Procedural sedation by advanced care paramedics for emergency gastrointestinal endoscopy

CJEM ◽  
2018 ◽  
Vol 21 (2) ◽  
pp. 235-242
Author(s):  
Hana M. Wiemer ◽  
Michael B. Butler ◽  
Patrick C. Froese ◽  
Allan Lapierre ◽  
Chris Carriere ◽  
...  
Keyword(s):  
Adverse Events ◽  
Propensity Scores ◽  
Medication Use ◽  
Preliminary Evidence ◽  
Procedural Sedation ◽  
Orthopedic Procedures ◽  
Data Set ◽  
Airway Intervention ◽  
American Society ◽  
Orthopedic Patients

AbstractObjectivesAt the QEII Health Sciences Centre Emergency Department (ED) in Halifax, Nova Scotia, advanced care paramedics (ACPs) perform procedural sedation and analgesia (PSA) for many indications, including orthopedic procedures. We have begun using ACPs as sedationists for emergent upper gastrointestinal (UGI) endoscopy. This study compares ACP-performed ED PSA for UGI endoscopy and orthopedic procedures in terms of adverse events, airway intervention, vasopressor requirement, and PSA medication use.MethodsA data set was built from an ED PSA quality control database matching 61 UGI endoscopy PSAs to 183 orthopedic PSAs by propensity scores calculated using age, gender, and the American Society of Anesthesiologists (ASA) classification. Outcomes assessed were hypotension (systolic BP<100 mm Hg or a 15% decrease from baseline), hypoxia (SaO2<90%), apnea (>30 sec), vomiting, arrhythmias, death, airway intervention, vasopressor requirement, and PSA medication use.ResultsUGI endoscopy patients experienced hypotension more frequently than orthopedic patients (OR=4.11, CI: 2.05-8.22) and required airway repositioning less often (OR=0.24, CI: 0.10-0.59). They received ketamine more frequently (OR=15.7, CI: 4.75-67.7) and fentanyl less often (OR=0.30, CI: 0.15-0.63) than orthopedic patients. Four endoscopy patients received phenylephrine, and one required intubation. No patient died in either group.ConclusionsIn ACP-led sedation for UGI endoscopy and orthopedic procedures, adverse events were rare with the notable exception of hypotension, which was more frequent in the endoscopy group. Only endoscopy patients required vasopressor treatment and intubation. We provide preliminary evidence that ACPs can manage ED PSA for emergent UGI endoscopy, although priorities must shift from pain control to hemodynamic optimization.

scholarly journals P139: Procedural sedation by advanced care paramedics for emergency GI endoscopy

CJEM ◽  
2016 ◽  
Vol 18 (S1) ◽  
pp. S124-S124
Author(s):  
H. Wiemer ◽  
M.B. Butler ◽  
P. Froese ◽  
D. Farina ◽  
A. Lapierre ◽  
...  
Keyword(s):  
Propensity Scores ◽  
Medication Use ◽  
Upper Airway ◽  
Massive Bleeding ◽  
Procedural Sedation ◽  
Orthopedic Procedures ◽  
Airway Intervention ◽  
Vasopressor Agent ◽  
Increased Risk ◽  
To Receive

Introduction: Acute upper gastrointestinal (UGI) bleeding is a relatively common emergency resulting in death in 6 to 8% of cases. UGI endoscopy is the intervention of choice which requires procedural sedation and analgesia (PSA). The Halifax Infirmary emergency department (ED) performs 1000 PSAs annually, performed by advanced care paramedics (ACPs). This has been shown safe for other indications for PSA, such as orthopedic procedures. Considering that UGI endoscopy involves upper airway manipulation, and patients are at an increased risk of massive bleeding, this procedure would be expected to be more complex and have an increased risk of adverse events (AEs). This study aims to compare PSA for UGI endoscopy performed by ACPs to that for orthopedic procedures for AEs, airway intervention and medication use. Methods: This study is a retrospective review of an ACP-performed ED PSA quality control database. A dataset was built matching 64 UGI endoscopy PSAs to 192 orthopedic PSAs by propensity scores calculated using age, gender and ASA classification. Outcomes assessed were hypotension (SBP < 100, or 15% decrease from baseline), hypoxia (SaO2 < 90), apnea (> 30sec), vomiting, arrhythmias and death in the ED. The need for airway intervention and medication use was assessed. Results: The UGI endoscopy group was 4.60 times more likely to suffer hypotension than the orthopedic group (OR=4.6, CI:2.2-9.6), and a fifth as likely to require airway repositioning (OR=0.2, CI:0.1-0.5). One endoscopy patient required endotracheal intubation. No patient died in either group. Compared to the orthopedic group, the UGI endoscopy group was one-third as likely to receive fentanyl (OR=0.3, CI:0.2-0.6). When fentanyl was administered, endoscopy patients received an average 26.7 mcg less than orthopedic patients. The endoscopy group was 15.4 times more likely to receive ketamine (OR=15.4, CI:4.7-66.5), and received 34.4 mg less on average. Four endoscopy patients received phenylephrine compared to none in the orthopedic group. There were no other differences. Conclusion: ED PSA for UGI endoscopy appears to differ significantly from that performed for orthopedic procedures. It was associated with more frequent hypotension and increased use of ketamine as a sedative. Patients undergoing UGI endoscopy were less likely to receive fentanyl and require airway repositioning. Only patients in the endoscopy group required intubation or a vasopressor agent.

scholarly journals A multicenter, prospective, single arm, open label, observational study of sTMS for migraine prevention (ESPOUSE Study)

Cephalalgia ◽  
2018 ◽  
Vol 38 (6) ◽  
pp. 1038-1048 ◽  
Author(s):  
Amaal J Starling ◽  
Stewart J Tepper ◽  
Michael J Marmura ◽  
Ejaz A Shamim ◽  
Matthew S Robbins ◽  
...  
Keyword(s):  
Adverse Events ◽  
Observational Study ◽  
Primary Endpoint ◽  
Medication Use ◽  
Responder Rate ◽  
Migraine Prevention ◽  
Performance Goal ◽  
Open Label ◽  
Data Set ◽  
Headache Diary

Objective To evaluate the efficacy and tolerability of single pulse transcranial magnetic stimulation (sTMS) for the preventive treatment of migraine. Background sTMS was originally developed for the acute treatment of migraine with aura. Open label experience has suggested a preventive benefit. The objective of this trial was to evaluate the efficacy and tolerability of sTMS for migraine prevention. Methods The eNeura SpringTMS Post-Market Observational U.S. Study of Migraine (ESPOUSE) Study was a multicenter, prospective, open label, observational study. From December 2014 to March 2016, patients with migraine (n = 263) were consented to complete a 1-month baseline headache diary followed by 3 months of treatment. The treatment protocol consisted of preventive (four pulses twice daily) and acute (three pulses repeated up to three times for each attack) treatment. Patients reported daily headache status, medication use, and device use with a monthly headache diary. The primary endpoint, mean reduction of headache days compared to baseline, was measured over the 28-day period during weeks 9 to 12. The primary endpoint was compared to a statistically-derived placebo estimate (performance goal). Secondary endpoints included: 50% responder rate, acute headache medication consumption, HIT-6, and mean reduction in total headache days from baseline of any intensity. Results Of a total of 263 consented subjects, 229 completed a baseline diary, and 220 were found to be eligible based on the number of headache days. The device was assigned to 217 subjects (Safety Data Set) and 132 were included in the intention to treat Full Analysis Set. For the primary endpoint, there was a −2.75 ± 0.40 mean reduction of headache days from baseline (9.06 days) compared to the performance goal (−0.63 days) ( p < 0.0001). The 50% responder rate of 46% (95% CI 37%, 56%) was also significantly higher ( p < 0.0001) than the performance goal (20%). There was a reduction of −2.93 (5.24) days of acute medication use, headache impact measured by HIT-6, −3.1 (6.4) ( p < 0.0001), and total headache days of any intensity −3.16 days (5.21) compared to the performance goal (−0.63 days) ( p < 0.0001). The most common adverse events were lightheadedness (3.7%), tingling (3.2%), and tinnitus (3.2%). There were no serious adverse events. Conclusions This open label study suggests that sTMS may be an effective, well-tolerated treatment option for migraine prevention. Trial registration number NCT02357381

Major Adverse Events and Relationship to Nil per Os Status in Pediatric Sedation/Anesthesia Outside the Operating Room

2016 ◽  
Vol 124 (1) ◽  
pp. 80-88 ◽  
Author(s):  
Michael L. Beach ◽  
Daniel M. Cohen ◽  
Susan M. Gallagher ◽  
Joseph P. Cravero
Keyword(s):  
Adverse Events ◽  
Odds Ratio ◽  
Pulmonary Complications ◽  
Data Set ◽  
Major Complications ◽  
Pediatric Sedation ◽  
American Society ◽  
Research Consortium ◽  
American Society Of Anesthesiologists ◽  
Major Adverse Events

Abstract Background Studies that have attempted to define the incidence of aspiration or pulmonary complications during sedation/anesthesia of children with respect to nil per os (NPO) status or other factors are difficult because of the relatively infrequent rate of these complications. Methods The Pediatric Sedation Research Consortium consists of 42 participating institutions with elective sedation services that submit consecutive patient encounter information to a central database. The authors evaluated aspiration episodes and a combined outcome of major adverse events (defined as aspiration, death, cardiac arrest, or unplanned hospital admission) with respect to NPO status, American Society of Anesthesiologists physical status, age, propofol use, procedure types, and urgency of the procedure. Results A total of 139,142 procedural sedation/anesthesia encounters were collected between September 2, 2007 and November 9, 2011. There were 0 deaths, 10 aspirations, and 75 major complications. NPO status was known for 107,947 patients, of whom 25,401 (23.5 %) were not NPO. Aspiration occurred in 8 of 82,546 (0.97 events per 10,000) versus 2 of 25,401 (0.79 events per 10,000) patients who were NPO and not NPO, respectively (odds ratio, 0.81; 95% CI, 0.08 to 4.08; P = 0.79). Major complications occurred in 46 of 82,546 (5.57 events per 10,000) versus 15 of 25,401 (5.91 events per 10,000) (odds ratio, 1.06; 95% CI, 0.55 to 1.93; P = 0.88). Multivariate adjustment did not appreciably impact the effect of NPO status. Conclusions The analysis suggests that aspiration is uncommon. NPO status for liquids and solids is not an independent predictor of major complications or aspiration in this sedation/anesthesia data set.

scholarly journals Efficacy and Safety of Pediatric Procedural Sedation Outside the Operating Room

2020 ◽  
Vol 10 (4) ◽  
Author(s):  
Thitima Sirimontakan ◽  
Ninuma Artprom ◽  
Nattachai Anantasit
Keyword(s):  
Adverse Events ◽  
Operating Room ◽  
Demographic Data ◽  
Procedural Sedation ◽  
Efficacy And Safety ◽  
Serious Adverse Events ◽  
Physical Status Classification ◽  
Sedation And Analgesia ◽  
American Society ◽  
American Society Of Anesthesiologists

Background: The volume of pediatric Procedural Sedation and Analgesia (PSA) outside the operating room has been increasing. This high clinical demand leads non-anesthesiologists, especially pediatric intensivists, pediatricians, and emergency physicians, to take a role in performing procedural sedation. Our department has established the PSA service by pediatric intensivists since 2015. Objectives: We aimed to assess the efficacy and safety of PSA outside the operating room conducted by pediatric intensivists and identify risk factors for severe adverse events. Methods: This was a retrospective descriptive study conducted from January 2015 to July 2019. Children aged less than 20 years who underwent procedural sedation were included. We collected demographic data, sedative and analgesic medications, American Society of Anesthesiologists (ASA) Physical Status Classification, indications for sedation, the success of procedural sedation, and any adverse events. Results: Altogether, 395 patients with 561 procedural sedation cases were included. The median age was 55 months (range: 15 to 119 months), and 58.5% (231/395) were male. The rate of successful procedures under PSA was 99.3%. Serious Adverse Events (SAE) occurred in 2.7%. Patients who received more than three sedative medications had higher SAE than patients who received fewer medications (adjusted for age, location of sedation, type of procedure, and ASA classification) (odds ratio: 8.043; 95% CI: 2.472 - 26.173, P = 0.001). Conclusions: Our data suggest that children who undergo procedural sedation outside the operating room conducted by pediatric intensivists are safe and effectively treated. Receiving more than three sedative medications is the independent risk factor associated with serious adverse events.

scholarly journals Between- and within-site variation in medication choices and adverse events during procedural sedation for electrical cardioversion of atrial fibrillation and flutter

CJEM ◽  
2017 ◽  
Vol 20 (3) ◽  
pp. 370-376 ◽  
Author(s):  
David Clinkard ◽  
Ian Stiell ◽  
Eddy Lang ◽  
Stuart Rose ◽  
Catherine Clement ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Adverse Events ◽  
Secondary Analysis ◽  
Procedural Sedation ◽  
Data Set ◽  
Recent Onset ◽  
Direct Current Cardioversion ◽  
Increased Risk ◽  
Atrial Fibrillation And Flutter ◽  
Onset Atrial Fibrillation

ABSTRACTObjectivesAlthough procedural sedation for cardioversion is a common event in emergency departments (EDs), there is limited evidence surrounding medication choices. We sought to evaluate geographic and temporal variation in sedative choice at multiple Canadian sites, and to estimate the risk of adverse events due to sedative choice.MethodsThis is a secondary analysis of one health records review, the Recent Onset Atrial Fibrillation or Flutter-0 (RAFF-0 [n=420, 2008]) and one prospective cohort study, the Recent Onset Atrial Fibrillation or Flutter-1 (RAFF-1 [n=565, 2010 – 2012]) at eight and six Canadian EDs, respectively. Sedative choices within and among EDs were quantified, and the risk of adverse events was examined with adjusted and unadjusted comparisons of sedative regimes.ResultsIn RAFF-0 and RAFF-1, the combination of propofol and fentanyl was most popular (63.8% and 52.7%) followed by propofol alone (27.9% and 37.3%). There were substantially more adverse events in the RAFF-0 data set (13.5%) versus RAFF-1 (3.3%). In both data sets, the combination of propofol/fentanyl was not associated with increased adverse event risk compared to propofol alone.ConclusionThere is marked variability in procedural sedation medication choice for a direct current cardioversion in Canadian EDs, with increased use of propofol alone as a sedation agent over time. The risk of adverse events from procedural sedation during cardioversion is low but not insignificant. We did not identify an increased risk of adverse events with the addition of fentanyl as an adjunctive analgesic to propofol.

scholarly journals Efficacy and safety of nintedanib in patients with idiopathic pulmonary fibrosis who are elderly or have comorbidities

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Ian Glaspole ◽  
Francesco Bonella ◽  
Elena Bargagli ◽  
Marilyn K. Glassberg ◽  
Fabian Caro ◽  
...  
Keyword(s):  
Idiopathic Pulmonary Fibrosis ◽  
Pulmonary Fibrosis ◽  
Adverse Events ◽  
Treatment Discontinuation ◽  
Efficacy And Safety ◽  
Data Set ◽  
Proactive Management ◽  
Comorbidity Burden ◽  
Rate Of Decline ◽  
The Impact

Abstract Background Idiopathic pulmonary fibrosis (IPF) predominantly affects individuals aged > 60 years who have several comorbidities. Nintedanib is an approved treatment for IPF, which reduces the rate of decline in forced vital capacity (FVC). We assessed the efficacy and safety of nintedanib in patients with IPF who were elderly and who had multiple comorbidities. Methods Data were pooled from five clinical trials in which patients were randomised to receive nintedanib 150 mg twice daily or placebo. We assessed outcomes in subgroups by age < 75 versus ≥ 75 years, by < 5 and ≥ 5 comorbidities, and by Charlson Comorbidity Index (CCI) ≤ 3 and > 3 at baseline. Results The data set comprised 1690 patients. Nintedanib reduced the rate of decline in FVC (mL/year) over 52 weeks versus placebo in patients aged ≥ 75 years (difference: 105.3 [95% CI 39.3, 171.2]) (n = 326) and < 75 years (difference 125.2 [90.1, 160.4]) (n = 1364) (p = 0.60 for treatment-by-time-by-subgroup interaction), in patients with < 5 comorbidities (difference: 107.9 [95% CI 65.0, 150.9]) (n = 843) and ≥ 5 comorbidities (difference 139.3 [93.8, 184.8]) (n = 847) (p = 0.41 for treatment-by-time-by-subgroup interaction) and in patients with CCI score ≤ 3 (difference: 106.4 [95% CI 70.4, 142.4]) (n = 1330) and CCI score > 3 (difference: 129.5 [57.6, 201.4]) (n = 360) (p = 0.57 for treatment-by-time-by-subgroup interaction). The adverse event profile of nintedanib was generally similar across subgroups. The proportion of patients with adverse events leading to treatment discontinuation was greater in patients aged ≥ 75 years than < 75 years in both the nintedanib (26.4% versus 16.0%) and placebo (12.2% versus 10.8%) groups. Similarly the proportion of patients with adverse events leading to treatment discontinuation was greater in patients with ≥ 5 than < 5 comorbidities (nintedanib: 20.5% versus 15.7%; placebo: 12.1% versus 10.0%). Conclusions Our findings suggest that the effect of nintedanib on reducing the rate of FVC decline is consistent across subgroups based on age and comorbidity burden. Proactive management of adverse events is important to reduce the impact of adverse events and help patients remain on therapy. Trial registration: ClinicalTrials.gov NCT00514683, NCT01335464, NCT01335477, NCT02788474, NCT01979952.

scholarly journals Use of potentially inappropriate medications among ambulatory home-dwelling elderly patients with dementia: A review of the literature

2017 ◽  
Vol 150 (3) ◽  
pp. 169-183 ◽  
Author(s):  
Tejal Patel ◽  
Karen Slonim ◽  
Linda Lee
Keyword(s):  
Older Adults ◽  
Cognitive Impairment ◽  
Adverse Events ◽  
Inappropriate Medication ◽  
Medication Use ◽  
Adverse Outcomes ◽  
Potentially Inappropriate Medication ◽  
Potentially Inappropriate Medications ◽  
Inappropriate Medication Use ◽  
Inappropriate Medications

Background: Older adults with dementia are at high risk for drug-related adverse outcomes. While much is known about potentially inappropriate medication use in older adults, its prevalence and characteristics among those with dementia are not as well elucidated. We conducted a literature review to examine the prevalence of potentially inappropriate medication use among home-dwelling older adults with dementia. Our secondary aim was to determine the most frequently implicated medications and factors associated with potentially inappropriate medication use. Methods: MEDLINE, EMBASE, CINAHL, and International Pharmaceutical Abstracts were searched between 1946 and 2014 for articles that referenced potentially inappropriate medication use and types of dementia. One reviewer screened all titles and abstracts from the initial search and full-text articles after the initial screen for eligibility, then 2 reviewers independently abstracted data from included studies. Results: Searches yielded 81 articles, of which 7 met inclusion criteria. Prevalence of potentially inappropriate medication use varied from 15% to 46.8%. No single drug or drug class was reported consistently across all studies as the most frequent potentially inappropriate medication, but anticholinergics and benzodiazepines, drugs that affect cognition, were among the most common medications or pharmacological classes listed. Discussion: Older adults with dementia may be particularly vulnerable to potentially inappropriate medications because of cognitive impairment from their condition and the greater likelihood of experiencing adverse events from medications. Given this population’s greater susceptibility to adverse events, more intense medication and patient monitoring may be warranted, especially among those taking anticholinergics and benzodiazepines, as these drugs can contribute to cognitive impairment.

scholarly journals Does the sedation regimen affect adverse events during procedural sedation and analgesia in injection drug users?

CJEM ◽  
2013 ◽  
Vol 15 (05) ◽  
pp. 279-288 ◽  
Author(s):  
Frank Xavier Scheuermeyer ◽  
Gary Andolfatto ◽  
Hong Qian ◽  
Eric Grafstein
Keyword(s):  
Adverse Events ◽  
Injection Drug Users ◽  
Drug Users ◽  
Vital Signs ◽  
Injection Drug ◽  
Procedural Sedation ◽  
Secondary Outcome ◽  
Procedural Sedation And Analgesia ◽  
Pearson Coefficient ◽  
Sedation And Analgesia

ABSTRACT Objectives: Injection drug users (IDUs) often undergo procedural sedation and analgesia (PSA) as part of emergency department (ED) treatment. We compared adverse events (AEs) using a variety of sedation regimens. Methods: This was a retrospective analysis of a PSA safety audit in two urban EDs. Consecutive self-reported IDUs were identified, and structured data describing comorbidities, vital signs, sedation regimens (propofol [P], propofol-fentanyl [PF], fentanyl-midazolam [FM], ketofol [1:1 ketamine:propofol, KF], and ketamine-propofol [KP]) and AEs were collected. The primary outcome was the proportion of patients in each sedation group having an AE; the secondary outcome was the proportion of patients having a cardiovascular or respiratory AE. Results: Data were collected on 276 IDUs (78 P, 82 PF, 65 FM, 25 KF, and 26 KP), and 18 patients had AEs (6.5%, 95% CI 4.0–10.3). The AE rates were 0.0%, 8.5%, 9.2%, 12.0%, and 7.6%, respectively, with propofol having a significantly lower rate (Pearson coefficient 14.9, p = 0.007). The cardiovascular/respiratory AE rates were significantly different as well, with P, KP, and KF having the lowest rates (Pearson coefficient 13.3, p = 0.01). Conclusions: For IDU PSA, the overall AE rate was 6.5%, and propofol appeared to have a significantly lower rate.

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