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Scoring form for COMFORTneo.  

Scoring form for COMFORTneo.  

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Objectives: Pain assessment is essential to tailor intensive care of neonates. The present focus. is on acute procedural pain; assessment of pain of longer duration remains a challenge. We therefore tested a modified version of the COMFORT-behavior scale-named COMFORTneo-for its psychometric qualities in the Neonatal Intensive Care Unit setting. Me...

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Purpose of review With heightened awareness of long-term neurocognitive effects of pain and stress in the neonatal population, increased focus has been placed on pain assessment as well as potential effects of routinely administered analgesics/sedatives in our neonatal intensive care units (NICUs). Our goal was to review recently published literatu...

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... Achieving the optimal score of points (COMFORT-neo scale in intubated patients (13) and Neonatal Infant Pain Scale (NIPS) in extubated patients) (14) allowed a reduction in opioids (morphine infusion) or sedatives (midazolam infusion) according to the attending physician. Otherwise, a bolus of morphine was administered, or the dose of the analgesic drugs was increased. ...
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Background: Differences in neonatal pharmacokinetics are known to cause systemic accumulation of levobupivacaine with adverse effects during epidural analgesia. Therefore, it is not recommended to surpass 48 hours of administration in neonates. Free and total levobupivacaine levels are considered as predictors of toxicity. Objective: The aim of the LEVON pilot study was to detect the accumulation of levobupivacaine during epidural analgesia exceeding 48 hours in neonates. Methods: Ten neonates received a loading dose of levobupivacaine (1.25 mg/kg) followed by a continuous infusion (0.2 mg/kg/hour) epidurally. Free and total levobupivacaine concentrations were measured 0.5, 1, 6, 12, 36, 72 and 144 hours after the start of infusion. Cumulative doses of levobupivacaine, pain scores and clinical signs of toxicity were used for assessing efficacy and safety. Results: The median concentrations of total levobupivacaine were 586.0, 563.0, 837.5, 957.0, 1930.0, 708.5 and 357.5 ng/ml. The median concentrations of free levobupivacaine were 4.0, 3.6, 5.5, 3.6, 5.5, 0.8 and 0.0 ng/ml. Three patients reached concerning concentrations of total levobupivacaine. Levels of free levobupivacaine remained low. No signs of toxicity were observed. Conclusion: Caudal epidural analgesia with levobupivacaine lasting longer than 48 hours appears to be safe providing that free levobupivacaine levels are below the presumed threshold for toxicity (Tab. 1, Fig. 1, Ref. 29). Text in PDF www.elis.sk Keywords: free levobupivacaine, total levobupivacaine, neonate, caudal continuous epidural analgesia, postoperative pain.
... 22 However, if the deep sleep exceeds 12 h, gradual reduction of medication dose should be considered. 23 Ittakes2hoftrainingtoproficiently use the scale for evaluation. Neonates need to be observed 2 min before the evaluation and evaluated regularly after the intervention. ...
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Neonatal pain is a problem that is easily overlooked. According to the status quo of neonatal pain management, commonly 9 scales are used for evaluation of neonatal pain; details of the specific indicators, such as the applicable neonatal gestational age range, score, and the type of pain, for the domestic references are provided so as to provide reference for the proper evaluation and standardized management of neonatal pain, as well as to promote the management level of neonatal pain.
... The total COMFORFTneo score can vary from 6 to 30 points. Neonates with a COMFORTneo score > 14 are suspected of having pain and/or discomfort and corresponds to a score of four and higher of the Numeric Rating Scale [15]. ...
... Paracetamol was started if neonates had a COMFORTneo score of > 14 or post-operative pain was expected before surgery. Pain scores of the validated COMFORTneo scale were used to determine the degree of discomfort and pain [15]. Analgesic e cacy was de ned as a decrease in pain, calculated as the difference in COMFORTneo score before start and after the fth dose of paracetamol. ...
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Background Measuring concentrations of paracetamol could be a strategy to better understand the concentration-response profile for pain treatment in preterm and term neonates. It is not known if the serum trough concentration of paracetamol at steady state conditions is associated with a decrease in pain in this population. Low trough concentration could result in inadequate pain relief, like end-of-dose pain. Aim The aim of this study was to determine the association between the serum trough concentration of paracetamol and pain reduction in preterm and term neonates. Method In this retrospective observational study a hospital database was used to select neonates who were treated with paracetamol intravenously or rectally for at least 48 hours. Linear regression was performed to determine if serum trough concentration of paracetamol at steady state conditions was a predictor for pain reduction. Pain reduction was defined as the difference between COMFORTneo scores before start and after the fifth dose of paracetamol. Results 21 neonates were included for determining the association between serum trough concentration paracetamol and pain reduction. The median (IQR) of serum trough concentration of paracetamol after the fifth dose was 4.5 mg/L (2.7–8.5 mg/L). At steady state conditions the serum trough concentration of paracetamol was not a significant predictor of pain reduction in preterm and term neonates (p = 0.79 for preterm neonates and p = 0.49 for term neonates). Conclusion No association was found between the serum trough concentration of paracetamol at steady state conditions and pain reduction in preterm and term neonates.
... 20 Prolonged pain can also be assessed with the COMFORTneo, which is an adaptation of the COM-FORT scale for preterm infants. 21 In France, 2 scales for preterm infants have been developed. The Douleur Aiguë du Nouveau-Né (DAN) (newborn acute pain) measures acute pain, 22 while the Echelle Douleur Inconfort Nouveau-Né (EDIN) (newborn pain and discomfort scale) measures prolonged pain. ...
Article
In the neonatal intensive care unit, preterm infants undergo many painful procedures. Although these can impair their neurodevelopment if not properly managed, only half of the painful procedures are optimally handled. This cross-sectional study aimed to evaluate nurses' perceptions of preterm infants' pain, to evaluate nurses' pain assessment and management practices, as well as to identify the individual and contextual factors that influence nurses' assessments and interventions for pain management. Secondary analyses, including a mixed-model analysis, were performed with data from a larger study (n = 202 nurses). Nurses were found to have attitudes and perceptions in favor of preterm infants' pain management, although they reported using few standardized instruments to assess pain. Nurses stated that they widely used sucrose, non-nutritive sucking, and positioning as pain management interventions, while skin-to-skin contact was rarely practiced. Nurses' attitudes and perceptions influenced their pain assessment practices, which predicted their implementation of interventions. Several contextual (country, level of care, and work shift) and individual factors (age, level of education, had a preterm infant, perceptions of family-centered care, and skin-to-skin contact) also predicted nurses' pain assessment and management practices.
... Obvious pain assessment is a part of the nurses' daily documentation evaluated at least once every 3-6 h. COMFORTneo is a validated pain score even for very premature neonates, consisting of 6 behavioral items (alertness, calmness/agitation; crying/breathing reaction in ventilated patients; movements; muscle tone; and facial tension) (17). In our unit protocol, a target score range of 9-14 was used. ...
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Background Intravenous paracetamol added to morphine reduces postoperative morphine consumption in (near)term neonates. However, there are only sparse data on intravenous paracetamol as multimodal strategy in extremely low birth weight (ELBW) neonates.Objectives This study aims to assess the effects of rescue intravenous paracetamol on postoperative pain management (≤48 h postoperatively) in relation to both analgesic efficacy (validated pain assessment, drug consumption, adequate rescue medication) and safety (hypotension and bradycardia). This rescue practice was part of a standardized pain management approach in a single neonatal intensive care unit (NICU).MethodsA single-center retrospective observational study included 20 ELBW neonates, who underwent major abdominal surgery. The primary endpoints of the postoperative study period were pain intensity, over-sedation, time to first rescue analgesic dose, and the effect of paracetamol on opiate consumption. Secondary endpoints were safety parameters (hypotension, bradycardia). And as tertiary endpoints, the determinants of long-term outcome were evaluated (i.e., duration of mechanical ventilation, intraventricular hemorrhage - IVH, periventricular leukomalacia - PVL, postnatal growth restriction, stage of chronic lung disease – CLD or neurodevelopmental outcome according to Bayley-II Scales of Infant Development at 18–24 months).ResultsAll neonates received continuous opioids (sufentanil or morphine) and 13/20 also intravenous paracetamol as rescue pain medication during a 48-h postoperative period. Although opioid consumption was equal in the non-paracetamol and the paracetamol group over 48 h, the non-paracetamol group was characterized by oversedation (COMFORTneo < 9), a higher incidence of severe hypotension, and younger postnatal age (p < 0.05). All long-term outcome findings were similar between both groups.Conclusions Our study focused on postoperative pain management in ELBW neonates, and showed that intravenous paracetamol seems to be safe. Prospective validation of dosage regimens of analgesic drugs is needed to achieve efficacy goals.
... The primary outcome was the asynchrony index as previously defined in the literature [22][23][24] (definition and illustrations in the online supplement). Secondary Outcomes Secondary outcomes were each asynchrony, peak and minimal Edi, swing Edi, apnoea, desaturations, bradycardias, heart rate, respiratory rate, COMFORTneo score [25], and TcPCO 2 (detailed definitions in the online supplement). ...
Article
Introduction: Synchronization of non-invasive ventilation is challenging in extremely premature infants. We compared patient-ventilator synchrony between non-invasive neurally adjusted ventilatory assist (NIV-NAVA) using transdiaphragmatic (Edi) catheter and synchronized intermittent positive airway pressure (SiPAP) using an abdominal trigger. Methods: This study was a monocentric, randomized, crossover trial in premature infants born before 28 weeks of gestation, aged 3 days or more, and below 32 weeks postmenstrual age. NIV-NAVA and SiPAP were applied in a random order for 2 h with analysis of data from the second hour. The primary outcome was the asynchrony index. Results: Fourteen patients were included (median [IQR] gestational age at birth 25.6 (25.3-26.4) weeks, median [IQR] birth weight 755 [680-824] g, median [IQR] postnatal age 26.5 [19.8-33.8] days). The median (IQR) asynchrony index was significantly lower in NIV-NAVA versus SiPAP (49.9% [44.1-52.6] vs. 85.8% [74.2-90.9], p < 0.001). Ineffective efforts and auto-triggering were significantly less frequent in NIV-NAVA versus SiPAP (3.0% vs. 32.0% p < 0.001 and 10.0% vs. 26.6%, p = 0.004, respectively). Double triggering was significantly less frequent in SiPAP versus NIV-NAVA (0.0% vs. 9.0%, p < 0.001). No significant difference was observed for premature cycling and late cycling. Peak Edi and swing Edi were significantly lower in NIV-NAVA as compared to SiPAP (7.7 [6.1-9.9] vs. 11.0 [6.7-14.5] μV, p = 0.006; 5.4 [4.2-7.6] vs. 7.6 [4.3-10.8] μV, p = 0.007, respectively). No significant difference was observed between NIV-NAVA and SiPAP for heart rate, respiratory rate, COMFORTneo scores, apnoea, desaturations, or bradycardias. Discussion/conclusion: NIV-NAVA markedly improves patient-ventilator synchrony as compared to SiPAP in extremely premature infants.
... The COMFORTneo score (Supplement 1) ranges from 6 to 30 and has been validated for assessment of prolonged pain in preterm neonates. 28 The COMFORTneo score has a good interrater reliability among trained nurses. 28 A COMFORTneo score of 14 or higher indicates pain and a COMFORTneo score of 8 or lower indicates possible analgesic overtreatment. ...
... 28 The COMFORTneo score has a good interrater reliability among trained nurses. 28 A COMFORTneo score of 14 or higher indicates pain and a COMFORTneo score of 8 or lower indicates possible analgesic overtreatment. The NRS pain and NRS distress scores range from 0 to 10 (0 = no pain/distress, 10 = worst imaginable pain/distress) and represent a nurse's subjective estimate of the patient's pain and distress. ...
... Another limitation of our study is that the COMFORTneo score has been validated in preterm infants, but not specifically in NEC patients. 28 Unfortunately, other scores for assessing prolonged pain, such as the EDIN scale (Échelle Douleur Inconfort Nouveau-Né) and the N-PASS scale (Neonatal Pain, Agitation and Sedation Scale), have not been validated specifically in NEC patients either. 31,32 The validation studies of the COMFORTneo, EDIN, and N-PASS score all included too few NEC patients to assess validity in this group specifically. ...
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Background Adequate pain management for preterm born neonates suffering from the extremely painful disease necrotizing enterocolitis (NEC) is essential, since neonatal exposure to pain is related to negative short-term and long-term consequences. The aim of this study was to describe the current pain management and its effectiveness in NEC patients. Methods In this single-center, retrospective study, neonates (gestational age < 32 weeks and/or birth weight < 1500 g) with NEC Bell’s stage II or III were included. Information on pain (based on COMFORTneo and NRS scores) and analgesic therapy was collected and analyzed for the acute disease period. Results Of 79 patients included, 74 (94%) received intravenous analgesic therapy: most commonly morphine, fentanyl, and acetaminophen. The median COMFORTneo score was 11 (IQR 10–11), however, 49 patients had at least one COMFORTneo score ≥ 14 indicating pain. Nineteen patients had persistent high pain scores ≥ 14 with a median duration of 7.2 h (IQR 2.8–14.0). Conclusions This study showed that despite analgesic therapy, most NEC patients showed signs of pain, and in some, pain persisted for several hours. It suggests that current analgesic therapy frequently failed to prevent pain and existing pain was often insufficiently treated. This supports the urgent need for individualized pain management guidelines for NEC patients. Impact This study is unique in reporting on pain management in neonates suffering from necrotizing enterocolitis (NEC) during the full acute disease period. Despite analgesic therapy, the majority of NEC patients experience pain, and in some patients, pain persists for several hours. These findings highlight the need for improvement of neonatal pain management in NEC patients, including better pain monitoring and guidelines for individualized analgesic therapy. Improved pain management guidelines may help to prevent short-term and long-term consequences of neonatal exposure to pain, as well as excessive exposure to opioids.
... The COMFORTneo scale was chosen because it is validated to assess prolonged pain and stress. 16,17 It is an unidimensional tool successfully implemented in all Danish NICUs. 18,19 The COMFORTneo scale is a modified version of the COMFORT scale and is eligible for use in infants from 23 weeks of GA to one month postnatal age. ...
... Score values below 9 in sedated infants indicate oversedation. 16 The COMFORTneo scale includes the Numeric Rating Scale (NRS) to distinguish between pain and stress (NRS pain and NRS stress). 16 The NRS assessment is based on the nurses' evaluation and knowledge of GA, current treatment, and severity of illness. ...
... 16 The COMFORTneo scale includes the Numeric Rating Scale (NRS) to distinguish between pain and stress (NRS pain and NRS stress). 16 The NRS assessment is based on the nurses' evaluation and knowledge of GA, current treatment, and severity of illness. NRS is performed on a scale ranging from 0 to 10, with 0 to 3 indicating no pain or stress, 4 to 6 indicating moderate pain or stress, and 7 to 10 indicating severe pain or stress. ...
Article
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Abstract Preterm birth is a risk factor for early experience of pain. Despite advances in neonatal care, evidence‐based knowledge of the importance of adequate pain management and strong international guidelines for assessment and treatment of neonatal pain, only 10% of sick term and preterm infants were assessed for pain and stress on a daily basis. The aim of this quality improvement (QI) project is evaluation of implemented guidelines for pain assessment and management, and increased parental involvement in a Norwegian single‐family room NICU. Method: The different steps of the project entailed translation of the English version of COMFORTneo, development and implementation of guidelines with flowcharts for pain management, and pain assessment certification of the interprofessional staff. Part two of the project is supervision of the interprofessional staff in parental involvement in stress‐ and painful procedures. Our study showed that one year after implementation, 88.8% of the COMFORTneo assessments were performed according to the pain management guidelines. The staff used the flowcharts to assess, treat and reassess pain and stress. There was a high interrater reliability with linearly weighted Cohen's kappa values ranging from 0.81 to 0.95, with a median of 0.90. In addition, our study showed increased parental involvement in procedures, from 50.3% before to 82.3% after the quality improvement project. The success of this quality improvement project is explained by systematic use of flowcharts and implemented guidelines for pain management, interprofessional collaboration, and cultural change agents. Theoretical lectures and practical bedside supervision to interprofessional staff increased parental involvement in stress‐ and painful procedures.
... 71 Meanwhile, there are several scales validated for children who are aged between 0 and 5 years 47 (eg, COMFORTneo). 64 In the context of the biopsychosocial perspective on pain in the ICD-11, pain should also be assessed as a multidimensional phenomenon in children. 20 Besides pain intensity, children's and their caregivers' perspective on the pain-related disability (eg, Functional Disability Index 72 ; Bath Adolescent Pain Questionnaire for children aged between 11 and 18 years, 19 ) and health-related quality of life (eg, Paediatric Quality of Life Inventory, 67 ) should be considered. ...
Article
The upcoming 11th revision of the International Classification of Diseases (ICD-11) will include a comprehensive classification of chronic pain for the first time, which is based on the biopsychosocial definition of chronic pain. This presents a great opportunity for pain research and clinical practice. The new classification consists of seven main diagnostic categories of chronic pain, which are further divided into increasingly specific levels of diagnoses. Each diagnosis is characterized by clearly defined operationalized criteria. Future users will need to familiarize themselves with the new system and its application. The aim of the present publication is to provide users of the ICD-11 chronic pain classification with answers to frequently asked questions regarding the ICD-11 as a whole, the ICD-11 chronic pain classification, and its application to common pain syndromes. The questions compiled here reached the International Association for the Study of Pain Task Force via different routes (e.g., at conferences, by letter, or during field testing). Furthermore, the authors collected questions posted to the ICD-11 browser and contacted early users of the classification to enquire about their most frequent difficulties when applying the new diagnoses. The authors of the present publication prepared answers to these frequently asked questions. This publication intends to act as a guide for the future users of the new ICD-11 chronic pain classification, hence facilitating its implementation.
... This is in line with findings from Krekels et al, who showed that the need for rescue morphine was indeed lower in younger children (<10 days) compared with older children (10-365 days), despite using the PK model-based starting dosing regimen for morphine to give a similar morphine exposure for both age groups. These lower COMFORT-B scores and reduced morphine requirements during the first 10 days of life might be explained as a difference in development between the younger and older children, as older children are more likely to express behavioral responses to noxious stimuli, [29][30][31] and are more aware of their environment with increasing age, which could increase the level of distress experienced in the pediatric intensive care unit. 20 Although one might expect that age also affects the response to morphine, we did not identify any association between age and the parameters that characterize the effect of morphine in the model (E 40 , sensitivity parameter for the effect of morphine in the truncated E max model, Hill factor, or probability of being a nonresponder to morphine up-titration). ...
Article
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While the pharmacokinetics (PK) of morphine in children have been studied extensively, little is known about the pharmacodynamics (PD) of morphine in this population. Here, we quantified the concentration‐effect relationship of morphine for postoperative pain in preverbal children between 0 and 3 years of age. For this, we applied Item Response Theory modelling in the PKPD analysis of COMFORT‐behavior (COMFORT‐B) scale data from two previous clinical studies. In the model, we identified a sigmoid Emax model for the effect of morphine and found that in 26% of children increasing morphine concentrations were not associated with lower pain scores (non‐responders to morphine uptitration). In responders to morphine uptitration, the COMFORT‐B score slowly decreases with increasing morphine concentrations at morphine concentrations above 20 ng/ml. In non‐responding children no decrease in COMFORT‐B score is expected. In general, lower baseline COMFORT‐B scores (2.1 points on average) in younger children (postnatal age < 10.3 days) were found. Based on the model, we conclude that the percentage of children at a desirable COMFORT‐B score is maximized at a morphine concentration between 5–30 ng/ml for children younger than 10 days, and between 5–40 ng/ml for children older than 10 days. These findings support a dosing regimen previously suggested by Krekels et al., which would put more than 95% of patients within this morphine target concentration range at steady‐state. Our modelling approach provides a promising platform for pharmacodynamic research of analgesics and sedatives in children. This article is protected by copyright. All rights reserved