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Effect of Benson's relaxation technique versus music intervention on physiological parameters and stress of children with thalassemia during blood transfusions: A randomized controlled trial
Badr, E. A., Ibrahim, H., Saleh, S. E.
Journal of pediatric nursing. 2023
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Editor's Choice
Abstract
BACKGROUND Children with thalassemia are generally dependent on blood transfusions and face a lot of stress and alteration in their physiological parameters through the procedure. AIM: This study aimed to investigate the effect of Benson's relaxation technique versus music intervention on physiological parameters and stress of children with thalassemia during blood transfusions. DESIGN A randomized, controlled trial with three parallel groups. METHODS One hundred and twenty preschool-age children with thalassemia who underwent blood transfusions were randomly assigned to three groups. Children of the control group received only routine hospital care through blood transfusions. Music intervention group children listened to recorded Mozart's music and children of Benson's relaxation group received relaxation intervention before and during the blood transfusions. Outcome measures were physiological parameters and behavioral distress levels. SETTING Hematology outpatient clinic of the Children's University Hospital at El-Shatby in Alexandria from October 2022 to February 2023. RESULTS The mean total score of children's behavioral responses to stress before the blood transfusions procedure was 19.32 ± 4.08, 14.20 ± 0.93, and 16.92 ± 4.74 in the control, music, and Benson groups, respectively. Beyond that, there was a decline in their physiological parameters and behavioral stress response during and after procedure among groups of study (P = 0.005 & <0.001, respectively). CONCLUSION Music and Benson's relaxation interventions had a helpful effect on stabilizing the physiological parameters and reducing behavioral distress levels in children with thalassemia undergoing blood transfusions. PRACTICE IMPLICATIONS This study directs paediatric nurses to apply Benson's relaxation and music interventions for children with thalassemia to enhance their responses.
PICO Summary
Population
Preschool-age children with thalassemia who underwent blood transfusions (n= 120).
Intervention
Benson’s relaxation technique intervention (n= 40).
Comparison
Mozart's music intervention (n= 40); routine hospital care (n= 40).
Outcome
The mean total score of children's behavioral responses to stress before the blood transfusions procedure was 19.32 ± 4.08, 14.20 ± 0.93, and 16.92 ± 4.74 in the control, music, and Benson groups, respectively. Beyond that, there was a decline in their physiological parameters and behavioral stress response during and after procedure among groups of study.
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Trial-related blood sampling and red-blood-cell transfusions in preterm infants
Lewis, A. E., Kappel, S. S., Hussain, S., Sangild, P. T., Zachariassen, G., Aunsholt, L.
Acta paediatrica (Oslo, Norway : 1992). 2023
Abstract
AIM: To determine if trial-related blood sampling increases the risk of later red-blood-cell (RBC) transfusion in very preterm infants, we compared the volume of clinical- and trial-related blood samples, in a specific trial and correlated to subsequent RBC transfusion. METHODS For 193 very preterm infants, participating in the FortiColos trial (NCT03537365), trial-related blood volume drawn was in accordance to ethical considerations established by the European Commission. Medical records were reviewed to assess the number and cumulated volume (mL/kg) of blood samples (both clinical- and trial-related). Data were compared with need of RBC transfusions during the first 28days of life. RESULTS Mean (SD) gestational age and bith weight was 28 ± 1 weeks and 1168 ± 301 g. In total, 11% of total blood volume was drawn for sampling (8.1 ± 5.1 mL/kg) and trial-related sampling accounted for 1.6 ± 0.6 mL/kg. Trial-related blood sampling had no impact on RBC transfusion (p=0.9). CONCLUSION Clinical blood sampling in very preterm infants is associated with blood loss and subsequent need for RBC transfusions. In a specific trial requiring blood samples, we found no additional burden of trial-related blood sampling. The study suggest that trial-related sampling is safe if European criteria are followed.
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Rotational thromboelastometry guided blood component use in cirrhotic children undergoing invasive procedures: Randomized Controlled Trial
Maria A, Lal BB, Khanna R, Sood V, Mukund A, Bajpai M, Alam S
Liver international : official journal of the International Association for the Study of the Liver. 2022
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Editor's Choice
Abstract
BACKGROUND & AIMS This randomized controlled trial (RCT) was conducted with the aim to evaluate the efficacy and safety of using ROTEM-based transfusion strategy in cirrhotic children undergoing invasive procedures. METHODS This was a open-label, RCT which included (i) children under 18 years of age with liver cirrhosis; (ii) INR between 1.5 and 2.5; and/or (iii) platelet count between 20x10(9) /L to 50x10(9) /L (for procedures other than liver biopsy) and between 40x10(9) /L to 60x10(9) /L (for liver biopsy); and (iv) listed for invasive procedures. Stratified randomization was done for children undergoing liver biopsies. Patients randomized to the ROTEM and conventional groups received blood component transfusion using predefined criteria. RESULTS A total of 423 invasive procedures were screened for inclusion of which 60 were randomized (30 in each group with comparable baseline parameters). The volume of total blood components, fresh frozen plasma (FFP) and platelets transfused was significantly lower in ROTEM as compared to conventional group. Only 46.7% of children in ROTEM group received a blood component compared to 100% in conventional group (p<0.001). The requirement of FFP (ROTEM 43.3%, Conventional: 83.3%, p = 0.001) was significantly lower in the patients receiving ROTEM guided transfusions. There was no difference in procedure related bleed and transfusion related complications between the 2 groups. ROTEM was cost effective (p=0.002) despite the additional cost of the test. CONCLUSION ROTEM-based transfusion strategies result in lower blood component transfusion in cirrhotic children undergoing invasive procedures without an increase in risk of procedure-related bleed. ROTEM-guided transfusion strategy is cost-effective.
PICO Summary
Population
Children with liver cirrhosis undergoing invasive procedures (n= 60).
Intervention
ROTEM-based transfusion strategy (n= 30).
Comparison
Conventional coagulation tests-based transfusion strategy (n= 30).
Outcome
The volume of total blood components, fresh frozen plasma (FFP) and platelets transfused was significantly lower in ROTEM as compared to conventional group. Only 46.7% of children in ROTEM group received a blood component compared to 100% in conventional group. The requirement of FFP (ROTEM: 43.3%, conventional: 83.3%) was significantly lower in the patients receiving ROTEM guided transfusions. There was no difference in procedure related bleed and transfusion related complications between the two groups. ROTEM was cost-effective despite the additional cost of the test.
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Comparison between intraoperative bleeding score and ROTEM® measurements to assess coagulopathy during major pediatric surgery
Restin T, Schmugge M, Cushing MM, Haas T
Transfusion and apheresis science : official journal of the World Apheresis Association : official journal of the European Society for Haemapheresis. 2021;:103191
Abstract
PURPOSE Intraoperative bleeding should be regularly assessed visually to guide coagulation management. Whereas viscoelastic testing with ROTEM® measurement has been proven to be useful in detecting coagulopathies, the visual assessment is not standardized. This study therefore aims to compare a standardized visual assessment with ROTEM® results. METHODS A 5-point bleeding score was created and applied in a recently published randomized controlled trial in major pediatric non-cardiac surgery. This score assesses overall bleeding tendency and the occurrence of diffuse bleeding, aqueous bleeding, bleeding outside the operative field, and the ability to control bleeding. Validity of this score was tested by post hoc comparison to the results of simultaneously performed ROTEM® measurements. RESULTS Signs of coagulopathic bleeding were assessed at 183 time points. Mild to moderate bleeding intensity was judged at 103 time points, in 42 % abnormal ROTEM® traces were obtained simultaneously. When severe bleeding was scored, abnormal ROTEM values occurred in 58 %, and FIBTEM-values were significantly lower than in the "no bleeding group". Altogether, the correlation between bleeding score and ROTEM® measurements was not significant. CONCLUSIONS The standardized visual assessment did not correlate well with ROTEM® measurements, suggesting that it is not useful to detect coagulopathy. Trial registry number: ClinicalTrials.gov identifier No. NCT01487837.
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Use of electronic self-administered bleeding assessment tool in diagnosis of paediatric bleeding disorders
Kaur D, Kerlin BA, Stanek JR, O'Brien SH
Haemophilia : the official journal of the World Federation of Hemophilia. 2021
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Free full text
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Editor's Choice
Abstract
INTRODUCTION In the era of electronic medical records, pen-and-paper-based physician-administered bleeding assessment tools (BAT) remain under-utilized in the clinical setting, as they are noted to be time-consuming. AIM: The current study reviews the use of an electronic self-administered bleeding assessment tool (eBAT) prospectively in a paediatric haematology clinic and in comparison with a physician administered BAT (pBAT). MATERIALS AND METHODS This was reviewed and approved in the current form because the aims statement includes the method regarding comparison of 2 groups. So no additional section required. RESULTS A total of 94 BAT response pairs were available for analysis. The median time required for patients or parents to complete the eBAT was 8 min, with less than a third of the patients requiring over 10 min. The median bleeding scores noted in this study were 4 for both the BATs, with strong positive correlation between the eBAT and the physician administered bleeding questionnaire. The eBAT had a sensitivity of 93.8% (95% CI 82.8%-98.7%), a specificity of 34.8% (95% CI 21.4%-50.3%), a positive predictive value (PV) of 60.0% (95% CI 54.5%-65.2%) and a negative PV of 84.2% (95% CI 62.5%-94.5%) for identifying a bleeding disorder. CONCLUSIONS Findings indicate that eBAT is a valid and time-efficient screening tool for evaluating patients' bleeding symptoms, which can improve clinical applicability of BATs by reducing time for bleeding history review.
PICO Summary
Population
Paediatric haematology patients (n=94).
Intervention
Electronic self-administered bleeding assessment tool (eBAT), (n= 94).
Comparison
Physician administered BAT (pBAT), (n= 94).
Outcome
The median time required for patients or parents to complete the eBAT was 8 min, with less than a third of the patients requiring over 10 min. The median bleeding scores noted in this study were 4 for both the BATs, with strong positive correlation between the eBAT and the physician administered bleeding questionnaire. The eBAT had a sensitivity of 93.8%, a specificity of 34.8%, a positive predictive value (PV) of 60.0%, and a negative PV of 84.2% for identifying a bleeding disorder.
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Combined Use of Rotational Thromboelastometry (Rotem) and Platelet Impedance Aggregometry (Multiplate Analyzer) in Cyanotic and Acyanotic Infants and Children Undergoing Cardiac Surgery With Cardiopulmonary Bypass: Subgroup Analysis of a Randomized Clinical Trial
Dieu, A., Van Regemorter, V., Detaille, T., Houtekie, L., Eeckhoudt, S., Khalifa, C., Kahn, D., Clement De Clety, S., Poncelet, A., Momeni, M.
Journal of Cardiothoracic and Vascular Anesthesia. 2021;35(7):2115-2123
Abstract
OBJECTIVES Few studies have investigated the Multiplate platelet function analyzer in pediatrics. The authors evaluated Multiplate combined with Rotem in terms of guiding platelet transfusion after pediatric cardiac surgery with cardiopulmonary bypass (CPB). The authors further compared coagulation parameters between cyanotic and acyanotic patients. DESIGN Subgroup analysis of a randomized clinical trial. SETTING Tertiary hospital. PARTICIPANTS Patients weighing between seven and 15 kg. INTERVENTIONS None. MEASUREMENTS AND MAIN RESULTS Rotem and Multiplate tests were performed (1) after anesthesia induction, (2) upon CPB separation, and (3) upon intensive care unit arrival. Among a total of 59 subjects, 9 patients required platelet transfusion. In multivariate linear regression, analysis EXTEM maximum clot firmness upon CPB separation was associated with the volume of transfused platelets (regression coefficient = -0.348 [95% confidence interval -1.006 to -0.028]; p = 0.039). No such association was found for the Multiplate test. Acyanotic and cyanotic heart disease were present in 32 and 27 children, respectively. There were no significant differences between these two groups in terms of platelet count and function. Postoperative blood loss was significantly higher in the cyanotic group compared with the acyanotic arm (p = 0.015; difference [95% confidence interval -2.40 {-4.20 to -0.60}]). There were no differences between groups regarding transfusion of allogeneic blood products. CONCLUSIONS This study showed that Rotem, but not Multiplate results, were associated with platelet transfusion in pediatric cardiac surgery with no intake of platelet inhibitors. The usefulness of combining these tests in platelet transfusion decision-making needs to be evaluated in larger populations.
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Outcome of Early Hemostatic Intervention in Children With Sepsis and Nonovert Disseminated Intravascular Coagulation Admitted to PICU: A Randomized Controlled Trial
El-Nawawy AA, Elshinawy MI, Khater DM, Moustafa AA, Hassanein NM, Wali YA, Nazir HF
Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies. 2020
Abstract
Critically ill children with sepsis may develop catastrophic thrombotic and hemorrhagic syndrome of disseminated intravascular coagulopathy as a final common pathway. OBJECTIVES Evaluation of the outcome of early hemostatic management of disseminated intravascular coagulopathy in patients with severe sepsis/septic shock admitted to PICU, before the development of clinically overt disseminated intravascular coagulopathy. DESIGN Prospective interventional, open label randomized controlled clinical trial. SETTING PICU at Alexandria University Children's Hospital. PATIENTS The study included 80 patients with proven severe sepsis/septic shock in nonovert disseminated intravascular coagulopathy stage. They were randomly assigned into two groups (group 1 and group 2). INTERVENTIONS Specific intervention was applied for group 1 (plasma transfusion, low-dose unfractionated heparin, and tranexamic acid). MEASUREMENTS All patients had assessment of Pediatric Index of Mortality 2 score, Pediatric Logistic Organ Dysfunction score, inotropic score, routine laboratory, and hemostatic tests including fibrin degradation products and D-dimers. Disseminated intravascular coagulopathy risk assessment scores were calculated on daily basis. RESULTS Mortality rate was significantly higher in group 2. Progression to overt disseminated intravascular coagulopathy was significantly more common among group 2 patients than group 1 (45% and 10%, respectively) (p < 0.0001). Disseminated intravascular coagulopathyRisk Assessment Scores were significantly higher on the second and fifth days among group 2 patients. The initial specific hemostatic intervention was the only significant predictor of survival and prevention of progression to overt disseminated intravascular coagulopathy. CONCLUSIONS Our results suggest that early use of a combination of fresh frozen plasma transfusion, low-dose heparin, and tranexamic acid in children with severe sepsis/septic shock in the "window of opportunity" before the development of overt disseminated intravascular coagulopathy stage was associated with better outcome for survival and prevention of progression to overt disseminated intravascular coagulopathy, with no increase in bleeding risk. Larger multicenter studies are needed to further prove this practice.
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Efficacy and toxicities of low-temperature plasma radiofrequency ablation for the treatment of laryngomalacia in neonates and infants: a prospective randomized controlled trial
Xu H, Chen F, Zheng Y, Li X
Annals of translational medicine. 2020;8(21):1366
Abstract
BACKGROUND Laryngomalacia is the most common cause of stridor in neonates and infants, and supraglottoplasty is the mainstay of surgical treatment. Although low-temperature plasma radiofrequency ablation (LTP-RFA) using coblation technology has been used for treating laryngomalacia, it is still lack of high-quality clinical evidence. Therefore, we conduct this prospective randomized study to clearly define the role of LTP-RFA for the treatment of laryngomalacia in neonates and infants. METHODS Between Jan 2017 and Dec 2019, a total of 89 children with laryngomalacia were included for analysis. All patients were initially stratified according to the severity of laryngomalacia. Patients with severe laryngomalacia were randomly assigned to receive LTP-RFA or traditionally surgical supraglottoplasty, while patients with moderate laryngomalacia were assigned to LTP-RFA or observation. The primary end point was the efficacy and toxicities of LTP-RFA by assessing the changes of clinical score and visual analogue scale (VAS) symptom score. The total score was the combination of clinical score with VAS score. RESULTS Of the 89 children, 40 children presented with severe laryngomalacia, and the remaining 49 children were diagnosed as moderate laryngomalacia. The median age was 68 days (range, 19 to 337 days). For children with severe laryngomalacia, our results showed that LTP-RFA treatment significantly reduced the operative time (5.55±1.66 vs. 18.7±5.31 min, P<0.001), length of hospital stay (6.71±1.15 vs. 7.95±1.55 days, P=0.008) and the amount of intraoperative hemorrhage (1.71±1.79 vs. 4.90±1.82, P<0.001) when compared to traditionally surgical supraglottoplasty, while the treatment efficacy was comparable between LTP-RFA and traditionally surgical supraglottoplasty in terms of changed total score (P=0.322), changed clinical score (P=0.135) and changed VAS symptom score (P=0.559). Additionally, for children with moderate laryngomalacia, LTP-RFA treatment significantly improved the symptom evaluated by total score (P<0.001), clinical score (P<0.001) and VAS symptom score (P<0.001) in comparison with the observation group. Post-operative pneumonia was observed in 10 patients. No surgical related death was reported. CONCLUSIONS The present study indicated that LTP-RFA was an effective treatment option for both severe and moderate laryngomalacia in neonates and infants with a low intraoperative complication. Long-term outcomes of LTP-RFA for laryngomalacia would be reported in further studies.
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Effect of Umbilical Cord Blood Sampling versus Admission Blood Sampling on Requirement of Blood Transfusion in Extremely Preterm Infants: A Randomized Controlled Trial
Balasubramanian H, Malpani P, Sindhur M, Kabra NS, Ahmed J, Srinivasan L
The Journal of pediatrics. 2019
Abstract
OBJECTIVE To evaluate the effect of blood sampling from the placental end of the umbilical cord compared with initial blood sampling from neonates, on the need for first packed red blood cell transfusion in extremely preterm infants. We hypothesized that cord blood sampling could delay the time to first blood transfusion. STUDY DESIGN In this single-center, assessor blind, randomized controlled trial, we included extremely low birth weight neonates <28 weeks of gestational age at birth. Five milliliter of blood for initial laboratory investigations was collected either from the placental end of the umbilical cord (study group) or from the neonate upon neonatal intensive care unit admission (control group). Both groups received similar anemia prevention strategies. The primary outcome was the time (in days) to the first packed red blood cell transfusion, and was compared using survival analysis. RESULTS Eighty neonates were enrolled. The time to first transfusion was significantly delayed in the cord sampling group (30 vs 14 days, hazard ratio: 0.44, [95% CI 0.27-0.72], P < .001). Fewer neonates in the cord sampling group were transfused in the first 28 days of life (30% vs 75%, P < .001). Overall transfusion requirements and other clinical outcomes were similar in the groups. CONCLUSIONS Initial blood sampling from placental end of umbilical cord, when combined with anemia prevention strategies, significantly prolonged the time to first transfusion and reduced the need for early transfusions among extremely premature neonates. TRIAL REGISTRATION Ctri.nic.in/ (CTRI/2017/04/008320).
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Volume Versus Mass Dosing of Epinephrine for Neonatal Resuscitation: A Randomized Trial
Brune KD, Bhatt-Mehta V, Rooney DM, Weiner GM
Hospital pediatrics. 2019;9(10):757-762
Abstract
BACKGROUND Intravenous epinephrine for neonatal resuscitation requires weight-based calculations. Epinephrine is available in 2 different concentrations, increasing the risk of dosing errors. Expert panels have conflicting recommendations for the ordering method. The Neonatal Resuscitation Program recommends the volume (milliliters per kilogram) method, whereas the Institute for Safe Medication Practices recommends the mass (milligrams per kilogram) method. In this study, we aim to determine if the mass method is more accurate and efficient than the volume method. METHODS In a randomized crossover simulation study, 70 NICU and pediatric emergency department nurses calculated the intended dose then prepared epinephrine using both the mass and volume methods. Both epinephrine concentrations were available. Scenarios were video recorded and timed. The primary outcome was the proportion of epinephrine doses prepared correctly. Variables associated with correct dosing were analyzed by using logistic regression. RESULTS Of 136 total doses, 77 (57%) were prepared correctly. The correct intended dose was calculated more frequently by using the mass method (82% vs 68%; risk difference 15%; 95% confidence interval 3% to 26%), but there was no difference in the proportion of doses that were actually prepared correctly (53% of mass method doses versus 60% of volume method doses; risk difference -7%; 95% confidence interval -24% to 9%). There was no difference between methods in the time required to prepare the dose. Selecting the correct epinephrine concentration was the only variable associated with correct dosing. CONCLUSIONS The mass method was neither more accurate nor more efficient. Nurses made frequent errors when using both methods. This is a serious patient safety risk. Additional educational and medication safety interventions are urgently needed.