Clonidine as analgesia during retinopathy of prematurity screening in preterm infants (cloROP): protocol for a randomised controlled trial.

INTRODUCTION: Preterm infants are at risk of negative consequences from stress and pain at the same time as they often are in need of intensive care that includes painful interventions. One of the frequent painful procedures preterm infants undergo is eye examination screening to detect early signs of ROP (retinopathy of prematurity). These examinations are both stressful and painful, and despite a multitude of research studies, no conclusive pain-relieving treatment has been demonstrated. The main aim of this trial is to investigate the analgesic effect of clonidine during ROP eye examinations. METHODS AND ANALYSIS: The planned study is a multicentre randomised controlled trial with a crossover design. Infants will be recruited from two different neonatal intensive care units (NICUs) in Sweden. Infants born before gestation week 30 (and therefore eligible for ROP screening) and cared for in either of the NICUs will be eligible for inclusion in the study. The primary outcome will be Premature Infant Pain Profile-Revised score within 30 s after starting the examination. Secondary outcomes will be changes in the galvanic skin response parameters (area small peaks, area huge peaks, peaks per second and average rise time) within 30 s after starting the eye examination, together with the number and evaluation of adverse events reported within 72 hours after the examination and the examining physician's assessment of how easy the infant was to examine. ETHICS AND DISSEMINATION: Approval from the Swedish Ethical Review Authority and the Swedish Medical Products Agency has been obtained for the study. Parents of eligible infants will be getting both verbal and written information about the study including that participation is voluntary. Data will be collected and treated in accordance with the European general data protection regulations. The results will be reported on group level and published in a scientific journal. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (NCT04902859).EudraCT (2021-003005-21).

Nurses' perception, knowledge, and use of neonatal pain assessment.

Preterm and sick newborn infants undergo several painful procedures during their hospital stay, potentially leading to short- and long-term negative consequences. Pain assessment should be performed regularly to provide optimal pain management. Nurses' knowledge of and attitude toward neonatal pain assessment affect how pain is assessed and managed in the clinical situation. The aim of this study was to explore Swedish nurses' perception, knowledge, and use of neonatal pain assessment. This descriptive, cross-sectional questionnaire study was conducted across all Swedish neonatal units (n = 38). Respondents were chosen through convenience sampling by the head nurses at each unit. Ten nurses from each unit were asked to complete the survey, which contained both closed and open questions. A majority of the units (30/38; 79%) participated and 232 surveys were returned, a response rate of 61%. Of the nurses, 91% thought that neonatal pain assessment was important. Many nurses mentioned various difficulties with pain assessment and concerns that the scales used might not assess pain correctly. About half of the nurses considered themselves to have enough knowledge of neonatal pain assessment. Those who reported having enough knowledge of pain assessment viewed the pain scales used at their units more positively. Of the nurses, 74% reported using a pain assessment scale several times per work shift. Pain management guidelines were available according to 75% of nurses, but only 53% reported that the guidelines were followed. Although nurses in general expressed a positive attitude toward pain assessment scales, this was not necessarily evident in their clinical practice. Lack of knowledge, available or accessible guidelines, or concerns regarding the validity of available pain scales seemed to limit their use.

Study protocol: parents as pain management in Swedish neonatal care - SWEpap, a multi-center randomized controlled trial.

BACKGROUND: During the first period of life, critically ill as well as healthy newborn infants experience recurrent painful procedures. Parents are a valuable but often overlooked resource in procedural pain management in newborns. Interventions to improve parents' knowledge and involvement in infants' pain management are essential to implement in the care of the newborn infant. Neonatal pain research has studied a range of non-pharmacological pain alleviating strategies during painful procedures, yet, regarding combined multisensorial parent-driven non-pharmacological pain management, research is still lacking. METHODS/DESIGN: A multi-center randomized controlled trial (RCT) with three parallel groups with the allocation ratio 1:1:1 is planned. The RCT "Parents as pain management in Swedish neonatal care - SWEpap", will investigate the efficacy of combined pain management with skin-to-skin contact, breastfeeding and live parental lullaby singing compared with standard pain care initiated by health care professionals, during routine metabolic screening of newborn infants (PKU-test). DISCUSSION: Parental involvement in neonatal pain management enables a range of comforting parental interventions such as skin-to-skin contact, breastfeeding, rocking and soothing vocalizations. To date, few studies have been published examining the efficacy of combined multisensorial parent-driven interventions. So far, research shows that the use of combined parent-driven pain management such as skin-to-skin contact and breastfeeding, is more effective in reducing behavioral responses to pain in infants, than using the pain-relieving interventions alone. Combined parental soothing behaviors that provide rhythmic (holding/rocking/vocalizing) or orogustatory/orotactile (feeding/pacifying) stimulation that keep the parent close to the infant, are more effective in a painful context. In the SWEpap study we also include parental live lullaby singing, which is an unexplored but promising biopsychosocial, multimodal and multisensory pain alleviating adjuvant, especially in combination with skin-to-skin contact and breastfeeding. TRIAL REGISTRATION: ClinicalTrials.gov ( NCT04341194 ) 10 April 2020.