy of maternal KC, administered alone or in combination with 24% sucrose, to reduce behavioral pain intensity associated with routine neonatal procedures, compared with 24% sucrose alone. Stable preterm infants (n = 242) were randomized to receive KC and water, KC and 24% sucrose, or 24% sucrose before all routine painful procedures throughout their neonatal intensive care unit stay. Pain intensity, determined using the Premature Infant Pain Profile, was measured during 3 medically indicated heel lances distributed across hospitalization. Maternal and neonatal baseline characteristics, Premature Infant Pain Profile scores at 30, 60, or 90 seconds after heel lance, the distribution of infants with pain scores suggesting mild, moderate, or severe pain, Neurobehavioral Assessment of the Preterm Infant scores, and incidence of adverse outcomes were not statistically significantly different between groups. Maternal KC, as a pain-relieving intervention, remained efficacious over time and repeated painful procedures without evidence of any harm or neurological impact. It seemed to be equally effective as 24% oral sucrose, and the combination of maternal KC and sucrose did not seem to provide additional benefit, challenging the existing recommendation of using sucrose as the primary standard of care.

Background: The 2018 Global Year for Excellence in Pain Education, an initiative of the International Association for the Study of Pain, brought worldwide attention to the need for education that crosses narrow disciplinary boundaries, addresses up-to-date research methods and findings, and encourages teamwork among trainees and mentors at different levels of training and with different perspectives. Aims: This commentary describes the development of Pain in Child Health (PICH), an interdisciplinary training program for researchers in pediatric pain at the undergraduate, graduate, and postdoctoral levels of training. Methods: Based on documentation of the structure, training processes, leadership, and membership of PICH, we outline its organization and its challenges and accomplishments over the first 12 years of its growth into a well-known international program. Results and Conclusions: Pain in Child Health began as a Strategic Training Initiative of the Canadian Institutes of Health Research in 2002 and developed into an international research training consortium featuring cross-site and cross-discipline mentorship and collaboration. PICH trainees and alumni have contributed extensively to the current scientific literature on children's pain. PICH could serve as a possible model for training and mentorship in other specialized health research domains within and outside thestudy of pain.

This study aimed to examine the validity of the regional cerebral oxygenation using the near infrared spectroscopy technique for pain assessment in postoperative cardiac surgery adults in the intensive care unit. The near infrared spectroscopy for the assessment of pain has been studied in pediatric population, but its use in adult population especially in the critically ill is new. A total of 125 cardiac surgery intensive care unit patients from a Canadian university-affiliated hospital participated in this prospective repeated-measures study. Six assessments were completed at rest before, during, and 15 min after two procedures: (1) non-nociceptive (blood pressure measurement using cuff inflation) and (2) nociceptive (mediastinal tube removal). Regional cerebral oxygenation (%) was measured using the INVOS 5100 device (Somanetics, Troy, MI, USA). The Critical-Care Pain Observation Tool was employed to assess behavioral responses to pain. Self-reports of pain intensity and unpleasantness using 0–10 scales were also obtained. Participants were mostly males (89%) and averaged 65 of age. Regional cerebral oxygenation showed significant mild bilateral decreases (<1%; p<0.01) while higher mean Critical-Care Pain Observation Tool scores, pain intensity, and unpleasantness self-reports were obtained during mediastinal tube removal ( p < 0.001). Only the Critical-Care Pain Observation Tool score was mildly correlated to the right side regional cerebral oxygenation ( r −0.23; p < 0.01). Changes in regional cerebral oxygenation were mild and in the opposite direction. Unfortunately, the findings do not support the clinical use of the INVOS 5100 (Somanetics, Troy, MI, USA) and its regional cerebral oxygenation hemodynamic parameter for the assessment of pain in the cardiac surgery critically ill patients.

BACKGROUND Skin-to-skin care (SSC), otherwise known as Kangaroo Care (KC) due to its similarity with marsupial behaviour of ventral maternal-infant contact, is one non-pharmacological intervention for pain control in infants. OBJECTIVES The primary objectives were to determine the effect of SSC alone on pain from medical or nursing procedures in neonates undergoing painful procedures compared to no intervention, sucrose or other analgesics, or additions to simple SSC such as rocking; and the effects of the amount of SSC (duration in minutes) and the method of administration (who provided the SSC, positioning of caregiver and neonate pair).The secondary objectives were to determine the incidence of untoward effects of SSC and to compare the SSC effect in different postmenstrual age subgroups of infants. SEARCH METHODS The standard methods of the Cochrane Neonatal Collaborative Review Group were used. Databases searched in August 2011: Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library); Evidence-Based Medicine Reviews; MEDLINE (1950 onwards); PubMed (1975 onwards); EMBASE (1974 onwards); CINAHL (1982 onwards); Web of Science (1980 onwards); LILACS database (1982 onwards); SCIELO database (1982 onwards); PsycInfo (1980 onwards); AMED (1985 onwards); Dissertation-Abstracts International (1980 onwards). Searches were conducted throughout September 2012. SELECTION CRITERIA Studies with randomisation or quasi-randomisation, double or single-blinded, involving term infants (> 37 completed weeks postmenstrual age (PMA)) to a maximum of 44 weeks PMA and preterm infants (< 37 completed weeks PMA) receiving SSC for painful procedures conducted by doctors, nurses, or other healthcare professionals. DATA COLLECTION AND ANALYSIS The main outcome measures were physiological or behavioural pain indicators and composite pain scores. A weighted mean difference (WMD) with 95% confidence interval (CI) using a fixed-effect model was reported for continuous outcome measures. We included variations on type of tissue-damaging procedure, provider of care, and duration of SSC. MAIN RESULTS Nineteen studies (n = 1594 infants) were included. Fifteen studies (n = 744) used heel lance as the painful procedure, one study combined venepuncture and heel stick (n = 50), two used intramuscular injection, and one used 'vaccination' (n = 80). The studies that were included were generally strong and free from bias.Eleven studies (n = 1363) compared SSC alone to a no-treatment control. Although 11 studies measured heart rate during painful procedures, data from only four studies (n = 121) could be combined to give a mean difference (MD) of 0.35 beats per minute (95% CI -6.01 to 6.71). Three other studies that were not included in meta-analyses also reported no difference in heart rate after the painful procedure. Two studies reported heart rate variability outcomes and found no significant differences. Five studies used the Premature Infant Pain Profile (PIPP) as a primary outcome, which favoured SCC at 30 seconds (n = 268) (MD -3.21, 95% CI -3.94 to -2.48), 60 seconds (n = 164) (MD -1.85, 95% CI -3.03 to -0.68), and 90 seconds (n = 163) (MD -1.34, 95% CI -2.56 to -0.13), but at 120 seconds (n = 157) there was no difference. No studies provided findings on return of heart rate to baseline level, oxygen saturation, cortisol levels, duration of crying, and facial actions that could be combined for analysis.Eight studies compared SSC to another intervention with or without a no-treatment control. Two cross-over studies (n = 80) compared mother versus other provider on PIPP scores at 30, 60, 90, and 120 seconds with no significant difference. When SSC was compared to other interventions, there were not enough similar studies to pool results in an analysis. One study compared SSC with and without dextrose and found that the combination was most effective and that SSC alone was more effective than dextrose alone. Similarly, in another study SSC was more effective than oral glucose for heart rate but not oxygen saturation. SSC either in combination with breastfeeding or alone was favoured over a no-treatment control, but was not different to breastfeeding. There were not enough participants with similar outcomes and painful procedures to compare age groups or duration of SSC. No adverse events were reported in any of the studies. AUTHORS' CONCLUSIONS SSC appears to be effective, as measured by composite pain indicators and including both physiological and behavioural indicators, and safe for a single painful procedure such as a heel lance. Purely behavioural indicators tended to favour SSC but there remains questionable bias regarding behavioural indicators. Physiological indicators were typically not different between conditions. Only two studies compared mother providers to others, with non-significant results. There was more heterogeneity in the studies with behavioural or composite outcomes. There is a need for replication studies that use similar, clearly defined outcomes. New studies examining optimal duration of SSC, gestational age groups, repeated use, and long-term effects of SSC are needed.

Pillai Riddell, Rebecca; Fitzgerald, Maria; Slater, Rebeccah; Stevens, Bonnie; Johnston, Celeste; Campbell-Yeo, Marsha Author Information

This review assessed how often neonates in control groups experienced unnecessary pain during clinical trials involving procedural pain. We retrieved 45 studies in the 30 months up to June 2015 and found that in 29 (64%) the control babies received either placebos or no treatment. Placebos were used in 15/25 (60%) studies involving heel pricks and in 6/8 (75%) involving venepuncture. Conclusion Despite international guidelines, neonates included in control groups during painful procedures do not receive analgesia in the majority of cases. Several historical reasons can explain this, but in the light of present knowledge, this should not continue. Ethical committees are thereof invited since now to not permit clinical trials that do not explicitly rule out pain during treatments and journals are invited to not publish them.

AimsThe aim of this study was to assess the acceptability of methods that increase trial inclusion in meta-analyses, and the level of evidence for skin-to-skin contact for procedural pain in infants.BackgroundThe current Cochrane review of skin-to-skin contact for pain in newborns found it to be an effective intervention, but identified several methodological limitations.DesignMeta-re-analysisMethodsTrial designs included randomized trials reporting a validated pain assessment tool as a primary outcome including term and pre-term infants undergoing a tissue-breaking painful procedure. The search in the original review was conducted to January 2013. Scores of validated tools were scaled to the premature infant pain profile in a fixed-effect meta-re-analysis. The GRADE was used to assess quality of meta-analysed evidence.ResultsNew analysis vs. original found a mean difference: -311 in favour of skin-to-skin contact vs. -321 at 30seconds; and -271 vs. -185 at 60seconds for heel lance. Based on cut-off scores for the Neonatal Infant Pain Scale, infants receiving skin-to-skin contact during IM injection were more likely to display low pain after injection; and during recovery.ConclusionScaling scores to a single outcome can provide additional information in meta-analyses, simplifies interpretability of pooled scores, and can improve GRADE outcomes. Sensitivity analyses of scaled scores improve confidence in their validity. Risk of bias subgroups simplified the GRADE process, and confidence intervals for heterogeneity statistics assisted in interpretation of sensitivity analyses.

Background: Skin-to-skin contact between mother and infant, commonly referred to as Kangaroo Care (KC), has demonstrated efficacy as a pain-relieving strategy for infants, yet, it remains underutilized in clinical practice. Purpose: To evaluate changes in neonatal intensive care unit staff nurse beliefs, utilization, and challenges related to practice change in implementing KC as an intervention for management of procedural pain in preterm infants between 2 time points. Methods: Nurses who participated in a larger clinical trial examining the sustained efficacy of KC were asked to complete a questionnaire at 2 time points: 1- and 6 month(s) following study initiation. Identified benefits, expectations, frequency of use, and challenges related to practice change uptake were described using frequencies and percentages. Data from the 2 different time points were compared using χ2 analysis. Results: Of the 40 nurses approached, all completed the questionnaire (19 at the 1-month and 21 at the 6-month time point). Of the sample (n = 40), 97% of participants indicated that they expected KC to provide good pain relief or better. Staff nurses reported significantly improved preconceived ideas (χ2 = 22.68, P < .01) and significantly fewer concerns (χ2 = 22.10, P = .01) related to using KC as a pain-relieving intervention between the 2 time points. No significant differences were seen in the frequency of using KC as an intervention between time points. Implications for Research and Practice: Despite increasingly positive preconceived ideas and reduced concerns, the frequency of using KC for procedural pain relief remained unchanged. Further research addressing ways to overcome barriers to utilizing KC as an intervention for procedural pain is warranted.

Introduction: A large number of patients who are in pain upon arriving at the emergency department are still in pain when they are discharged. It is suggested that nurses' personal traits and their level of empathy can explain in part this issue in pain management. The purpose of this study was to better understand the shortfalls in pain management provided by emergency nurses by considering nurses' characteristics.Methods: A cross-sectional descriptive correlational design was used for this pilot study. French validated self-administrated questionnaires (sociodemographic characteristics, empathy, psychological distress, and well-being) were presented to 40 emergency nurses. Thirty emergency nurses completed all questionnaires during work hours. Descriptive statistics, group comparisons, and correlation analyses were used for the data analysis.Results: Emergency nurses appear to have low levels of empathy. High levels of psychological distress and low levels of well-being were also observed in our sample. Among these variables, only empathy and well-being appear to be related, because we found higher empathy scores in nurses with higher well-being.Discussion: The poor mental health we found among emergency nurses is alarming. A clear need exists for supportive interventions for nurses. Finally, well-being was the only variable related to empathy. To our knowledge, this is the first study to report this relationship in nurses.

OBJECTIVE To evaluate the efficacy of cobedding on twin coregulation and twin safety. DESIGN Randomized controlled trial (RCT). SETTING Two university affiliated Level III neonatal intensive care units (NICUs). PARTICIPANTS One hundred and seventeen sets (N = 234) of stable preterm twins (<37 weeks gestational age at birth) admitted to the NICU. METHODS Sets of twins were randomly assigned to be cared for in a single cot (cobedded) or in separate cots (standard care). State response was obtained from videotaped and physiologic data measured and recorded for three, 3-hour sessions over a one-week study period. Tapes were coded for infant state by an assessor blind to the purpose of the study. RESULTS Twins who were cobedded spent more time in the same state (p < .01), less time in opposite states (p < .01), were more often in quiet sleep (p < .01) and cried less (p < .01) than twins who were cared for in separate cots. There was no difference in physiological parameters between groups (p = .85). There was no difference in patient safety between groups (incidence of sepsis, p = .95), incidence of caregiver error (p = .31), and incidence of apnea (p = .70). CONCLUSIONS Cobedding promotes self-regulation and sleep and decreases crying without apparent increased risk.

BACKGROUND:Preterm infants generally spend weeks in the neonatal intensive care unit where light intensity can fluctuate as well as be high, leading to physiological instability and increased motor activity in these infants. To date, 2 lighting control methods have been studied: cycled lighting and continuous near darkness. The most appropriate method of lighting is still unknown due to ambivalent results from the studies that have assessed these 2 interventions.OBJECTIVE:To compare the effects of cycled lighting versus continuous near darkness on physiological stability and motor activity level in preterm infants born between 28 and 32 weeks of gestation.METHODS:A randomized clinical trial was conducted to compare physiological stability and motor activity level in preterm infants assigned to cycled lighting or continuous near darkness. Thirty-eight participants were recruited and randomly assigned to one of the lighting conditions for 24 hours. Physiological stability was measured using the Stability of the Cardiorespiratory System in Premature Infants (SCRIP) score, the means, and the coefficient of variation of each physiological parameter measured. The level of motor activity was measured with an accelerometer.RESULTS:There were no significant differences between the 2 groups with regard to physiological stability measured by the SCRIP score, means, and coefficient of variation as well as motor activity level. Participants in both groups were physiologically stable and their motor activity level was comparable.IMPLICATIONS FOR PRACTICE AND RESEARCH:Neither cycled lighting nor continuous near darkness negatively impacted infant's physiologic stability and motor activity level. Further research is required to identify the most appropriate lighting control method for preterm infants born between 28 and 32 weeks of gestation.

The purpose of this study was to evaluate the pain response of 28–32 weeks gestational age preterm infants during a heel lance following a 4-h period where they had worn eye shields and earmuffs as a light and noise reduction intervention. A randomized controlled trial was conducted on 44 preterm infants recruited from four level III NICU. Heart rate and heart rate variability were collected continuously during the heel lance. At the end of the painful procedure, the time HR took to return to baseline was calculated. ANCOVA indicated that preterm infants who wore eye shields and earmuffs 4-h before the heel lance did not show a significant reduction in their pain response during the procedure in comparison to those who did not. Confounders such as handling in the hours preceding the painful procedure and the time it took to collect the blood might have influenced the results.

Extremely low gestational age infants (<28 weeks at birth) experience significant pain from repeated therapeutic procedures while hospitalized in the neonatal intensive care unit. As part of a program of research examining pain in preterm infants, we conducted a qualitatively driven mixed-methods design, supplemented with a qualitative and quantitative component, to understand how health care professionals (HCPs) assess and manage procedural pain for tiny and underdeveloped preterm infants. Fifty-nine HCPs from different disciplines across four tertiary-level neonatal units in Canada participated in individual or focus group interviews and completed a brief questionnaire. Four themes from the content analysis were (a) subtlety and unpredictability of pain indicators, (b) infant and caregiver attributes and contextual factors that influence pain response and practices, (c) the complex nature of pain assessment, and (d) uncertainty in the management of pain. The information gleaned from this study can assist in identifying gaps in knowledge and informing unit-based and organizational knowledge translation strategies for this vulnerable population.