Enhancing breast milk production with Domperidone in mothers of preterm neonates (EMPOWER trial)

BACKGROUND: The use of mother’s own breast milk during initial hospitalization has a positive impact not only in reducing potential serious neonatal morbidities but also contribute to improvements in neurodevelopmental outcomes. Mothers of very preterm infants struggle to maintain a supply of breast milk during their infants’ prolonged hospitalization. Galactogogues are medications that induce lactation by exerting its effects through oxytocin or prolactin enhancement. Domperidone is a potent dopamine D(2) receptor antagonist which stimulates the release of prolactin. Small trials have established its ability in enhancing breast milk production. EMPOWER was designed to determine the safety and efficacy of domperidone in mothers experiencing an inadequate milk supply. METHODS/DESIGN: EMPOWER is a multicenter, double masked, randomized controlled phase-II trial to evaluate the safety and effectiveness of domperidone in those mothers identified as having difficulty in breast milk production. Eligible mothers will be randomized to one of two allocated groups: Group A: domperidone 10 mg orally three times daily for 28 days; and Group B: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days. The primary outcome will be determined at the completion of the first 2-week period; the second 2-week period will facilitate answering the secondary questions regarding timing and duration of treatment. To detect an estimated 30% change between the two groups (from 40% to 28%, corresponding to an odds ratio of 0.6), a total sample size of 488 mothers would be required at 80% power and alpha = 0.05. To account for a 15% dropout, this number is increased to 560 (280 per group). The duration of the trial is expected to be 36–40 months. DISCUSSION: The use of a galactogogue often becomes the measure of choice for mothers in the presence of insufficient breast milk production, particularly when the other techniques are unsuccessful. EMPOWER is designed to provide valuable information in guiding the practices for this high-risk group of infants and mothers. The results of this trial will also inform both mothers and clinicians about the choices available to increase and maintain sufficient breast milk. TRIAL REGISTRATION: Clinical Trials.gov Identifier: NCT0151222

Implementation Effectiveness of a Parent-Directed YouTube Video ("It Doesn't Have To Hurt") on Evidence-Based Strategies to Manage Needle Pain: Descriptive Survey Study

Background: Despite the availability of high-quality evidence and clinical practice guidelines for the effective management of pediatric pain, this evidence is rarely used in practice for managing children’s pain from needle procedures such as vaccinations. Parents are generally unaware of pain management strategies they can use with their children. Objective: This study aimed to develop, implement, and evaluate the implementation effectiveness of a parent-directed YouTube video on evidence-based strategies to manage needle pain in children. Methods: This was a descriptive study. Analytics were extracted from YouTube to describe video reach. A Web-based survey was used to seek parent and health care professional (HCP) feedback about the video. The 2-minute 18-second video was launched on YouTube on November 4, 2013. In the video, a 4-year-old girl tells parents what they should and should not do to help needles hurt less. The key evidence-based messages shared in the video were distraction, deep breathing, and topical anesthetic creams. A group of parents (n=163) and HCPs (n=278) completed the Web-based survey. Measures of reach included number of unique views, country where the video was viewed, sex of the viewer, and length of watch time. The Web-based survey assessed implementation outcomes of the video, such as acceptability, appropriateness, penetration, and adoption. Results: As of November 4, 2018 (5 years after launch), the video had 237,132 unique views from 182 countries, with most viewers watching an average of 55.1% (76/138 seconds) of the video. Overall, both parents and HCPs reported strong acceptance of the video (ie, they liked the video, found it helpful, and felt more confident) and reported significant improvements in plans to use distraction, deep breathing, and topical anesthetic creams. Conclusions: This parent-directed YouTube video was an acceptable and appropriate way to disseminate evidence about the procedure of pain management to a large number of parents

Offspring of parents with chronic pain: A systematic review and meta-analysis of pain, health, psychological, and family outcomes

Offspring of parents with chronic pain may be at risk for poorer outcomes than offspring of healthy parents. The objective of this research was to provide a comprehensive mixed-methods systematic synthesis of all available research on outcomes in offspring of parents with chronic pain. A systematic search was conducted for published articles in English examining pain, health, psychological, or family outcomes in offspring of parents with chronic pain. Fifty-nine eligible articles were identified (31 population-based, 25 clinical, 3 qualitative), including offspring from birth to adulthood and parents with varying chronic pain diagnoses (eg, mixed pain samples, arthritis). Meta-analysis was used to synthesize the results from population-based and clinical studies, while meta-ethnography was used to synthesize the results of qualitative studies. Increased pain complaints were found in offspring of mothers and of fathers with chronic pain and when both parents had chronic pain. Newborns of mothers with chronic pain were more likely to have adverse birth outcomes, including low birthweight, preterm delivery, caesarian section, intensive care admission, and mortality. Offspring of parents with chronic pain had greater externalizing and internalizing problems and poorer social competence and family outcomes. No significant differences were found on teacher-reported externalizing problems. The meta-ethnography identified 6 key concepts (developing independence, developing compassion, learning about health and coping, missing out, emotional health, and struggles communicating with parents). Across study designs, offspring of parents with chronic pain had poorer outcomes than other offspring, although the meta-ethnography noted some constructive impact of having a parent with chronic pain. © 2015 International Association for the Study of Pain

Kangaroo mother care diminishes pain from heel lance in very preterm neonates: A crossover trial

BACKGROUND: Skin-to-skin contact, or kangaroo mother care (KMC) has been shown to be efficacious in diminishing pain response to heel lance in full term and moderately preterm neonates. The purpose of this study was to determine if KMC would also be efficacious in very preterm neonates. METHODS: Preterm neonates (n = 61) between 28 0/7 and 31 6/7 weeks gestational age in three Level III NICU's in Canada comprised the sample. A single-blind randomized crossover design was employed. In the experimental condition, the infant was held in KMC for 15 minutes prior to and throughout heel lance procedure. In the control condition, the infant was in prone position swaddled in a blanket in the incubator. The primary outcome was the Premature Infant Pain Profile (PIPP), which is comprised of three facial actions, maximum heart rate, minimum oxygen saturation levels from baseline in 30-second blocks from heel lance. The secondary outcome was time to recover, defined as heart rate return to baseline. Continuous video, heart rate and oxygen saturation monitoring were recorded with event markers during the procedure and were subsequently analyzed. Repeated measures analysis-of-variance was employed to generate results. RESULTS: PIPP scores at 90 seconds post lance were significantly lower in the KMC condition (8.871 (95%CI 7.852-9.889) versus 10.677 (95%CI 9.563-11.792) p < .001) and non-significant mean differences ranging from 1.2 to1.8. favoring KMC condition at 30, 60 and 120 seconds. Time to recovery was significantly shorter, by a minute(123 seconds (95%CI 103-142) versus 193 seconds (95%CI 158-227). Facial actions were highly significantly lower across all points in time reaching a two-fold difference by 120 seconds post-lance and heart rate was significantly lower across the first 90 seconds in the KMC condition. CONCLUSION: Very preterm neonates appear to have endogenous mechanisms elicited through skin-to-skin maternal contact that decrease pain response, but not as powerfully as in older preterm neonates. The shorter recovery time in KMC is clinically important in helping maintain homeostasis. TRIAL REGISTRATION: (Current Controlled Trials) ISRCTN63551708

Training highly qualified health research personnel: The Pain in Child Health consortium

Background and Objectives: Pain in Child Health (PICH) is a transdisciplinary, international research training consortium. PICH has been funded since 2002 as a Strategic Training Initiative in Health Research of the Canadian Institutes of Health Research, with contributions from other funding partners and the founding participation of five Canadian universities. The goal of PICH has been to create a community of scholars in pediatric pain to improve child health outcomes. Methods: Quantitative analyses enumerated PICH faculty, trainees, training activities and scientific outputs. Interviews with PICH stakeholders were analyzed using qualitative methods capturing perceptions of the program’s strengths, limitations, and opportunities for development and sustainability. Results : PICH has supported 218 trainee members from 2002 through 2013, from 14 countries and more than 16 disciplines. The faculty at the end of 2013 comprised nine co-principal investigators, 14 Canadian coinvestigators, and 28 Canadian and international collaborators. Trainee members published 697 peer-reviewed journal articles on pediatric pain through 2013, among other research dissemination activities including conference presentations and webinars. Networks have been established between new and established researchers across Canada and in 13 other countries. Perceptions from stakeholders commended PICH for its positive impact on the development of pediatric pain researchers. Stakeholders emphasized skills and abilities gained through PICH, the perceived impact of PICH training on this research field, and considerations for future training in developing researchers in pediatric pain. Conclusions: PICH has been successfully developing highly qualified health research personnel within a Canadian and international community of pediatric pain scholarship

A comprehensive categorical and bibliometric analysis of published research articles on pediatric pain from 1975 to 2010

The field of pediatric pain research began in the mid-1970s and has undergone significant growth and development in recent years as evidenced by the variety of books, conferences, and journals on the topic and also the number of disciplines engaged in work in this area. Using categorical and bibliometric meta-trend analysis, this study offers a synthesis of research on pediatric pain published between 1975 and 2010 in peer-reviewed journals. Abstracts from 4256 articles, retrieved from Web of Science, were coded across 4 categories: article type, article topic, type and age of participants, and pain stimulus. The affiliation of the first author and number of citations were also gathered. The results suggest a significant increase in the number of publications over the time period investigated, with 96% of the included articles published since 1990 and most research being multiauthored publications in pain-focused journals. First authors were most often from the United States and affiliated with a medical department. Most studies were original research articles; the most frequent topics were pain characterization (39.86%), pain intervention (37.49%), and pain assessment (25.00%). Clinical samples were most frequent, with participants most often characterized as children (6-12 years) or adolescents (13-18 years) experiencing chronic or acute pain. The findings provide a comprehensive overview of contributions in the field of pediatric pain research over 35 years and offers recommendations for future research in the area. © 2015 International Association for the Study of Pain

What is the definition of acute episodic and chronic pain in critically ill neonates and infants? : a global, four-stage consensus and validation study

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

Cultural adaptation and harmonization of four Nordic translations of the revised Premature Infant Pain Profile (PIPP-R)

Publisher's version (útgefin grein)Background: Preterm infants are especially vulnerable to pain. The intensive treatment often necessary for their survival unfortunately includes many painful interventions and procedures. Untreated pain can lead to both shortand long-term negative effects. The challenge of accurately detecting pain has been cited as a major reason for lack of pain management in these non-verbal patients. The Premature Infant Pain Profile (PIPP) is one of the most extensively validated measures for assessing procedural pain in premature infants. A revised version, PIPP-R, was recently published and is reported to be more user-friendly and precise than the original version. The aims of the study were to develop translated versions of the PIPP-R in Finnish, Icelandic, Norwegian, and Swedish languages, and to establish their content validity through a cultural adaptation process using cognitive interviews. Methods: PIPP-R was translated using the recommendations from the International Society for Pharmacoeconomics and Outcomes Research and enhanced with cognitive interviews. The respondent nurse was given a copy of the translated, national version of the measure and used this together with a text describing the infant in the film to assess the pain of an infant in a short film. During the assessment the nurse was asked to verbalize her thought process (thinking aloud) and upon completion the interviewer administered probing questions (verbal probing) from a structured interview guide. The interviews were recorded, transcribed, and analyzed using a structured matrix approach. Results: The systematic approach resulted in translated and culturally adapted versions of PIPP-R in the Finnish, Icelandic, Norwegian and Swedish languages. During the cultural adaptation process several problems were discovered regarding how the respondent understood and utilized the measure. The problems were either measure problems or other problems. Measure problems were solved by a change in the translated versions of the measure, while for other problems different solutions such as education or training were suggested. Conclusions: This study have resulted in translations of the PIPP-R that have content validity, high degree of clinical utility and displayed beginning equivalence with each other and the original version of the measure.Not applicable.Peer Reviewe

Cultural adaptation and harmonization of four Nordic translations of the revised Premature Infant Pain Profile (PIPP-R)

BackgroundPreterm infants are especially vulnerable to pain. The intensive treatment often necessary for their survival unfortunately includes many painful interventions and procedures. Untreated pain can lead to both short- and long-term negative effects. The challenge of accurately detecting pain has been cited as a major reason for lack of pain management in these non-verbal patients. The Premature Infant Pain Profile (PIPP) is one of the most extensively validated measures for assessing procedural pain in premature infants. A revised version, PIPP-R, was recently published and is reported to be more user-friendly and precise than the original version. The aims of the study were to develop translated versions of the PIPP-R in Finnish, Icelandic, Norwegian, and Swedish languages, and to establish their content validity through a cultural adaptation process using cognitive interviews.MethodsPIPP-R was translated using the recommendations from the International Society for Pharmacoeconomics and Outcomes Research and enhanced with cognitive interviews. The respondent nurse was given a copy of the translated, national version of the measure and used this together with a text describing the infant in the film to assess the pain of an infant in a short film. During the assessment the nurse was asked to verbalize her thought process (thinking aloud) and upon completion the interviewer administered probing questions (verbal probing) from a structured interview guide. The interviews were recorded, transcribed, and analyzed using a structured matrix approach.ResultsThe systematic approach resulted in translated and culturally adapted versions of PIPP-R in the Finnish, Icelandic, Norwegian and Swedish languages. During the cultural adaptation process several problems were discovered regarding how the respondent understood and utilized the measure. The problems were either measure problems or other problems. Measure problems were solved by a change in the translated versions of the measure, while for other problems different solutions such as education or training were suggested.ConclusionsThis study have resulted in translations of the PIPP-R that have content validity, high degree of clinical utility and displayed beginning equivalence with each other and the original version of the measure.</p