AB0439 Adverse Events after Surgery in Pediatric Patients with SLE: A Nationwide Study

Background: This study aims to evaluate the frequency of and associated risk factors for adverse events caused by cardiac catheterization procedures in pediatric patients. Methods: Between January 2009 and January 2012, a total of 599 pediatric patients (320 males, 279 females; mean age 5.4±4.7 years; range, 1 day to 21 years) who underwent cardiac catheterization in our cardiac catheterization laboratory were retrospectively analyzed. Demographic and clinical data of the patients including the duration of the procedure, management of anesthesia, the American Society of Anesthesiologists class, and Catheterization Risk Score for Pediatrics, and procedure-related serious adverse events were recorded. Results: The incidence of procedure-related serious adverse events was 9.18%. Potential risk factors associated with serious adverse events were identified as interventional heart catheterization, high scores obtained from the Catheterization Risk Score for Pediatrics, the use of endotracheal tube in airway control, and prolonged procedural duration. Conclusion: Our study results suggest that prolonged duration of catheterization is a potential risk factor for procedure-related adverse events and the duration of the procedure needs to be included as a variable in the Catheterization Risk Score for Pediatrics scoring system for predicting procedure-related adverse events.

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Excess Morbidity Associated With Interhospital Transport

PEDIATRICS ◽

10.1542/peds.90.6.893 ◽

1992 ◽

Vol 90 (6) ◽

pp. 893-898 ◽

Cited By ~ 1

Author(s):

Robert K. Kanter ◽

Nancy M. Boeing ◽

William P. Hannan ◽

Deborah L. Kanter

Keyword(s):

Intensive Care ◽

Adverse Events ◽

Critically Ill ◽

Pediatric Patients ◽

Morbidity Rate ◽

Control Group ◽

Interhospital Transfer ◽

Excess Morbidity ◽

Interhospital Transport ◽

And Control

A prospective study was performed to determine whether excess morbidity occurred in critically ill and injured pediatric patients during interhospital transport compared with morbidity in a control group. Control observations were made during the first 2 hours of pediatric intensive care unit (PICU) care of patients emergently admitted from within the same institution and not requiring interhospital transport. The first 2 PICU hours of control patients corresponded to the interval of transport in those who required interhospital transfer. Transport care was provided by nonspecialized teams from referring hospitals. Morbidity occurred in 20.9% of 177 transported patients, exceeding the morbidity rate of 11.3% in 195 control patients (P < .05). The difference in morbidity was due to intensive care-related adverse events (eg, plugged or dislodged endotracheal tubes, loss of intravenous access) in 15.3% and 3.6% of transported and control patients, respectively (P < .05). Physiologic deterioration occurred at similar rates of 7.9% and 8.7% in transported and control patients, respectively (P > .05). Slightly greater pre-ICU severity of illness in transported than control patients (median Pediatric Risk of Mortality Score = 10 and 7, respectively, P < .05) and greater pre-ICU therapy relative to severity (P < .05) in control patients are potential confounding sources of the morbidity differences. If patients are stratified into subgroups of similar pre-ICU severity, an excess of intensive care-related adverse events in transported patients remains evident in the severe subgroup (P < .05). Further investigation is warranted to determine whether specialized transport teams can reduce the excess morbidity associated with interhospital transport of critically ill and injured pediatric patients.

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Successful Use of Intravenous Methylnaltrexone for Opioid-Induced Constipation in Critically Ill Pediatric Patients

Journal of Pediatric Intensive Care ◽

10.1055/s-0041-1736335 ◽

2021 ◽

Author(s):

Kimberly P. Mills ◽

Christopher C. McPherson ◽

Ahmed S. Said ◽

Michael A. Lahart

Keyword(s):

Adverse Events ◽

Critically Ill ◽

Primary Outcome ◽

Pediatric Patients ◽

Case Series ◽

Opioid Withdrawal ◽

Limited Data ◽

Serious Adverse Events ◽

Patient Response ◽

Hospital Patients

Abstract Objectives Methylnaltrexone is U.S. Food and Drug Administration (FDA) approved as a subcutaneous injection for adults with opioid-induced constipation (OIC). Case series have described the use of methylnaltrexone for OIC in the pediatric oncology population. There are limited data describing its intravenous use in critically ill pediatric patients. Methods We conducted a retrospective observational study at St. Louis Children's Hospital. Patients less than 18 years old who received at least one dose of intravenous methylnaltrexone while admitted to an intensive care unit between January 2016 and August 2019 were included. The primary outcome was documented laxation within 24 hours of methylnaltrexone administration. Results Sixteen patients received a total of 34 doses of intravenous methylnaltrexone. Patients received a median of 1.69 (interquartile range [IQR], 0.9–4.86) morphine milligram equivalents per kilogram per 24 hours, over a median of 14 days (IQR, 11–30), before methylnaltrexone administration. The median dose of methylnaltrexone was 0.15 mg/kg (IQR, 0.15–0.16). Ten patients (63%) responded to the first dose of methylnaltrexone, and 14 patients (88%) responded to at least one dose. Overall, 26 doses (76%) led to patient response. Four patients (25%) experienced adverse events (emesis, abdominal pain) after methylnaltrexone administration. No signs or symptoms of opioid withdrawal were documented. Conclusions Intravenous methylnaltrexone appears to be safe and effective in treating OIC in critically ill pediatric patients. No serious adverse events or signs of opioid withdrawal were observed after single and repeat dosing. Patients responded to methylnaltrexone with varying opioid dosing and durations prior to administration.

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Safety and Tolerability of Adjunctive Eslicarbazepine Acetate in Pediatric Patients (Aged 4-17 Years) With Focal Seizures

Journal of Child Neurology ◽

10.1177/0883073819890997 ◽

2019 ◽

Vol 35 (4) ◽

pp. 265-273 ◽

Cited By ~ 4

Author(s):

Mark Mintz ◽

Jesus E. Pina-Garza ◽

Steven M. Wolf ◽

Patricia E. McGoldrick ◽

Sergiusz Józwiak ◽

...

Keyword(s):

Adverse Events ◽

Pediatric Patients ◽

Safety Data ◽

Adjunctive Treatment ◽

Eslicarbazepine Acetate ◽

Serious Adverse Events ◽

Double Blind ◽

Focal Seizures ◽

Clear Dose Response ◽

Cluster Seizures

Objective: To evaluate the safety and tolerability of adjunctive eslicarbazepine acetate (ESL) in pediatric patients (aged 4-17 years) with refractory focal seizures. Methods: Pooled safety data from patients aged 4-17 years in Study 208 (NCT01527513) and Study 305 (NCT00988156) were analyzed. Both were randomized, double-blind, placebo-controlled studies of ESL as adjunctive treatment in pediatric patients with refractory focal seizures receiving 1 or 2 antiepileptic drugs. Incidences of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), TEAEs leading to discontinuation, and TEAEs of special interest were evaluated. Results: The safety population comprised 362 patients (placebo, n = 160; ESL, n = 202). The overall incidence of TEAEs was similar between the ESL (67.8%) and placebo groups (65.6%), with no clear dose-response relationship. The most frequently reported TEAEs with ESL were headache, somnolence, vomiting, and diplopia. Overall incidences of SAEs and TEAEs leading to discontinuation were higher with ESL versus placebo (9.9% vs 5.0% and 5.9% vs 2.5%, respectively). The majority of SAEs with ESL occurred in Study 305. Two deaths were reported, 1 with ESL (0.5%) due to cluster seizures (resulting in herniation of the cerebellar tonsils) and 1 with placebo (0.6%) due to asphyxia. TEAEs related to allergic reaction, hyponatremia, hypothyroidism, cytopenia, seizure exacerbation, cognitive dysfunction, psychiatric disorders, or suicide occurred infrequently (<9%). Conclusion: Adjunctive ESL was generally well tolerated in children aged 4-17 years with focal seizures. The safety profile of ESL in children was comparable to that observed in adults.

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Prolonged Central Venous Desaturation Measured by Continuous Oximetry Is Associated with Adverse Outcomes in Pediatric Cardiac Surgery

Anesthesiology ◽

10.1097/aln.0b013e318233056e ◽

2011 ◽

Vol 115 (5) ◽

pp. 1033-1043 ◽

Cited By ~ 16

Author(s):

Ryan Crowley ◽

Elizabeth Sanchez ◽

Jonathan K. Ho ◽

Kate J. Lee ◽

Johanna Schwarzenberger ◽

...

Keyword(s):

Intensive Care Unit ◽

Cardiac Surgery ◽

Intensive Care ◽

Length Of Stay ◽

Adverse Events ◽

Clinical Outcomes ◽

Pediatric Patients ◽

Adverse Outcomes ◽

Central Venous ◽

Major Adverse Events

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.

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