Adverse Events In Pediatric Patients Research Articles

Efficacy of prophylactic dexmedetomidine in preventing postoperative junctional ectopic tachycardia in pediatric cardiac surgery patients: A systematic review and meta-analysis.

Junctional ectopic tachycardia is a serious tachyarrhythmic complication following pediatric cardiac surgery. It is difficult to manage and is associated with significant morbidity and mortality. Conventional nonpharmacological and pharmacological measures have shown limited effects. Dexmedetomidine is an α2 agonist which has recently been shown in multiple studies to be effective. The aim of this systematic review with meta-analysis was to evaluate the efficacy of prophylactic dexmedetomidine administration in the prevention of junctional ectopic tachycardia in pediatric patients following cardiac surgeries. We searched MEDLINE, EMBASE, Cochrane, Web of Science, and relevant references published in English before December 20, 2017 and performed meta-analysis on the selected studies, with one group receiving prophylactic perioperative dexmedetomidine administration and another group receiving placebo. The primary outcome was the incidence of junctional ectopic tachycardia, secondary outcomes included bradycardia, hypotension, intensive care unit stay, total hospital stay, inotropic scores, and total mechanical ventilation time. Odds ratio or mean difference with 95% confidence intervals were calculated using a random effect model. Seven studies (5 prospective randomized studies and 2 retrospective case-controlled studies) with a total of 1616 patients were analyzed. The incidence of junctional ectopic tachycardia in the dexmedetomidine group was significantly reduced compared to placebo. Similarly, intensive care unit stay, inotropic scores, and total mechanical ventilation time were also significantly decreased in the dexmedetomidine group. No significant increases in adverse events were found. Mortality was low in both groups. Prophylactic dexmedetomidine is effective in reducing the incidence of postoperative junctional ectopic tachycardia without significant increases in adverse events in pediatric patients undergoing surgery for congenital heart diseases.

Atropine therapy versus no atropine therapy for the prevention of adverse events in paediatric patients undergoing intubation

Atropine therapy versus no atropine therapy for the prevention of adverse events in paediatric patients undergoing intubation

Relationship between dose of antithyroid drugs and adverse events in pediatric patients with Graves' disease.

.Graves’ disease (GD) accounts for a large proportion of pediatric hyperthyroidism, and the first-line treatment is antithyroid drug (ATD) therapy. Methimazole (MMI) is effective in most patients but is associated with significant adverse events (AEs). We reviewed the medical records of GD patients (n = 56) with onset age of <15 yr and investigated the relationship between MMI dose and AEs. The study population comprised 11 male and 45 female patients and the median age at diagnosis was 11 yr. All patients were initially treated with ATDs. Among the 52 patients initially treated with MMI, 20 received a low dose, and 32 received a high dose of MMI (< 0.7 vs ≥ 0.7 mg/kg/day, respectively). AEs occurred in 20% of the patients in the low-dose MMI group, and in 50% patients in the high-dose MMI group (p = 0.031). A greater variety of AEs was observed in the high-dose group. Neutropenia and rash were observed in both groups. With treatment transition to low-dose MMI according to the Japanese Society for Pediatric Endocrinology guidelines, we expect a decrease in the incidence of AEs in future. However, we should be careful as neutropenia and rash can occur independently of the MMI dose.

Adverse events in paediatric patients taken to magnetic resonance imaging under sedation or anaesthesia☆

Introduction: Nuclear magnetic resonance is a technique requiring breath holding or staying still for long periods of time for image acquisition. For this reason, paediatric patients need to be given sedation or anaesthesia, creating additional risks to those found in other areas. Objective: To describe the incidence of adverse events in paediatric patients in the magnetic resonance service with the presence of an anaesthetist. Materials and methods: Descriptive observational study to assess the incidence of adverse events in 4786 patients under 15 years of age taken to magnetic resonance imaging with an attending anaesthetist for sedation or anaesthesia at Instituto de Alta Tecnología Médica between 2010 and 2014. Results: There were 12 adverse events with a rate of 2.5 for every 1000 paediatric patients. Of these, there were 6 serious, 4 moderate and 2 mild adverse events. The proportion of mortality was 0.04%. Conclusion: Performing magnetic resonance imaging studies under sedation or anaesthesia given by an anaesthetist in patients under 15 years of age is safe. However a risk-benefit analysis is required in hospitalized or decompensated patients, in order to assess the best option. Introducción: La resonancia magnética es una técnica donde se requieren apneas o periodos de inmovilidad considerables para la adquisición de imágenes. Inmovilidad que por condiciones de los pacientes pediátricos son difíciles mantener, requiriendo administración de sedación o anestesia generando riesgos adicionales a los existentes en otras áreas. Objetivo: Describir la incidencia de eventos adversos en pacientes pediátricos en el servicio de resonancia magnética bajo asistencia por anestesiólogo. Materiales y métodos: Estudio observacional descriptivo, donde se valoró la incidencia de eventos adversos en 4786 pacientes menores de 15 años que fueron llevados a resonancia bajo asistencia por anestesiólogo para sedación o anestesia en el Instituto de Alta Tecnología Médica entre los años 2010–2014. Resultados: Se presentaron 12 eventos adversos, con un índice de 2.5 por cada 1000 pacientes pediátricos, de los cuales 6 eventos adversos fueron graves, 4 moderados y 2 leves. La proporción de mortalidad fue del 0.04%. Conclusión: Realizar estudios de resonancia magnética bajo sedación o anestesia por anestesiólogo en pacientes menores de 15 años es seguro, sin embargo en pacientes hospitalizados o descompensados debe hacerse un análisis riesgo - beneficio y valorar la mejor opción.

Adverse events in paediatric patients taken to magnetic resonance imaging under sedation or anaesthesia

Adverse events in paediatric patients taken to magnetic resonance imaging under sedation or anaesthesia

Eventos adversos en pacientes pediátricos sometidos a resonancia magnética bajo sedación o anestesia

IntroductionNuclear magnetic resonance is a technique requiring breath holding or staying still for long periods of time for image acquisition. For this reason, paediatric patients need to be given sedation or anaesthesia, creating additional risks to those found in other areas. ObjectiveTo describe the incidence of adverse events in paediatric patients in the magnetic resonance service with the presence of an anaesthetist. Materials and methodsDescriptive observational study to assess the incidence of adverse events in 4786 patients under 15years of age taken to magnetic resonance imaging with an attending anaesthetist for sedation or anaesthesia at Instituto de Alta Tecnología Médica between 2010 and 2014. ResultsThere were 12 adverse events with a rate of 2.5 for every 1000 paediatric patients. Of these, there were 6 serious, 4 moderate and 2 mild adverse events. The proportion of mortality was 0.04%. ConclusionPerforming magnetic resonance imaging studies under sedation or anaesthesia given by an anaesthetist in patients under 15years of age is safe. However a risk-benefit analysis is required in hospitalized or decompensated patients, in order to assess the best option.

Adverse events in paediatric patients taken to magnetic resonance imaging under sedation or anaesthesia

IntroductionNuclear magnetic resonance is a technique requiring breath holding or staying still for long periods of time for image acquisition. For this reason, paediatric patients need to be given sedation or anaesthesia, creating additional risks to those found in other areas. ObjectiveTo describe the incidence of adverse events in paediatric patients in the magnetic resonance service with the presence of an anaesthetist. Materials and methodsDescriptive observational study to assess the incidence of adverse events in 4786 patients under 15 years of age taken to magnetic resonance imaging with an attending anaesthetist for sedation or anaesthesia at Instituto de Alta Tecnología Médica between 2010 and 2014. ResultsThere were 12 adverse events with a rate of 2.5 for every 1000 paediatric patients. Of these, there were 6 serious, 4 moderate and 2 mild adverse events. The proportion of mortality was 0.04%. ConclusionPerforming magnetic resonance imaging studies under sedation or anaesthesia given by an anaesthetist in patients under 15 years of age is safe. However a risk-benefit analysis is required in hospitalized or decompensated patients, in order to assess the best option.

Prolactin-related adverse events and change in prolactin levels in pediatric patients given antipsychotics for schizophrenia and schizophrenia spectrum disorders: A systematic review.

BackgroundSecond-generation antipsychotics are commonly prescribed for pediatric patients with schizophrenia and schizophrenia spectrum disorders despite their lack of approval for use in children. Although considered a safer alternative to first-generation antipsychotics, there is evidence to suggest that second-generation antipsychotics may be associated with some adverse events as well as an increase in prolactin levels. The purpose of this review is to examine the risk of prolactin-related adverse events in pediatric patients using antipsychotics and to quantify changes in prolactin for this population.MethodsLiterature searches were conducted in Medline, Embase, the Cochrane Central Register of Controlled Trials, and PsycINFO databases, supplemented with review of select gray literature to identify both randomized controlled trials and observational studies on pediatric patients prescribed antipsychotic medications for schizophrenia or schizophrenia spectrum disorders. Using a narrative approach, data on adverse events were recorded and changes from baseline in prolactin were pooled, where possible, from the randomized trials. Change from baseline in prolactin was evaluated for each treatment, as well as in comparison to placebo and to other treatments. Where data was available, these changes were evaluated separately for male and female patients.ResultsSix randomized controlled trials and five observational studies, all examining the effects of second-generation antipsychotics, were selected. Literature reporting the effects of risperidone, quetiapine, aripiprazole, olanzapine, and paliperidone was identified, with varying doses. Prolactin-related adverse events were sparsely reported across studies. In evidence gathered from randomized controlled trials, risperidone, olanzapine, and two doses of paliperidone (3–5 mg/day and 6–12 mg/day) were associated with increased prolactin levels compared to baseline. With the exception of paliperidone, similar trends were observed in males and females, separately. The findings of the observational evidence served to both complement and run contrary to the randomized trials, with discrepancies attributed to differences in patient and treatment characteristics.ConclusionsNo definitive conclusions between second-generation antipsychotic use and prolactin-related adverse events can be made based on the available literature. While some trends in prolactin level changes emerged, this was based on few trials with small sample sizes. Future investigations should emphasize reporting on treatment safety.Trial registrationPROSPERO CRD42014009506.Electronic supplementary materialThe online version of this article (doi:10.1186/s12887-016-0710-y) contains supplementary material, which is available to authorized users.

Adverse Events in Pediatric Patients Receiving Long-term Oral and Intravenous Antibiotics.

Children receiving long-term antibiotic therapy (LTAT) at Children's Hospital Colorado (CHCO) are treated with both oral and intravenous (i.v.) agents and often experience complications not comprehensively described by the literature. We sought to describe adverse drug events (ADEs) and venous access complications (VACs) in pediatric patients managed with oral and i.v. antibiotics so as to inform clinical decision-making, drug monitoring, and patient counseling at CHCO. We conducted a retrospective review of children receiving LTAT through the CHCO infectious disease service from 2006 to 2012. Demographic, microbiologic, diagnostic data, ADEs, and VACs were recorded for each patient. From 2006 to 2012, 521 patients received 1876 courses, accounting for 71,306 days of antimicrobial therapy. A total of 219 patients (42%) developed an ADE with discontinuation of the offending agent in 65% of courses associated with an ADE. The most common ADEs were neutropenia, rash, and diarrhea. Central lines were placed in 376 patients with 106 (28%) experiencing ≥1 VACs. I.v. agents were associated with a fourfold increase in the rate of ADEs compared with oral agents, and a fivefold increase when VACs were included. Practitioners may make more informed decisions and risk assessments by using descriptive ADE information for specific agents and mode of drug delivery to mitigate risk, thereby improving the quality of care. Patients should be counseled regarding risks of LTAT, including increased risk with i.v. therapy, and actively monitored for side effects.

Adverse Events Following Gastrointestinal Endoscopy in Children: Classifications, Characterizations, and Implications.

To conduct a comprehensive study of postendoscopic adverse events (AEs) in children, categorizing them by the level of intervention required. Previous studies of endoscopic AE in children have focused on intraprocedural and short-term outcomes, such as bleeding, perforation, and infection, and may underestimate the incidence of AEs. Prospective observational study tracking AEs in pediatric patients within 72 hours of an endoscopic procedure. Single-center study performed at an academic, tertiary care, free-standing children's hospital over a 48-month period, from July 2010 through June 2014. Of 9577 pediatric endoscopic procedures, cases identified as having an AE during or following endoscopy were subject to additional chart review for abstraction of relevant data. Type, severity, and subsequent interventions of AEs were the primary outcome measures. Events were categorized by severity grade, with grade 1, no intervention; grade 2, outpatient evaluation; grade 3, hospitalization or repeat endoscopy; grade 4, surgery or intensive care unit admission; and grade 5, death. In total, 249 endoscopic AEs were recognized of 9577 procedures performed, yielding a rate of 2.6%. Of these, 160 were identified to result in medical evaluation and costs (≥grade 2) for a rate of 1.7%. Rates of endoscopic AE after advanced or interventional endoscopic procedures were higher, with 65 of 1167 events, resulting in a total AE rate of 5.6% and a rate of 4.4% for AE ≥ grade 2. There were 10 cases of significant bleeding (0.1%), 9 cases of infection (0.09%), and 12 cases of perforation (0.13%), primarily occurring with advanced/interventional procedures. Single-center study, lack of standardized criteria for ED referral. AEs presenting within 72 hours of endoscopy and resulting in medical intervention, occur more commonly than previously recognized in children. Standardized postendoscopy surveillance systems and definitions of AEs are needed.

Issues in Propofol Sedation for Pediatric Patients Using Target Control Infusion (TCI): Safety in Children 1-3 Years Old Versus Children Older than 3 Years of Age

Purpose: Appropriate sedation is required when performing proton radiation therapy on pediatric patients. A target-controlled infusion (TCI) of propofol has recently been used for this purpose. However, there may be safety issues with the use of TCI in pediatric patients, as the initial bolus dose might be excessive for younger patients. To compare the safety and the incidence of adverse events between patients under and over 3 years of age undergoing sedation with a TCI (Paedfusor) model. Methods: We performed a retrospective observational study by analyzing the medical records of patients who underwent a computer tomography simulation prior to beginning proton radiation therapy between January 2013 and December 2014. Patients were divided into those 1-3 years of age and those > 3 years of age. The incidence of adverse events was tabulated. Results: Fifty-two patients-16 patients 1-3 years of age and 40 patients > 3 years of age-were included in the study. The adverse event incidence was the primary outcome. There was no statistically significant difference in desaturation (p = 0.231), nasopharyngeal airway insertion (p = 0.366), bradycardia (p = 1.000), and hypotension (p = 0.578). Additionally, there was no significant difference in sedation time, recovery time, propofol dose, and target concentration for induction or maintenance of anesthesia. Conclusions: The use of propofol TCI for the induction and maintenance of sedation did not show an increased risk of adverse events in pediatric patients 1-3 years of age versus patients > 3 years of age.

Clobazam and Aggression-Related Adverse Events in Pediatric Patients With Lennox–Gastaut Syndrome

BackgroundLennox–Gastaut syndrome is an intractable epileptic encephalopathy marked by frequent drop seizures. Most patients develop moderate intellectual disability and behavioral problems, including hyperactivity, aggressiveness, insecurity, and autistic features. Treatment with benzodiazepines, including clobazam, may increase aggression/behavioral problems in patients with Lennox–Gastaut syndrome. Post hoc analyses of data from the OV-1012 trial assessed the potential for behavioral effects with clobazam treatment in pediatric (2 to 18 years) patients with Lennox–Gastaut syndrome. MethodsOV-1012 was a phase 3, randomized, double-blind, parallel-group trial comprising a 4-week baseline period, 3-week titration period, and a 12-week maintenance period. Data from 194 patients were analyzed for a history of aggression/behavioral problems, occurrence of aggression-related adverse events, and by assessment of potential drug-related effects on four behavior domains of the Child Behavior Checklist. ResultsTwenty-nine aggression-related adverse events were reported for 27 (13.9%) patients. Similar percentages of clobazam-treated patients with and without a history of aggressive behavior experienced an aggression-related adverse event (16.7% versus 15.5%, respectively). In the medium- and high-dosage clobazam groups, onset of aggression-related adverse effects occurred within the 3-week titration period with 63.2% resolving by the end of the study. Aggression-related adverse event onset and resolution were similar for the low-dosage clobazam and placebo groups. Analysis of baseline to postbaseline T scores for the behavior domains of the Child Behavior Checklist indicated no significant differences between clobazam and placebo. ConclusionsPost hoc analyses indicate that the overall rate of aggression with clobazam treatment was low and dosage dependent. Clobazam treatment was effective in reducing drop seizures regardless of aggression experience.

Dermatologic adverse events in pediatric patients receiving targeted anticancer therapies: a pooled analysis.

The dermatologic adverse events (AEs) of various molecularly targeted therapies are well-described in adult cancer patients. Little has been reported on the incidence and clinical presentation of such AEs in pediatric patients with cancer. To address this gap, we analyzed the dermatologic AEs reported across clinical trials of targeted anticancer therapies in pediatric patients. We conducted an electronic literature search (PubMed, American Society of Clinical Oncology annual meetings' abstracts, ClinicalTrials.gov, NCI's Pediatric Oncology Branch webpage) to identify clinical trials involving targeted anticancer therapies that reported dermatologic AEs in their safety data. Studies were limited to the pediatric population, monotherapy trials (oncology), and English language publications. Pooled data from 19 clinical studies investigating 11 targeted anticancer agents (alemtuzumab, rituximab, imatinib, dasatinib, erlotinib, vandetanib, sorafenib, cabozantinib, pazopanib, everolimus, and temsirolimus) were analyzed. The most frequently encountered dermatologic AEs were rash (127/660; 19%), xerosis (18/100; 18%), mucositis (68/402; 17%), and pruritus (12/169; 7%). Other AEs included pigmentary abnormalities of the skin/hair (13%), hair disorders (trichomegaly, hypertrichosis, alopecia, and madarosis; 14%), urticaria (7%), palmoplantar erythrodysesthesia (7%), erythema, acne, purpura, skin fissures, other 'unknown skin changes', exanthem, infection, flushing, telangiectasia, and photosensitivity. This study describes the dermatologic manifestations of targeted anticancer therapy-related AEs in the pediatric population. Since these AEs are often associated with significant morbidity, it is imperative that pediatric oncologists be familiar with their recognition and management, to avoid unnecessary dose modifications and/or termination, and to prevent impairments in patients' quality of life.

Adverse Events in Pediatric Patients Receiving Long-Term Outpatient Antimicrobials.

Although long treatment courses of outpatient antimicrobials are often used in pediatric patients, few data exist regarding the frequency of adverse events (AEs) associated with these medications. We performed a retrospective cohort study of all patients seen in the Infectious Diseases clinic at a tertiary referral children's hospital from August 1, 2009 to August 1, 2011. We included patients who received ≥14 days of oral or intravenous antibiotic, antiviral, or antifungal medications. Patients receiving only prophylactic medications or human immunodeficiency virus treatment were excluded. Three hundred thirty-five subjects met inclusion criteria, with a median age of 7.4 years at start of therapy. The cohort was predominantly male (60%), white (54%), and previously healthy (59%). A majority (88.4%) of subjects were treated for bacterial infections. β-Lactam agents were the most commonly used antimicrobial class (210 subjects; 62.7%), followed by clindamycin (86; 25.7%), rifampin (76; 22.7%), and vancomycin (62; 18.5%). Overall, 107 (31.9%) subjects experienced 151 distinct AEs. The most common individual AE noted was diarrhea (44; 29.1% of all AEs). Serious AEs developed in 42 (12.5%) subjects, including allergic reactions (15; 11.3% of all AEs), venous catheter-related complications (14; 13.0% of those with catheters), neutropenia (9; 3.0%), renal insufficiency (7; 2.5%), and hepatotoxicity (3; 1.1%). Rates of AEs were similar between those on oral and intravenous antimicrobials. In our study population, patients on prolonged oral or intravenous outpatient antimicrobials experienced AEs frequently. These findings support the need for close monitoring of pediatric patients on prolonged antimicrobial therapy and vigilance for unwanted effects of these medications.

Atropine therapy versus no atropine therapy for the prevention of adverse events in paediatric patients undergoing intubation

Atropine therapy versus no atropine therapy for the prevention of adverse events in paediatric patients undergoing intubation

Serum Concentrations of Mannan-Binding Lectin (MBL) and MBL-Associated Serine Protease-2 and the Risk of Adverse Events in Pediatric Patients With Cancer and Fever in Neutropenia.

It is unknown whether serum concentrations of mannan-binding lectin (MBL) and MBL-associated serine protease-2 (MASP-2) influence the risk of adverse events (AEs) in children with cancer presenting with fever in neutropenia (FN). Pediatric patients with cancer presenting with FN after non-myeloablative chemotherapy were observed in a prospective multicenter study. Mannan-binding lectin and MASP-2 were measured using commercially available enzyme-linked immunosorbent assay in serum taken at cancer diagnosis. Multiple FN episodes per patient were allowed. Associations of MBL and MASP-2 with AE in general, with bacteremia, and with serious medical complications (SMC) during FN were analyzed using mixed logistic regression. Of 278 FN episodes, AE was reported in 84 (30%), bacteremia was reported in 42 (15%), and SMC was reported in 16 (5.8%). Median MBL was 2152 ng/mL (range, 7-10 060). It was very low (<100) in 11 (9%) patients, low (100-999) in 36 (29%) patients, and normal (≥1000) in 79 (63%) patients. Median MASP-2 was 410 ng/mL (range, 68-2771). It was low (<200) in 18 (14%) patients and normal in the remaining 108 (86%) patients. Mannan-binding lectin and MASP-2 were not significantly associated with AE or bacteremia. Normal versus low MBL was independently associated with a significantly higher risk of SMC (multivariate odds ratio, 12.8; 95% confidence interval, 1.01-163; P = .050). Mannan-binding lectin and MASP-2 serum concentrations were not found to predict the risk to develop AEs or bacteremia during FN. Normal MBL was associated with an increased risk of SMC during FN. This finding, in line with earlier studies, does not support the concept of MBL supplementation in MBL-deficient children with cancer presenting with FN.

Prolonged Central Venous Desaturation Measured by Continuous Oximetry is Associated With Adverse Outcomes in Pediatric Cardiac Surgery

BACKGROUND The role of continuous central venous oxygen saturation (ScvO₂) oximetry during pediatric cardiac surgery for predicting adverse outcomes is not known. Using a recently available continuous ScvO₂ oximetry catheter, we examined the association between venous oxygen desaturations and patient outcomes. We hypothesized that central venous oxygen desaturations are associated with adverse clinical outcomes. METHODS Fifty-four pediatric patients undergoing cardiac surgery were prospectively enrolled in an unblinded observational study. ScvO₂ was measured continuously in the operating room and for up to 24 h post-Intensive Care Unit admission. The relationships between ScvO₂ desaturations, clinical outcomes, and major adverse events were determined. RESULTS More than 18 min of venous saturations less than 40% were associated with major adverse events with 100% sensitivity and 97.6% specificity. Significant correlations resulted between the ScvO₂ area under the curve less than 40% and creatinine clearance at 12 h in the Intensive Care Unit (r = -0.58), Intensive Care Unit length of stay (r = 0.56), max inotrope use (r = 0.52), inotrope use at 24 h (r = 0.40), inotrope index score (r = 0.39), hospital length of stay (r = 0.36), and length of intubation (r = 0.32). CONCLUSIONS We demonstrate that ScvO₂ desaturations by continuous oximetry are associated with major adverse events in pediatric patients undergoing cardiac surgery. The most significant associations with major adverse events are seen in patients with greater than 18 min of central venous saturations less than 40%. Our results support the further investigation of ScvO₂ as a potential target parameter in high-risk pediatric patients to minimize the risk of major adverse events.

Adverse Events in Sedated Intubated PICU Patients

Research Article| July 01 2012 Adverse Events in Sedated Intubated PICU Patients AAP Grand Rounds (2012) 28 (1): 9. https://doi.org/10.1542/gr.28-1-9 Views Icon Views Article contents Figures & tables Video Audio Supplementary Data Peer Review Share Icon Share Twitter LinkedIn Tools Icon Tools Get Permissions Cite Icon Cite Search Site Citation Adverse Events in Sedated Intubated PICU Patients. AAP Grand Rounds July 2012; 28 (1): 9. https://doi.org/10.1542/gr.28-1-9 Download citation file: Ris (Zotero) Reference Manager EasyBib Bookends Mendeley Papers EndNote RefWorks BibTex toolbar search nav search search input Search input auto suggest search filter All PublicationsAll JournalsAAP Grand RoundsPediatricsHospital PediatricsPediatrics In ReviewNeoReviewsAAP NewsAll AAP Sites Search Advanced Search Topics: adverse event, mechanical ventilation, pediatric intensive care unit, sedated state, sedation procedure, sedatives, respiratory insufficiency Source: Grant MJ, Scoppettuolo LA, Wypii D, et alfor the RESTORE Investigative Team. Prospective evaluation of sedation-related adverse events in pediatric patients ventilated for acute respiratory failure. Crit Care Med. 2012; 40(4): 1317– 1323; doi: https://doi.org/10.1097/CCM.0b013e31823c8ae3Google Scholar Investigators from multiple US hospitals report rates and severity of sedation-related adverse events (AEs) from an ongoing study (RESTORE) related to sedation management involving 22 participating PICUs. Eligible patients were children >2 weeks and <18 years of age who were intubated and mechanically ventilated for acute respiratory disease. AEs, defined as any untoward or unfavorable medical occurrence, were recorded based upon operational definitions for type and severity (severe, moderate, mild). Data on the type of sedation administered and levels of pain, agitation, and withdrawal were prospectively collected using validated age-appropriate tools. The investigators reported the overall rate of AEs and... You do not currently have access to this content.

Prospective evaluation of sedation-related adverse events in pediatric patients ventilated for acute respiratory failure*

Sedation-related adverse events in critically ill pediatric patients lack reproducible operational definitions and reference standards. Understanding these adverse events is essential to improving the quality of patient care and for developing prevention strategies in critically ill children. The purpose of this study was to test operational definitions and estimate the rate and site-to-site heterogeneity of sedation-related adverse events. Prospective cohort study. Twenty-two pediatric intensive care units in the United States enrolling baseline patients into a prerandomization phase of a multicenter trial on sedation management. Pediatric patients intubated and mechanically ventilated for acute respiratory failure. Analysis of adverse event data using consistent operational definitions from a Web-based data management system. There were 594 sedation-related adverse events reported in 308 subjects, for a rate of 1.9 adverse events per subject and 16.6 adverse events per 100 pediatric intensive care unit days. Fifty-four percent of subjects had at least one adverse event. Seven (1%) adverse events were classified as severe, 347 (58%) as moderate, and 240 (40%) as mild. Agitation (30% of subjects, 41% of events) and pain (27% of subjects, 29% of events) were the most frequently reported events. Eight percent of subjects (n = 24) experienced 54 episodes of clinically significant iatrogenic withdrawal. Unplanned endotracheal tube extubation occurred at a rate of 0.82 per 100 ventilator days, and 32 subjects experienced postextubation stridor. Adverse events with moderate intraclass correlation coefficients included: Inadequate sedation management (intraclass correlation coefficient = 0.130), clinically significant iatrogenic withdrawal (intraclass correlation coefficient = 0.088), inadequate pain management (intraclass correlation coefficient = 0.080), and postextubation stridor (intraclass correlation coefficient = 0.078). Operational definitions for sedation-related adverse events were consistently applied across multiple pediatric intensive care units. Adverse event rates were different from what has been previously reported in single-center studies. Many adverse events have moderate intraclass correlation coefficients, signaling site-to-site heterogeneity.

IV paracetamol effect on propofol–ketamine consumption in paediatric patients undergoing ESWL

Electroshock wave lithotripsy (ESWL) is a painful procedure performed with sedoanalgesia in paediatric patients. The propofol-ketamine combination may be the preferable anaesthesia for this procedure, and propofol-ketamine consumption may be decreased with the administration of intravenous (IV) paracetamol. In this study we investigated the effect of IV paracetamol administration on propofol-ketamine consumption, recovery time and frequency of adverse events in paediatric patients undergoing ESWL. Sixty children, ranging in age from 1 to 10 years and with American Society of Anesthesiologists Physical Status 1-2, were included in this prospective, randomized, double-blinded study. Thirty minutes prior to the procedure children randomly assigned to Group I received IV 15 mg/kg paracetamol, and those randomly assigned to Group II received 1.5 mL/kg IV saline infusion 30 min. The propofol-ketamine combination was prepared by mixing 25 mg propofol and 25 mg ketamine in a total 10 mL solution in the same syringe. After the administration of 0.1 mg/kg midazolam and 10 μg/kg atropine to both groups and during the procedure, the propofol-ketamine combination was administered at 0.5 mg/kg doses to achieve a Wisconsin sedation score of 1 or 2. Oxygen saturation and heart rate were recorded at 5-min intervals. Propofol-ketamine consumption, recovery times and adverse events were also recorded. Demographic data were similar between groups. Propofol-ketamine consumption (Group I, 25.2 ± 17.7 mg; Group II, 35.4 ± 20.1 mg; p = 0.04) and recovery times (Group I, 19.4 ± 7.9 min; Group II, 29.6 ± 11.4 min; p < 0.0001) were significantly different between groups. Saturation, heart rate and adverse events were similar in both groups. Our data suggest that the administration of IV paracetamol decreases propofol-ketamine consumption for adequate sedation during ESWL procedures in paediatric patients and shortens recovery time.