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

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.

scholarly journals Safety of alemtuzumab in a nationwide cohort of Finnish multiple sclerosis patients

2021 ◽  
Author(s):  
Ilkka Rauma ◽  
Tiina Mustonen ◽  
Juha Matti Seppä ◽  
Maritta Ukkonen ◽  
Marianne Männikkö ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Adverse Events ◽  
Case Series ◽  
Retrospective Case ◽  
Serious Adverse Events ◽  
Highly Active ◽  
Disease Modifying Therapy ◽  
Case Series Study ◽  
Multiple Sclerosis Patients

Abstract Background Alemtuzumab is an effective disease-modifying therapy (DMT) for highly active multiple sclerosis (MS). However, safety concerns limit its use in clinical practice. Objectives To evaluate the safety of alemtuzumab in a nationwide cohort of Finnish MS patients. Methods In this retrospective case series study, we analyzed the data of all but two MS patients who had received alemtuzumab in Finland until 2019. Data were systematically collected from patient files. Results Altogether 121 patients were identified, most of whom had received previous DMTs (82.6%). Median follow-up time after treatment initiation was 30.3 months and exceeded 24 months in 78 patients. Infusion-associated reactions (IARs) were observed in 84.3%, 57.3%, and 57.1% of patients during alemtuzumab courses 1–3, respectively. Serious adverse events (SAEs) were observed in 32.2% of patients, serious IARs in 12.4% of patients, and SAEs other than IARs in 23.1% of patients. Autoimmune adverse events were observed in 30.6% of patients. One patient died of hemophagocytic lymphohistiocytosis, and one patient died of pneumonia. A previously unreported case of thrombotic thrombocytopenic purpura was documented. Conclusions SAEs were more frequent in the present cohort than in previous studies. Even though alemtuzumab is a highly effective therapy for MS, vigorous monitoring with a long enough follow-up time is advised.

scholarly journals The effect of the duration of the procedure on the risk of complications during pediatric cardiac catheterization

2020 ◽  
Vol 28 (3) ◽  
pp. 467-473
Author(s):  
Kübra Evren Şahin
Keyword(s):  
Risk Factors ◽  
Adverse Events ◽  
Cardiac Catheterization ◽  
Risk Score ◽  
Potential Risk ◽  
Pediatric Patients ◽  
Heart Catheterization ◽  
Serious Adverse Events ◽  
Cardiac Catheterization Laboratory ◽  
Study Results

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.

Excess Morbidity Associated With Interhospital Transport

PEDIATRICS ◽  
1992 ◽  
Vol 90 (6) ◽  
pp. 893-898 ◽  
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.

Abstract 104: Disability After Minor Stroke and TIA in the POINT Trial

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Brett L Cucchiara ◽  
Jordan Elm ◽  
J Donald Easton ◽  
Shelagh Coutts ◽  
Joshua Willey ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Adverse Events ◽  
Antiplatelet Therapy ◽  
Primary Outcome ◽  
Dual Antiplatelet Therapy ◽  
Recurrent Stroke ◽  
Primary Outcome Measure ◽  
Minor Stroke ◽  
Serious Adverse Events ◽  
Index Event

Background and Purpose: To assess the effect of combination antiplatelet therapy with aspirin and clopidogrel versus aspirin alone on disability following TIA or minor stroke and to identify factors associated with disability. Methods: The POINT trial randomized patients with TIA or minor stroke (NIHSS≤3) within 12 hours of onset to dual antiplatelet therapy (DAPT) with aspirin plus clopidogrel versus aspirin alone. The primary outcome measure was a composite of stroke, MI, or vascular death. We performed a post-hoc exploratory analysis to examine the effect of treatment on overall disability (defined as mRS>1) at 90 days as well as disability ascribed by the local investigator to index or recurrent stroke. We also evaluated predictors of disability. Results: At 90 days, 188/1964 (9.6%) of patients enrolled with TIA and 471/2586 (18.2%) of those enrolled with stroke were disabled. Overall disability was similar between patients assigned DAPT versus aspirin alone (14.7% vs. 14.3%, OR 0.97, 95%CI 0.82-1.14, p=0.69). However, there were numerically fewer patients with disability in conjunction with a primary outcome event in the DAPT arm (3.0% vs. 4.0%, OR 0.73, 95%CI 0.53-1.01, p=0.06), and significantly fewer patients in the DAPT arm with disability attributed by the investigators to either the index event or recurrent stroke (5.9% vs. 7.4%, OR 0.78, 95% CI 0.62-0.99, p=0.04). Notably, disability attributed to the index event accounted for the majority of this difference (4.5% vs. 6.0%, OR 0.74 95% CI 0.57-0.96, p=0.02). In multivariate analysis of patients enrolled with TIA, disability was significantly associated with age, subsequent ischemic stroke, serious adverse events, and major bleeding. In patients enrolled with stroke, disability was associated with female sex, hypertension, diabetes, NIHSS score, recurrent ischemic stroke, subsequent myocardial infarction, and serious adverse events. Conclusions: In addition to reducing recurrent stroke in patients with acute minor stroke and TIA, dual antiplatelet therapy might reduce stroke-related disability.

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

2019 ◽  
Vol 35 (4) ◽  
pp. 265-273 ◽  
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.

Treatment of patients with metastatic renal cell carcinoma (RCC) and end-stage renal disease (ESRD) with targeted therapy (TT): A case series.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 453-453 ◽  
Author(s):  
Amber Flaherty ◽  
Marc Ryan Matrana ◽  
Bradley J. Atkinson ◽  
Nizar M. Tannir
Keyword(s):  
Adverse Events ◽  
Clear Cell ◽  
Case Series ◽  
Median Number ◽  
Cancer Center ◽  
Limited Data ◽  
Inclusion Criteria ◽  
Md Anderson ◽  
Stage Renal Disease ◽  
End Stage

453 Background: Studies have shown that RCC is more prevalent in patients with ESRD, and RCC outcomes in patients with ESRD differ from those of the general RCC population. There is limited data regarding the use of TT in patients with metastatic RCC (mRCC) who are maintained on dialysis for ESRD. Methods: We retrospectively reviewed records of patients with mRCC who were seen at UT MD Anderson Cancer Center and received TT (sunitinib, sorafenib, pazopanib, temsirolimus, everolimus, erlotinib, or bevacizumab) over the last eight years (2003-2011) and who also had ESRD and underwent hemodialysis (HD) or peritoneal dialysis (PD). Overall survival (OS) was determined from initiation of TT to death. Results: Eleven patients (6 males; 8 with clear cell, 3 with papillary) were identified who met the above inclusion criteria. Median age was 57.4 years. Comorbidities included hypertension in 10, diabetes in 4, and hyperlipidemia in 6. Median number of TT was 4 (range, 1-6). Median time on treatment (TOT) was 769 days (range, 73-1792), Seven patients have died. Seven patients were on both HD and TT for over 1 year. Median OS was 1075 days (95% CI, 722-1428). TT related adverse events (AEs) included hypertension (HTN), hand-foot skin reaction (HFS), fatigue, diarrhea, rash and pneumonitis [Table]. There were no treatment related deaths. Conclusions: In this small retrospective series of patients with mRCC and ESRD who were treated with TT, adverse events were acceptable, and relatively prolonged disease courses were noted. [Table: see text]

scholarly journals Safety and Tolerability of a Rapid Transition From Intravenous Treprostinil to Oral Selexipag in Three Adolescent Patients With Pulmonary Arterial Hypertension

2021 ◽  
Vol 26 (5) ◽  
pp. 512-516
Author(s):  
Elizabeth Colglazier ◽  
Angelica J. Ng ◽  
Claire Parker ◽  
Hythem Nawaytou ◽  
Jeffrey R. Fineman
Keyword(s):  
Pulmonary Arterial Hypertension ◽  
Side Effects ◽  
Adverse Events ◽  
Pediatric Patients ◽  
Case Series ◽  
Inpatient Setting ◽  
Inpatient Hospitalization ◽  
Adolescent Patients ◽  
Rapid Transition ◽  
Pulmonary Arterial

There is limited published experience with transitioning pediatric patients from parenteral treprostinil to oral selexipag therapy. In addition, published transitions have typically been protracted, taking several weeks to complete. We present a case series of 3 adolescent patients who were transitioned from parenteral treprostinil to oral selexipag over a 5- to 7-day period. Their clinical courses leading up to the transitions are summarized and their outcomes are described. The 3 patients were successfully rapidly transitioned during an inpatient hospitalization without any observed adverse events or prostacyclin-related side effects. We conclude that when indicated rapid transition of parenteral to oral prostacyclin therapy may be performed safely in adolescents in an inpatient setting.

scholarly journals Efficacy and harms of remdesivir for the treatment of COVID-19: a systematic review and meta-analysis

2020 ◽  
Author(s):  
Alejandro Piscoya ◽  
Luis Fernando Ng-Sueng ◽  
Angela Parra del Riego ◽  
Renato Cerna-Viacava ◽  
Vinay Pasupuleti ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Clinical Improvement ◽  
Meta Analysis ◽  
Case Series ◽  
Length Of Hospital Stay ◽  
Invasive Ventilation ◽  
Serious Adverse Events ◽  
All Cause Mortality ◽  
Meta Analyses

AbstractBackgroundWe evaluated the efficacy and safety of remdesivir for the treatment of COVID-19.MethodsSystematic review in five engines, pre-print webpages and RCT registries until May 22, 2020 for randomized controlled trials (RCTs) and observational studies evaluating remdesivir on confirmed, COVID-19 adults with pneumonia and/or respiratory insufficiency. Primary outcomes were all-cause mortality, clinical improvement or recovery, need for invasive ventilation, and serious adverse events (SAE). Secondary outcomes included length of hospital stay, progression of pneumonia, and adverse events (AE). Inverse variance random effects meta-analyses were performed.ResultsTwo placebo-controlled RCTs (n=1300) and two case series (n=88) were included. All studies used remdesivir 200mg IV the first day and 100mg IV for 9 more days, and followed up until 28 days. Wang et al. RCT was stopped early due to AEs; ACTT-1 was preliminary reported at 15-day follow up. Time to clinical improvement was not decreased in Wang et al. RCT, but median time to recovery was decreased by 4 days in ACTT-1. Remdesivir did not decrease all-cause mortality (RR 0.71, 95%CI 0.39 to 1.28) and need for invasive ventilation at 14 days (RR 0.57, 95%CI 0.23 to 1.42), but had fewer SAEs (RR 0.77, 95%CI 0.63 to 0.94). AEs were similar between remdesivir and placebo arms. Risk of bias ranged from some concerns to high risk in RCTs.InterpretationThere is paucity of adequately powered and fully reported RCTs evaluating effects of remdesivir in adult, hospitalized COVID-19 patients. Remdesivir should not be recommended for the treatment of severe COVID-19.

scholarly journals Serious Adverse Events Associated With Hydroxychloroquine Amidst COVID-19 Pandemic: Case Series and Literature Review

Cureus ◽  
2020 ◽  
Author(s):  
Ramy Abdelmaseih ◽  
Randa Abdelmasih ◽  
Mustajab Hasan ◽  
Srikanth Tadepalli ◽  
Jigar Patel
Keyword(s):  
Literature Review ◽  
Adverse Events ◽  
Case Series ◽  
Serious Adverse Events

scholarly journals Spotlight on eltrombopag in pediatric ITP in China: a long-term observational study in real-world practice

2021 ◽  
Vol 5 (19) ◽  
pp. 3799-3806
Author(s):  
Xiaoling Cheng ◽  
LingLing Fu ◽  
Jingyao Ma ◽  
Hao Gu ◽  
Zhenping Chen ◽  
...  
Keyword(s):  
Adverse Events ◽  
Pediatric Patients ◽  
Complete Response ◽  
Term Treatment ◽  
Serious Adverse Events ◽  
Platelet Counts ◽  
Chronic Itp ◽  
Long Term Treatment ◽  
Concomitant Medications

Abstract Immune thrombocytopenia (ITP) is an autoimmune bleeding disorder with isolated thrombocytopenia and risk of hemorrhage. Treatment with eltrombopag increases and maintains hemostatic platelet counts; however, to date, long-term data are lacking on the outcome of children with ITP who are treated with eltrombopag. This prospective, observational, longitudinal cohort study evaluated the efficacy and safety of eltrombopag in pediatric patients with persistent or chronic ITP. For the 116 pediatric patients enrolled, duration of eltrombopag treatment was at least 3 months. Median effective dose was 25 mg/day, 50 mg/day, and 50 mg/day, respectively, for children age 5 years or younger, 6 to 11 years, or 12 years or older. In all, 89 patients (76.7%) achieved overall response, 53 (45.7%) achieved complete response, and 36 (31.0%) achieved response. Median platelet counts increased by week 1 and were sustained throughout the treatment period. During treatment with eltrombopag, the proportion of patients with grade 1 to 4 bleeding symptoms decreased from 83.61% at baseline to 9.88% at 6 months when only grade 1 was reported. Forty-three patients (37.1%) reported using concomitant medications at study entry, which was reduced to 1 patient (2.5%) who needed concomitant medications at 12 months. All adverse events were grade 1 or 2 according to Common Terminology Criteria for Adverse Events. No serious adverse events, cataracts, malignancies, or thromboses were reported during the study. Long-term treatment with eltrombopag was generally safe, well tolerated, and effective in maintaining platelet counts and reducing bleeding in most pediatric patients with persistent or chronic ITP. Combined with future studies, these findings will help establish how eltrombopag should best be used in the management of pediatric patients with East Asian ancestry.

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