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- Anand, K J S, et al.
(author)
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Effects of morphine analgesia in ventilated preterm neonates : primary outcomes from the NEOPAIN randomised trial
- 2004
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In: The Lancet. - 0140-6736 .- 1474-547X. ; 363:9422, s. 1673-82
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Journal article (peer-reviewed)abstract
- BACKGROUND: Opioid analgesia is commonly used during neonatal intensive care. We undertook the Neurologic Outcomes and Pre-emptive Analgesia in Neonates (NEOPAIN) trial to investigate whether pre-emptive morphine analgesia decreases the rate of a composite primary outcome of neonatal death, severe intraventricular haemorrhage (IVH), and periventricular leucomalacia (PVL) in preterm neonates.METHODS: Ventilated preterm neonates (n=898) from 16 centres were randomly assigned masked placebo (n=449) or morphine (n=449) infusions. After a loading dose (100 microg/kg), morphine infusions (23-26 weeks of gestation 10 microg kg(-1) h(-1); 27-29 weeks 20 microg kg(-1) h(-1); 30-32 weeks 30 microg kg(-1) h(-1)) were continued as long as clinically justified (maximum 14 days). Open-label morphine could be given on clinical judgment (placebo group 242/443 [54.6%], morphine group 202/446 [45.3%]). Analyses were by intention to treat.FINDINGS: Baseline variables were similar in the randomised groups. The placebo and morphine groups had similar rates of the composite outcome (105/408 [26%] vs 115/419 [27%]), neonatal death (47/449 [11%] vs 58/449 [13%]), severe IVH (46/429 [11%] vs 55/411 [13%]), and PVL (34/367 [9%] vs 27/367 [7%]). For neonates who were not given open-label morphine, rates of the composite outcome (53/225 [24%] vs 27/179 [15%], p=0.0338) and severe IVH (19/219 [9%] vs 6/189 [3%], p=0.0209) were higher in the morphine group than the placebo group. Placebo-group neonates receiving open-label morphine had worse rates of the composite outcome than those not receiving open-label morphine (78/228 [34%] vs 27/179 [15%], p<0.0001). Morphine-group neonates receiving open-label morphine were more likely to develop severe IVH (36/190 [19%] vs 19/219 [9%], p=0.0024).INTERPRETATION: Pre-emptive morphine infusions did not reduce the frequency of severe IVH, PVL, or death in ventilated preterm neonates, but intermittent boluses of open-label morphine were associated with an increased rate of the composite outcome. The morphine doses used in this study decrease clinical signs of pain but can cause significant adverse effects in ventilated preterm neonates.
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- Bergqvist, L., et al.
(author)
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Seeing through the blind! : ability of hospital staff to differentiate morphine from placebo, in neonates at a placebo controlled trial
- 2007
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In: Acta Paediatrica. - : Wiley. - 0803-5253 .- 1651-2227. ; 96:7, s. 1004-1007
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Journal article (peer-reviewed)abstract
- AIM: To investigate whether professional training and/or clinical experience affect the ability of caregiver to assess clinical signs of pre-emptive morphine analgesia. METHODS: In the Neurological Outcomes & Pre-emptive Analgesia In Neonates trial preterm infants undergoing mechanical ventilation were randomized to receive continuous infusion, either of morphine or placebo blinded. Staff from centres in Sweden (Stockholm and Orebro) completed an assessment form. RESULTS: A total of 360 assessment forms were collected from 52 neonates. In 59% of the cases, caregivers correctly identified patients group. Comparable proportion of answers were correct between physicians, nurses and assistant nurses (63, 60 and 54%, respectively, p = 0.60). Staff with Neonatal intensive care unit experience <1 year identified 63%, as compared to 65% for working 1-5 year, and 55% that has been working >5 years (p = 0.28). Staff's ability to correctly identify group assignment was reduced by amount of additional morphine (p < 0.01) and severity of illness (p = 0.01). CONCLUSIONS: Clinical medical staffs, including neonatologists, have great difficulties in assessing the presence and severity of pain. Further studies should focus on the methods for assessment of prolonged pain in preterm neonates, define the effects of adequate analgesia, and investigate the clinical factors that may alter neonatal responses to acute and prolonged pain.
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- Carbajal, Ricardo, et al.
(author)
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Pain Assessment In Ventilated And Non-ventilated Neonates In Nicus Across Europe : European Pain Audit In Neonates (europain Survey)
- 2014
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In: Archives of Disease in Childhood. - London, United Kingdom : BMJ Publishing Group Ltd. - 0003-9888 .- 1468-2044. ; 99, s. A68-A68
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Journal article (peer-reviewed)abstract
- Background: Neonates undergo many painful procedures during their NICU stay. These may include tracheal intubation/ventilation, skin-breaking procedures, drainage/suctioning of body orifices or cavities. Inherent subjectivity and difficulties of neonatal pain assessment contribute to a wide variety of assessment tools and clinical practices. To date, these practices have been not studied at a large scale.Objective: To determine current clinical practices for neonatal pain assessment in NICUs across Europe.Methods: An epidemiological observational study on bedside pain assessment practices collected data for all neonates in participating NICUs until infants left the unit (discharge, death, transfer to another hospital) or for 28 days. Data collection occurred via an online database for 1 month at each NICU. All neonates up to a gestational age of 44 weeks were included.Results: From October 2012 to June 2013, 243 NICUs from 18 European countries collected pain assessment data in 6680 neonates. Of these, 2142 received tracheal ventilation (TV), 1496 non-invasive ventilation (NIV) and 3042 only spontaneous ventilation (SV). The median (IQR) gestational age of TV, NIV and SV neonates were 32.1 (28.1–37.4), 33.6 (31.0–36.6) and 37.9 (35.0–39.9), respectively (p < 0.001). Overall, 58.5% of TV neonates, 45.0% of NIV neonates and 30.4% of SV neonates received bedside pain assessments (p < 0.001). Fig. shows pain assessments by country.Conclusions: Over half (58.5%) of TV neonates and less than half (45.0%) of NIV neonates had pain assessments performed in European NICUs. Wide variations in the rates of pain assessment exist among countries and an important improvement seems necessary.
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4. |
- Carbajal, Ricardo, et al.
(author)
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Sedation And Analgesia For Neonates In Nicus Across Europe : The Europain Survey
- 2014
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In: Archives of Disease in Childhood. - London, United Kingdom : BMJ Publishing Group Ltd. - 0003-9888 .- 1468-2044. ; 99, s. A64-A64
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Journal article (peer-reviewed)abstract
- Background: Pain and stress induced by mechanical ventilation, invasive procedures, or painful diseases supports the use of sedation/analgesia (S/A) in newborns admitted to Neonatal Intensive Care Units (NICUs). To date, these practices have not been studied at a large scale.Objective: To determine current clinical practices regarding the use of S/A drugs in NICUs across Europe.Methods: This epidemiological observational study on bedside clinical practices regarding S/A collected data for all neonates in participating NICUs until the infant left the unit (discharge, death, transfer) or for up to 28 days. Data collection occurred via an online database for 1 month at each NICU. All neonates up to 44 weeks gestation were included.Results: From October 2012 to June 2013, 243 NICUs from 18 European countries collected data on 6680 eligible neonates. Of these, 2142 received tracheal ventilation (TV), 1496 non-invasive ventilation (NIV) and 3042 only spontaneous ventilation (SV). The median (IQR) gestational age of TV, NIV and SV neonates were 32.1 (28.1–37.4), 33.6 (31.0–36.6) and 37.9 (35.0–39.9), respectively (p < 0.001). Overall, more TV neonates [81.5% (n = 1746)] received S/A drugs than NIV neonates [17.8% (n = 266)] and SV neonates [9.3% (n = 282)]; p < 0.001. Fig. shows the rate of S/A use by country; table shows S/A drugs used.Conclusions: Most ventilated but few non-ventilated neonates (NIV and SV) receive S/A therapy in European NICUs. Wide variations in S/A use, drugs used, and mode of administration (continuous, bolus, or both) exist among countries.
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- Sundell, Isa, et al.
(author)
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National guidelines for neonatal pain management : occurance and content
- 2013
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Conference paper (peer-reviewed)abstract
- Introduction & AimsInternational evidence-based guidelines for preventing or treating neonatal pain were published in 2001(1). They describe sources of acute pain and recommend approaches for pain assessment, and pharmacological and non-pharmacological management. We investigated the occurance and content of national guidelines for neonatal pain management and their compliance with international recommendations. A secondary aim was to study how intubation premedication recommendations were followed in clinical practice.MethodsA questionnaire was distributed to neonatal societies worldwide and to members of the e-mail-lists International Pediatric pain-list, NICU-net and Council of International Neonatal Nurses-network. Additionally a search in Pubmed was done, using pain, neonatal, newborn, guideline, government publication and pain management as searchwords. A web-based survey about premedication prior to intubation of newborn infants was sent to members of the same e-mail-lists.ResultsNational guidelines from 14 countries were obtained, mostly issued by professional societies from 1995 to 2011. Guidelines from 13 countries contained suggestions concerning procedural pain. Other issues were pain assessment (14 countries), postoperative pain (12) and ongoing/prolonged pain (9). Pharmacological and non-pharmacological treatment recommendations were found in 13 national guidelines. Six countries had recommendations for premedication prior to intubation. Seventy-six individuals from 27 different countries responded to the web-based survey. Seventy-one percent used premedications routinely prior to intubation. The most commonly used drug was fentanyl followed by morphine and midazolam. Thirty-four percent reported using muscle relaxant routinely, with suxamethonium as the most commonly used drug. Thirty-six percent used atropine prior to intubation.Discussion & ConclusionsMany countries have still not developed national guidelines for management of neonatal pain. The guidelines obtained in this study comply with the international guidelines concerning their recommendations for pain assessment, actions at procedural pain, and pharmacological and non-pharmacological pain treatment. Many national guidelines do not have specific suggestions concerning dosages of drugs, management of ongoing/prolonged pain, and premedications for intubation. The web-based survey indicates that the use of premedication is still not widely adopted and there is wide variability in the drugs and doses used. The lack of evidence-based recommendations for intubation premedication in many countries also implies that the international guidelines should be revised and updated.Reference1. Anand, K. J. S. & the International Evidence-Based Group for Neonatal Pain (2001). Consensus statement for the prevention and management of pain in the newborn. Archives of Pediatrics and Adolescent Medicine, 155(2), 173-180.The authors have no conflict of interest to declare.
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