Office-Based Anesthesia: Safety and Outcomes in Pediatric Dental Patients

The number of children with caries requiring general anesthesia to achieve comprehensive dental care and the demand for dentist anesthesiologists to provide ambulatory anesthesia for these patients is increasing. No current published studies examine the safety and outcomes of ambulatory anesthesia performed by dentist anesthesiologists for dental procedures in pediatric patients, and there is no national requirement for reporting outcomes of these procedures. In 2010, the Society for Ambulatory Anesthesia Clinical Outcomes Registry was developed. This Web-based database allows providers of ambulatory anesthesia to track patient demographics and various outcomes of procedures. Our study is a secondary analysis of data collected in the registry over a 4-year period, 2010–2014. Of the 7041 cases reviewed, no cases resulted in serious complications, including death, anaphylaxis, aspiration, cardiovascular adverse events, or neurologic adverse events. Of the 7041 cases reviewed, 196 (3.0%) resulted in a predischarge or postdischarge adverse event. The predischarge adverse event occurring with the highest frequency was laryngospasm, occurring in 35 cases (0.50%). The postdischarge adverse event occurring with the highest frequency was nausea, reported by 99 patients (5.0%). This study provides strong clinical outcomes data to support the safety of office-based anesthesia as performed by dentist anesthesiologists in the treatment of pediatric dental patients.

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A Clinical Audit of An Office-Based Anaesthesia Service for Dental Procedures in Victoria

Anaesthesia and Intensive Care ◽

10.1177/0310057x1804600410 ◽

2018 ◽

Vol 46 (4) ◽

pp. 404-413 ◽

Cited By ~ 2

Author(s):

A. Silvers ◽

A. Licina ◽

L. Jolevska

Keyword(s):

Adverse Event ◽

General Anaesthesia ◽

Demographic Data ◽

Day Surgery ◽

Adverse Event Rate ◽

Policy Documents ◽

Patient Demographics ◽

Physical Status Classification ◽

Dental Procedures ◽

American Society

There is an increasing number of specialties performing office-based procedures, with many different providers practising in this field. Office Based Anaesthesia Solutions is a private enterprise designed to be a high-quality general anaesthesia and sedation service delivering care across 18 dental practices in Victoria. We undertook a criterion-based audit of our practice standards and outcomes. Following ethics approval, we retrospectively reviewed consecutive patients managed by our service between March 2014 and July 2017. We collected demographic data, information about anaesthesia technique, and surgical features. We assessed our findings against the Australian and New Zealand College of Anaesthetists (ANZCA) day surgery policy documents. During the specified period, we provided anaesthesia or sedation for 1,323 patients. Their ages ranged from two to 93 years (mean [standard deviation] 33.3 [18.6] years). Ninety-three percent of patients were American Society of Anesthesiologists (ASA) physical status classification 1 or 2. Patient demographics were in line with ANZCA day surgical policy documents. Total intravenous anaesthesia was used in 1,054 of the 1,096 documented general anaesthesia cases. There were three unplanned hospital transfers (annual incidence 0.07%). As this was the first Australian criteria-based audit of office-based anaesthesia (OBA) for dental procedures, we cannot compare our findings directly to previous studies. However, we feel that our patient demographics fell within acceptable ANZCA day procedure standards and our adverse event rate was both very low and similar to other published international adverse event rates. Our audit indicates that with careful screening processes, patient selection and medical governance, OBA is a viable model of care for patients undergoing dental procedures.

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Comparing Demographic Characteristics and Adverse Event Rates at Two Dermatologic Surgery Practices

Journal of Cutaneous Medicine and Surgery ◽

10.2310/7750.2014.13119 ◽

2014 ◽

Vol 18 (5) ◽

pp. 337-340 ◽

Cited By ~ 6

Author(s):

Jenna L. O'Neill ◽

Brandon Shutty ◽

Yun Sun Lee ◽

James A. Solomon ◽

Nikita Patel ◽

...

Keyword(s):

Adverse Event ◽

Adverse Events ◽

Geographic Location ◽

Common Adverse Event ◽

Adverse Event Rate ◽

Dermatologic Surgery ◽

Patient Demographics ◽

Logistic Regression Procedure ◽

Event Rates ◽

Procedure Type

Background: Patient demographics and operative techniques may contribute to adverse events after surgeries. Objective: To identify differences in adverse event rates between different dermatologic surgery centers and potential contributing features affecting these rates. Methods: Data regarding demographics, procedure type, and adverse events were collected at two dermatologic surgery centers. Results: The most common adverse event at both sites was infection: 2.1% at site 1 versus 0.5% at site 2 ( p < .001). Using multivariate logistic regression, procedure type (Mohs surgery), geographic location (being at site 1), older age, and anatomic location of surgery were associated with a higher risk of infection. Conclusion: Adverse event rate appears to correlate with patient demographics, procedure type, and setting of surgery more than use of prophylactic antibiotics. Identification of differences in adverse event rates and potential contributing variables at different practices may allow for identification of opportunities to prevent adverse events.

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HyPE study: hydroxychloroquine prophylaxis-related adverse events’ analysis among healthcare workers during COVID-19 pandemic: a rising public health concern

Journal of Public Health ◽

10.1093/pubmed/fdaa074 ◽

2020 ◽

Vol 42 (3) ◽

pp. 493-503 ◽

Cited By ~ 4

Author(s):

Bada Sharanappa Nagaraja ◽

Kalhalli Narayanaswamy Ramesh ◽

Debjyoti Dhar ◽

Mahammad Samim Mondal ◽

Treshita Dey ◽

...

Keyword(s):

Cardiovascular Disease ◽

Adverse Event ◽

Adverse Events ◽

Healthcare Workers ◽

Cross Sectional Study ◽

Health Concern ◽

Cross Sectional ◽

Web Based ◽

Logistic Regression Models ◽

Younger Age

Abstract Background The rising burden of Coronavirus disease (COVID-19) has led to the mass use of hydroxychloroquine by healthcare workers (HCWs). Adverse event profile of this drug when used as prophylaxis is not well known in the literature. Methods A retrospective, cross-sectional study was conducted across the country using semi-structured web-based questionnaire among COVID-19 negative and asymptomatic healthcare workers, taking hydroxychloroquine prophylaxis. Descriptive and multivariate logistic-regression models were applied for analysis. Results Of the 166 participants, at least one adverse event was experienced by 37.9% participants, gastrointestinal being the most common (30.7%). Risk was higher in participants <40 years age (odd’s ratio (OR): 2.44, 95% confidence interval (CI): 1.18–5.05) and after first dose of hydroxychloroquine (51.2%, OR: 2.38, 95%CI: 1.17–4.84). Hydroxychloroquine prophylaxis was initiated without electrocardiography by 80.1% of HCWs. Only 21.6% of those with cardiovascular disease could get prior ECG. Conclusions A higher incidence of adverse events was observed when results were compared with studies involving patients on long-term hydroxychloroquine therapy. Younger age and first dose were associated with greater incidence of adverse events though all were self-limiting. Monitoring prior and during prophylaxis was inadequate even among those with cardiovascular disease and risk-factors. However, no serious cardiovascular events were reported.

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Retrospective Analysis of Medication Utilization and Clinical Outcomes in Patients With Idiopathic Pulmonary Fibrosis Treated With Nintedanib or Pirfenidone

Clinical Medicine Insights Circulatory Respiratory and Pulmonary Medicine ◽

10.1177/1179548419834922 ◽

2019 ◽

Vol 13 ◽

pp. 117954841983492 ◽

Cited By ~ 2

Author(s):

Anastasia Y Ipatova ◽

Pamela H Koerner ◽

Richard T Miller ◽

Francis Staskon ◽

Melanie Radi

Keyword(s):

Adverse Event ◽

Idiopathic Pulmonary Fibrosis ◽

Pulmonary Fibrosis ◽

Adverse Events ◽

Clinical Outcomes ◽

Interstitial Tissue ◽

Proportion Of Days Covered ◽

Average Proportion ◽

Specialty Pharmacy ◽

The Impact

Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive lung disease which results in thickening and scarring of the interstitial tissue. As the only 2 Food and Drug Administration (FDA)-approved medications on the market, it is valuable to compare the impact of nintedanib and pirfenidone on clinical outcomes. Records of patients who started nintedanib or pirfenidone between calendar years 2015 and 2016 at a national specialty pharmacy were retrospectively reviewed. Data collection was derived from patient management applications and statistical data analysis was completed in SAS (SAS Institute Inc®). The nintedanib population contained 2605 patients and of the population completing clinical assessment surveys (n = 1343), 46% of respondents (n = 612) reported no adverse events, with the remaining 54% reporting at least 1 adverse event. Average proportion of days covered (PDC) was 84.2% (SD = 17.0). Average final monthly copay for this group was $235. The pirfenidone population had 1322 patients, and of the surveyed population (n = 764), 58% of respondents (n = 445) reported no adverse events, with the remaining 42% reporting at least 1 adverse event. Average PDC was 83.4% (SD = 17.3). Average final monthly copay for this group was $339. Outcomes in the studied IPF population were similar for nintedanib and pirfenidone.

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Predicting adverse events in patients who are anxious about dental procedures

10.21203/rs.3.rs-39658/v1 ◽

2020 ◽

Author(s):

Yasunobu Oike ◽

Norito Takamura ◽

Jin Tokunaga ◽

Kenji Ogata ◽

Nao Setoguchi ◽

...

Keyword(s):

Adverse Event ◽

Adverse Events ◽

Pulse Rate ◽

Arterial Oxygen Saturation ◽

Vital Signs ◽

Mean Value ◽

Rate Change ◽

Arterial Oxygen ◽

Cutoff Values ◽

Dental Procedures

Abstract Background Dental extractions can cause significant anxiety making patients feel sick. In serious cases, extractions can cause unconsciousness and even death. Therefore, systemic adverse events must be completely avoided. We herein developed a method to predict dental extraction-related adverse events in patients. Methods The State-Trait Anxiety Inventory (STAIY-1) was administered before calculus removal and extraction, and STAIY-2 was administered before calculus removal in 93 patients (men, 44; women, 49). These patients were at a dental clinic for outpatient treatment. The vital signs like blood pressure, pulse rate, and arterial oxygen saturation and salivary amylase activity were measured at 2- and 4-min intervals before calculus removal as well as before extraction. Results Of the 93 patients, one man and one woman suffered from an adverse event. Maximum points for raw STAIY-1 scores were measured before extraction for both men and women, suggesting that performing the STAIY-1 survey prior to extraction is effective in predicting extraction-related adverse events. We also investigated rate changes (rate change = mean value during extraction − mean value during calculus removal/mean value during calculus removal) and mean pre-extraction pulse rates in patients who suffered from an adverse event. Adverse events occurred in men when there was a rate change of ≥ 0.225 and mean pre-extraction pulse rate was ≥ 90.0 bpm and in women when there was a rate change of ≥ 0.200 and the mean pre-extraction pulse rate was ≥ 95.0 bpm. We used these pulse rates as cutoff values. Conclusions Thus, the combined use of pre-extraction STAIY-1 results and pulse rate cutoff values could increase the success of predicting adverse events in such patients.

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Novel Adverse Events of Iloperidone: A Disproportionality Analysis in US Food and Drug Administration Adverse Event Reporting System (FAERS) Database

Current Drug Safety ◽

10.2174/1574886313666181026100000 ◽

2019 ◽

Vol 14 (1) ◽

pp. 21-26 ◽

Cited By ~ 2

Author(s):

Viswam Subeesh ◽

Eswaran Maheswari ◽

Hemendra Singh ◽

Thomas Elsa Beulah ◽

Ann Mary Swaroop

Keyword(s):

Data Mining ◽

Adverse Event ◽

Adverse Events ◽

Reporting System ◽

Adverse Event Reporting System ◽

Adverse Event Reporting ◽

Disproportionality Analysis ◽

Positive Signal ◽

Data Mining Algorithms ◽

Mining Algorithms

Background: The signal is defined as “reported information on a possible causal relationship between an adverse event and a drug, of which the relationship is unknown or incompletely documented previously”. Objective: To detect novel adverse events of iloperidone by disproportionality analysis in FDA database of Adverse Event Reporting System (FAERS) using Data Mining Algorithms (DMAs). Methodology: The US FAERS database consists of 1028 iloperidone associated Drug Event Combinations (DECs) which were reported from 2010 Q1 to 2016 Q3. We consider DECs for disproportionality analysis only if a minimum of ten reports are present in database for the given adverse event and which were not detected earlier (in clinical trials). Two data mining algorithms, namely, Reporting Odds Ratio (ROR) and Information Component (IC) were applied retrospectively in the aforementioned time period. A value of ROR-1.96SE>1 and IC- 2SD>0 were considered as the threshold for positive signal. Results: The mean age of the patients of iloperidone associated events was found to be 44years [95% CI: 36-51], nevertheless age was not mentioned in twenty-one reports. The data mining algorithms exhibited positive signal for akathisia (ROR-1.96SE=43.15, IC-2SD=2.99), dyskinesia (21.24, 3.06), peripheral oedema (6.67,1.08), priapism (425.7,9.09) and sexual dysfunction (26.6-1.5) upon analysis as those were well above the pre-set threshold. Conclusion: Iloperidone associated five potential signals were generated by data mining in the FDA AERS database. The result requires an integration of further clinical surveillance for the quantification and validation of possible risks for the adverse events reported of iloperidone.

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Adverse Effects of Natural Products: A Brief Pre-Systematic Review

Current Nutraceuticals ◽

10.2174/2665978601999200702163914 ◽

2020 ◽

Vol 01 ◽

Author(s):

Carla Pires ◽

Ana Fernandes

Keyword(s):

Systematic Review ◽

Adverse Event ◽

Natural Products ◽

Adverse Events ◽

In Vitro Study ◽

Google Scholar ◽

Inclusion Criteria ◽

Exclusion Criteria ◽

Meta Analyses

Background: Natural products are commonly used for treating health problems. These products may be associated with adverse events, which are defined as "noxious and unintended response to a medicinal product" by the European Medicine Agency. Objectives: To identify studies describing at least one adverse event (or with potential to promote an adverse event) related to the use of natural products, as well as to describe the involved product(s) and adverse event(s). Methods: A pre-systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses criteria. Keywords: "natural product(s)" and ["adverse drug reaction(s)" or "adverse effect(s)"]. Screened databases: PubMed, SciELO, DOAJ and Google Scholar. Inclusion criteria: papers describing at least one adverse event associated with the use of natural products and published between 2017 and 2019. Exclusion criteria: Repeated studies, reviews and papers written in other languages than English, Portuguese, French or Spanish. Results: 104 studies were identified (20 PubMed; 0 SciELO; 2 DOAJ; 82 Google Scholar), but only 10 were selected (4 PubMed and 6 Google Scholar): 1 in-vitro study; 2 non-clinical studies, 1 study reporting in-vitro and clinical data and 5 studies were cases reports. Globally, 997 reports of adverse drug reactions with natural products were identified, mainly non-severe cases. Conclusion: Since a limited number of studies was found, we conclude that adverse events due to natural products may be underreported, or natural products may have a good safety profile. This review contributes for assuring the safety of natural products consumers, by evaluating the knowledge/information on the potential adverse events and interactions of these products.

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EXPRESS: Altering the rehabilitation environment to improve stroke survivor activity (AREISSA): a Phase II trial.

International Journal of Stroke ◽

10.1177/17474930211006999 ◽

2021 ◽

pp. 174749302110069

Author(s):

Heidi Janssen ◽

Louise Ada ◽

Sandy Middleton ◽

Michael Pollack ◽

Michael Nilsson ◽

...

Keyword(s):

Adverse Events ◽

Clinical Outcomes ◽

Environmental Enrichment ◽

Brain Plasticity ◽

Social Activity ◽

Stroke Survivor ◽

Group Differences ◽

Control Group ◽

Serious Adverse Events ◽

Clinical Trial Registration

Background: Environmental enrichment involves organisation of the environment and provision of equipment to facilitate engagement in physical, cognitive and social activity. In animals with stroke, it promotes brain plasticity and recovery. Aims: To assess the feasibility and safety of a patient-driven model of environmental enrichment incorporating access to communal and individual environmental enrichment. Methods: A non-randomised cluster trial with blinded measurement involving people with stroke (n=193) in 4 rehabilitation units was carried out. Feasibility was operationalised as activity 10 days after admission to rehabilitation and availability of environmental enrichment. Safety was measured as falls and serious adverse events. Benefit was measured as clinical outcomes at 3 months, by an assessor blinded to group. Results: The experimental group (n=91) spent 7% (95% CI -14 to 0) less time inactive, 9% (95% CI 0 to 19) more time physically, and 6% (95% CI 2 to 10) more time socially active than the control group (n=102). Communal environmental enrichment was available 100% of the time, but individual environmental enrichment was rarely within reach (24%) or sight (39%). There were no between-group differences in serious adverse events or falls at discharge or 3 months nor in clinical outcomes at 3 months. Conclusions: This patient-driven model of environmental enrichment was feasible and safe. However, the very modest increase in activity by people with stroke, and the lack of benefit in clinical outcomes 3 months after stroke do not provide justification for an efficacy trial. Clinical Trial Registration: ANZCTR 12613000796785 Words: 245

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Adverse Events in Home-Care Nursing Agencies and Related Factors: A Nationwide Survey in Japan

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18052546 ◽

2021 ◽

Vol 18 (5) ◽

pp. 2546

Author(s):

Noriko Morioka ◽

Masayo Kashiwagi

Keyword(s):

Adverse Event ◽

Patient Safety ◽

Adverse Events ◽

Home Care ◽

Process Of Care ◽

Related Factors ◽

Cross Sectional ◽

Home Care Nursing ◽

Number Of Patients ◽

Care Nursing

Despite the importance of patient safety in home-care nursing provided by licensed nurses in patients’ homes, little is known about the nationwide incidence of adverse events in Japan. This article describes the incidence of adverse events among home-care nursing agencies in Japan and investigates the characteristics of agencies that were associated with adverse events. A cross-sectional nationwide self-administrative questionnaire survey was conducted in March 2020. The questionnaire included the number of adverse event occurrences in three months, the process of care for patient safety, and other agency characteristics. Of 9979 agencies, 580 questionnaires were returned and 400 were included in the analysis. The number of adverse events in each agency ranged from 0 to 47, and 26.5% of the agencies did not report any adverse event cases. The median occurrence of adverse events was three. In total, 1937 adverse events occurred over three months, of which pressure ulcers were the most frequent (80.5%). Adjusting for the number of patients in a month, the percentage of patients with care-need level 3 or higher was statistically significant. Adverse events occurring in home-care nursing agencies were rare and varied widely across agencies. The patients’ higher care-need levels affected the higher number of adverse events in home-care nursing agencies.

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The Association between Ranitidine Use and Gastrointestinal Cancers

Cancers ◽

10.3390/cancers13010024 ◽

2020 ◽

Vol 13 (1) ◽

pp. 24

Author(s):

Gerald McGwin

Keyword(s):

Adverse Event ◽

Adverse Events ◽

Reporting System ◽

Large Body ◽

Science Research ◽

Gastrointestinal System ◽

Gastrointestinal Cancers ◽

H2 Antagonists ◽

Study Results ◽

Risk Of Cancer

N-nitrosodimethylamine (NDMA) is a carcinogen in experimental animals. It has been classified a probable human carcinogen and has been found in ranitidine. This study sought to evaluate the association between ranitidine use and cancer of the gastrointestinal system. Events reported to the FDA Adverse Events Reporting System that were associated with the use of proton pump inhibitors (PPIs) and H2 antagonists were selected. Proportionate reporting ratios (PRRs) and associated 95% confidence intervals (CIs) were calculated to compare the proportion of all reported adverse events that were for gastrointestinal system cancers among adverse event reports for ranitidine to adverse event reports for other H2 antagonists. The proportion of adverse events for any gastrointestinal system cancer relative to all other events was elevated for ranitidine compared to PPIs and other H2 antagonists (PRR 3.66, 95% CI 3.19–4.20). Elevated and significant PRRs were observed for pharyngeal (PRR 9.24), esophageal (PRR 3.56), stomach (PRR 1.48), colorectal (PRR 16.31), liver (PRR 2.64), and pancreatic (PRR 2.18) cancers. The PRRs for anal (PRR 4.62) and gallbladder (PRR 4.62) cancer were also elevated though not statistically significant. In conjunction with a large body of epidemiologic and human and animal basic science research, the study results support the hypothesis that NDMA-contaminated ranitidine increases the risk of cancer and supports the withdrawal of these medications from the market.

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