Cumulative sucrose exposure for repeated procedural pain in preterm neonates and neurodevelopment at 18 months of corrected age: a prospective observational longitudinal study.

INTRODUCTION: Oral sucrose is repeatedly administered to neonates in the neonatal intensive care unit (NICU) to treat pain from commonly performed procedures; however, there is limited evidence on its long-term cumulative effect on neurodevelopment. We examined the association between total sucrose volumes administered to preterm neonates for pain mitigation in the NICU and their neurodevelopment at 18 months of corrected age (CA). METHODS: A prospective longitudinal single-arm observational study that enrolled hospitalised preterm neonates <32 weeks of gestational age at birth and <10 days of life was conducted in four level III NICUs in Canada. Neonates received 0.1 mL of 24% sucrose 2 min prior to all commonly performed painful procedures during their NICU stay. Neurodevelopment was assessed at 18 months of CA using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III). Multiple neonatal and maternal factors known to affect development were adjusted for in the generalised linear model analysis. RESULTS: 172 preterm neonates were enrolled and 118 were included in the analysis at 18 months of CA. The total mean sucrose volume administered/neonate/NICU stay was 5.96 (±5.6) mL, and the mean Bayley-III composite scores were: cognitive 91 (±17), language 86 (±18) and motor 88 (±18). There was no association between Bayley-III scores and the total sucrose volume: cognitive (p=0.57), language (p=0.42) and motor (p=0.70). CONCLUSION: Cumulative sucrose exposure for repeated procedural pain in preterm neonates was neither associated with a delay in neurodevelopment nor neuroprotective effects at 18 months of CA. If sucrose is used, we suggest the minimally effective dose combined with other non-pharmacological interventions with demonstrated effectiveness such as skin-to-skin contact, non-nutritive sucking, facilitated tucking and swaddling. TRIAL REGISTRATION NUMBER: NCT02725814.

A longitudinal observational study on the epidemiology of painful procedures and sucrose administration in hospitalized preterm neonates.

Although sucrose is widely administered to hospitalized infants for single painful procedures, total sucrose volume during the entire neonatal intensive care unit (NICU) stay and associated adverse events are unknown. In a longitudinal observation study, we aimed to quantify and contextualize sucrose administration during the NICU stay. Specifically, we investigated the frequency, nature, and severity of painful procedures; proportion of procedures where neonates received sucrose; total volume of sucrose administered for painful procedures; and incidence and type of adverse events. Neonates <32 weeks gestational age at birth and <10 days of life were recruited from four Canadian tertiary NICUs. Daily chart reviews of documented painful procedures, sucrose administration, and any associated adverse events were undertaken. One hundred sixty-eight neonates underwent a total of 9093 skin-breaking procedures (mean 54.1 [±65.2] procedures/neonate or 1.1 [±0.9] procedures/day/neonate) during an average NICU stay of 45.9 (±31.4) days. Pain severity was recorded for 5399/9093 (59.4%) of the painful procedures; the majority (5051 [93.5%]) were heel lances of moderate pain intensity. Sucrose was administered for 7839/9093 (86.2%) of painful procedures. The total average sucrose volume was 5.5 (±5.4) mL/neonate or 0.11 (±0.08) mL/neonate/day. Infants experienced an average of 7.9 (±12.7) minor adverse events associated with pain and/or sucrose administration that resolved without intervention. The total number of painful procedures, sucrose volume, and incidence of adverse events throughout the NICU stay were described addressing an important knowledge gap in neonatal pain. These data provide a baseline for examining the association between total sucrose volume during NICU stay and research on longer-term behavioral and neurodevelopmental outcomes.

The effectiveness of repeated sucrose for procedural pain in neonates in a longitudinal observational study.

Goal: To determine the analgesic effectiveness of repeated sucrose administration for skin-breaking (SB) procedures over the Neonatal Intensive Care Unit (NICU) hospitalization of preterm infants. Methods: Longitudinal observational study, conducted in four level III Canadian NICUs. Eligible infants were <32 weeks gestational age at birth, and <10 days of life at enrollment. Infants received 24% sucrose (0.12 ml) prior to all painful procedures. The Premature Infant Pain Profile - Revised (PIPP-R) was used at 30 and 60 seconds after a medically-required SB procedure as soon as possible after enrollment and weekly up to three additional times for scheduled procedures. Results: 172 infants (57.3% male, gestational age 28.35 (±2.31) weeks) were included. The mean 30 s PIPP-R scores were 6.11 (±3.68), 5.76 (±3.41), 6.48 (±3.67), and 6.81 (±3.69) respectively; there were no statistically significant interactions of study site by time (p = 0.31) or over time (p = 0.15). At 60 s, mean PIPP-R scores were 6.05 (±4.09), 5.74 (±3.67), 6.19 (±3.7), and 5.99 (±3.76) respectively; there were no study site by time interactions (p = 0.14) or differences over time (p = 0.52). There was a statistically significant site difference in the effectiveness of sucrose at 30 and 60 seconds (p < 0.01). Conclusions: Consistently low PIPP-R scores following a skin-breaking procedure indicated that the analgesic effectiveness of the minimal dose of sucrose was sustained over time in the NICU. Further research is required to determine the optimal combination of sucrose and other pain management strategies to improve clinical practice and the impact of consistent use of repeated use of sucrose on neurodevelopment.

Evaluation of the Premature Infant Pain Profile-Revised (PIPP-R) e-Learning Module: Immediate and Sustained Competency.

BACKGROUND: Electronic health (e-health) learning is a potential avenue to educate health professionals about accurately using infant pain assessment tools, although little is known about the impact of e-health interventions on clinical competence. PURPOSE: To evaluate whether an e-health learning module for teaching the accurate use of the Premature Infant Pain Profile-Revised (PIPP-R) pain assessment tool results in immediate and sustained competency to assess infant pain. METHODS: Neonatal intensive care unit (NICU) nurses who participated in a larger study across 2 tertiary NICUs in Canada examining the implementation and clinical utility of the PIPP-R e-learning module completed 2 follow-up evaluations at 1 week and 3 months. Participants were asked to view a video recording of an infant undergoing a painful procedure and to assess the infant's pain intensity response using the PIPP-R measure. Immediate and sustained competency was assessed via interrater consensus of participant-reported PIPP-R scores compared with those of an experienced trained coder. RESULTS: Of the 25 eligible nurses, 22 completed 1-week and 3-month follow-up evaluations. At the 1-week follow-up, 84% of nurses scored the video accurately compared with 50% at 3 months. Behavioral pain indicators were more likely to be scored incorrectly than physiological indicators. IMPLICATIONS FOR PRACTICE: Follow-up training after completion of the initial e-learning module training may improve competency related to the clinical use of the PIPP-R tool to assess infant pain over time. IMPLICATIONS FOR RESEARCH: Additional study regarding the need and timing of e-health training to optimize sustained competency in infant pain assessment is warranted.

Implementation and Evaluation of the Premature Infant Pain Profile-revised (PIPP-R) e-Learning Module for Assessing Pain in Infants.

OBJECTIVES: The Premature Infant Pain Profile-revised (PIPP-R) is a well-established measure for infant pain assessment. The aim of this study was to evaluate the implementation and clinical utility of the PIPP-R electronic learning (e-Learning) module to promote standardized health care training for nurses. MATERIALS AND METHODS: A descriptive mixed-methods study was conducted in 2 tertiary Neonatal Intensive Care Units in Canada. Nurses were recruited and asked to complete the PIPP-R e-Learning Module and evaluate it. A 26-item questionnaire was used to describe nurse demographics and clinical experience and to evaluate implementation success (ie, acceptability, feasibility, usability) and clinical utility. RESULTS: In all, 98 nurses from 2 settings in Central and Eastern Canada participated; most were registered nurses highly experienced in neonatal nursing care. The majority had received previous training on the PIPP-R (61.2%) and routinely used it in practice (67.4%). They considered the e-Learning module as acceptable and feasible as it was easy to access (94.9%) and to navigate (94.8%). Content was considered clear (98.9%) and met users' learning needs (99.0%). Nurses agreed that completing the module improved their understanding of neonatal pain (96.0%) and was clinically useful in improving their ability to assess pain in neonates (97.9%). The module was accessed primarily from work settings (77.8%) using desktop computers (49.0%) or tablets (28.0%) and was usually completed in a single session (75.7%). DISCUSSION: Nurses' evaluation of the PIPP-R e-Learning module was overwhelmingly positive. The module was perceived as easy to implement, clinically useful, and was considered as a promising online educational tool. Further testing in clinical practice is needed to build on the results of this study and support the importance of dissemination of this module for standardized training purposes.

A cluster randomized clinical trial to evaluate the effectiveness of the Implementation of Infant Pain Practice Change (ImPaC) Resource to improve pain practices in hospitalized infants: a study protocol.

BACKGROUND: Hospitalized infants undergo multiple painful procedures daily. Despite the significant evidence, procedural pain assessment and management continues to be suboptimal. Repetitive and untreated pain at this vital developmental juncture is associated with negative behavioral and neurodevelopmental consequences. To address this knowledge to practice gap, we developed the web-based Implementation of Infant Pain Practice Change (ImPaC) Resource to guide change in healthcare professionals' pain practice behaviors. This protocol describes the evaluation of the intervention effectiveness and implementation of the Resource and how organizational context influences outcomes. METHODS: An effectiveness-implementation hybrid type 1 design, blending a cluster randomized clinical trial and a mixed-methods implementation study will be used. Eighteen Neonatal Intensive Care Units (NICUs) across Canada will be randomized to intervention (INT) or standard practice (SP) groups. NICUs in the INT group will receive the Resource for six months; those in the SP group will continue with practice as usual and will be offered the Resource after a six-month waiting period. Data analysts will be blinded to group allocation. To address the intervention effectiveness, the INT and SP groups will be compared on clinical outcomes including the proportion of infants who have procedural pain assessed and managed, and the frequency and nature of painful procedures. Data will be collected at baseline (before randomization) and at completion of the intervention (six months). Implementation outcomes (feasibility, fidelity, implementation cost, and reach) will be measured at completion of the intervention. Sustainability will be assessed at six and 12 months following the intervention. Organizational context will be assessed to examine its influence on intervention and implementation outcomes. DISCUSSION: This mixed-methods study aims to determine the effectiveness and the implementation of a multifaceted online strategy for changing healthcare professionals' pain practices for hospitalized infants. Implementation strategies that are easily and effectively implemented are important for sustained change. The results will inform healthcare professionals and decision-makers on how to address the challenges of implementing the Resource within various organizational contexts. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03825822. Registered 31 January 2019.

Usability, acceptability, and feasibility of the Implementation of Infant Pain Practice Change (ImPaC) Resource.

The Implementation of Infant Pain Practice (ImPaC) Resource is an eHealth tool designed to support infant pain practice change and ultimately enhance pain outcomes. The aim of this study was to determine users' perspectives on usability, acceptability, and feasibility of the ImPaC Resource. A descriptive prospective mixed-methods quality improvement study was conducted at a pediatric hospital in Canada. Individual "think aloud" interviews were conducted in a nonclinical environment (Phase A); "near live" testing was conducted while users interacted with the Resource in clinical setting (Phase B); individual "think-aloud" interviews were conducted in a nonclinical environment (Phase C). Outcomes included usability (System Usability Scale-SUS), acceptability (Acceptability E-Scale-AES), and feasibility. Interview transcripts were coded per a priori themes using deductive content analysis to create a structured categorization matrix. In Phase A, 10 clinicians interacted with the Resource in individual sessions. Median SUS score was 73.75 (range 52.5-92.5). In Phase B, four clinicians implemented the Resource in the neonatal intensive care unit (NICU) over 4 months. Median SUS score was 85 (82.5-92.5), and median AES score was 24 (21-24). In Phase C, an enhanced prototype was produced, and the same users from Phase B navigated the Resource in individual sessions. Median SUS score was 88.75 (85-95), and median AES score was 27.5 (25-29). Users considered the Resource as feasible for implementation, easy to navigate, engaging, intuitive, comprehensive, and evidence-based. Users highlighted the potential transferability of the Resource to other contexts and settings. The enhanced version of the ImPaC Resource was usable, acceptable, feasible, and met users' expectations and requirements. Results lead the way for evaluation of the Resource in a nationwide cluster randomized trial including 18 NICUs. This knowledge-rich platform is expected to enhance infant pain practices and outcomes in diverse clinical settings.

The minimally effective dose of sucrose for procedural pain relief in neonates: a randomized controlled trial.

BACKGROUND: Orally administered sucrose is effective and safe in reducing pain intensity during single, tissue-damaging procedures in neonates, and is commonly recommended in neonatal pain guidelines. However, there is wide variability in sucrose doses examined in research, and more than a 20-fold variation across neonatal care settings. The aim of this study was to determine the minimally effective dose of 24% sucrose for reducing pain in hospitalized neonates undergoing a single skin-breaking heel lance procedure. METHODS: A total of 245 neonates from 4 Canadian tertiary neonatal intensive care units (NICUs), born between 24 and 42 weeks gestational age (GA), were prospectively randomized to receive one of three doses of 24% sucrose, plus non-nutritive sucking/pacifier, 2 min before a routine heel lance: 0.1 ml (Group 1; n = 81), 0.5 ml (Group 2; n = 81), or 1.0 ml (Group 3; n = 83). The primary outcome was pain intensity measured at 30 and 60 s following the heel lance, using the Premature Infant Pain Profile-Revised (PIPP-R). The secondary outcome was the incidence of adverse events. Analysis of covariance models, adjusting for GA and study site examined between group differences in pain intensity across intervention groups. RESULTS: There was no difference in mean pain intensity PIPP-R scores between treatment groups at 30 s (P = .97) and 60 s (P = .93); however, pain was not fully eliminated during the heel lance procedure. There were 5 reported adverse events among 5/245 (2.0%) neonates, with no significant differences in the proportion of events by sucrose dose (P = .62). All events resolved spontaneously without medical intervention. CONCLUSIONS: The minimally effective dose of 24% sucrose required to treat pain associated with a single heel lance in neonates was 0.1 ml. Further evaluation regarding the sustained effectiveness of this dose in reducing pain intensity in neonates for repeated painful procedures is warranted. TRIAL REGISTRATION: ClinicalTrials.gov : NCT02134873. Date: May 5, 2014 (retrospectively registered).

The influence of context on pain practices in the NICU: perceptions of health care professionals.

In this qualitative descriptive study, we explored health care professionals' perceptions of the influence of context (i.e., organizational culture, structure, resources, capabilities/competencies, and politics) on evidence-based pain practices. A total of 16 focus groups with 147 health care professionals were conducted in three neonatal intensive care units (NICUs) in central and eastern Canada. Three overarching themes emerged from the data, which captured influences on optimal pain practices in the NICU, including (a) a culture of collaboration and support for evidence-based practice, (b) threats to autonomous decision making, and (c) complexities in care delivery. These results were consistent with theoretical conceptualizations of how context influences practice, as well as recent empirical research findings. This study supports the importance of context in shaping evidence-based practices by health care professionals in the management of pain in the NICU.