The hemodynamic effects of intravenous paracetamol (acetaminophen) vs normal saline in cardiac surgery patients: A single center placebo controlled randomized study

Chiam, Elizabeth; Bellomo, Rinaldo; Чурилов, Леонид; Weinberg, Laurence

doi:10.1371/journal.pone.0195931

Cited by 15 publications

(10 citation statements)

References 23 publications

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“…Fentanyl and its derivatives show slight mast cell activation and are preferable. Paracetamol (acetaminophen) is not recommended, especially its intravenous administration, because it might cause severe hypotension due to reduction of cardiac output (84).…”

Section: Treatmentmentioning

confidence: 99%

Kounis Syndrome—not a Single-organ Arterial Disorder but a Multisystem and Multidisciplinary Disease

Kounis¹,

Koniari²,

Velissaris³

et al. 2019

Balkan Med J

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Coronary symptoms associated with conditions related to mast cell activation and inflammatory cell interactions, such as those involving T-lymphocytes and macrophages, further inducing allergic, hypersensitivity, anaphylactic, or anaphylactic insults, are currently referred to as the Kounis syndrome. Kounis syndrome is caused by inflammatory mediators released during allergic insults, postinflammatory cell activation, and interactions via multidirectional stimuli. A platelet subset of 20% with high-and low-affinity IgE surface receptors is also involved in this process. Kounis syndrome is not just a single-organ but also a complex multisystem and multiorgan arterial clinical condition; it affects the coronary, mesenteric, and cerebral arteries and is accompanied by allergy-hypersensitivityanaphylaxis involving the skin, respiratory, and vascular systems in the context of anesthesia, surgery, radiology, oncology, or even dental and psychiatric medicine; further, it has significantly influences both morbidity and mortality. Kounis syndrome might be caused by numerous and continuously increasing causes, with broad clinical symptoms and signs, via multi-organ arterial system involvement, in patients of any age, thereby demonstrating predominant anaphylactic features in terms of a wide spectrum of mast cell-association disorders. Cardiac symptoms, such as chest pain, coronary vasospasm, angina pectoris, myocardial infarction, stent thrombosis, acute cardiac failure, and sudden cardiac death associated with subclinical, clinical, acute, or chronic allergic reactions, constitute the clinical manifestations of this syndrome. Since its first description, a common pathway between allergic and non-allergic coronary events has been demonstrated. The hypothesis is based on the existence of a much higher degree of mast cell degranulation at plaque erosion or rupture sites compared with at the adjacent areas or even more distant segments in post-acute myocardial infarction of non-allergic etiology. Although mast cell activation, differentiation, and mediator release takes days or weeks, the mast cell degranulation may occur just before any acute coronary event, further resulting in coronary artery vasoconstriction and atheromatous plaque rupture. It seems that medications and natural molecules stabilizing the mast cell membrane as well as monoclonal antibodies protecting the mast cell surface can emerge as novel therapeutic modalities for acute coronary and cerebrovascular event prevention.

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Section: Treatmentmentioning

confidence: 99%

Kounis Syndrome—not a Single-organ Arterial Disorder but a Multisystem and Multidisciplinary Disease

Kounis¹,

Koniari²,

Velissaris³

et al. 2019

Balkan Med J

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“…Details for included publications are outlined in Table 1. [23][24][25][26] We identified 4 RCTs that enrolled critically ill patients, defined as patients admitted to the ICU or presenting to the ED with a medical emergency. All these studies utilized a placebo control, and 3 of the 4 studies uncovered a clinically significant difference in hemodynamics following IV acetaminophen administration.…”

Section: Resultsmentioning

confidence: 99%

“…Another double-blind RCT that enrolled cardiac surgery patients admitted to inpatient surgical services for coronary artery bypass grafting or mitral or aortic valve repair found similar results. 24 Patients (n = 50) were randomized 1:1 to receive 1 dose of 1000 mg IV acetaminophen or 100 mL of placebo before the index procedure, with additional doses at 6 hours, 12 hours, and conclusion of surgery. Following the preoperative dose, there were a total of 14 hypotensive events, defined by the investigators as a ≥20% reduction in SBP from baseline, all of which occurred in the IV acetaminophen group.…”

Section: Resultsmentioning

confidence: 99%

“…First, the definition of clinically relevant hypotension varies widely across studies and may not be generalizable to all practice settings. Some of the more recent studies 23,24 use a standard definition of SBP decline ≥20% from baseline or an absolute value ≤90 mm Hg, which is in line with definitions used to identify conditions such as orthostasis or shock, 43,44 but earlier literature uses arbitrary hemodynamic cutoffs to define hypotension. However, as speculated primarily in the shock literature, many clinicians consider hypotension cutoffs to be a comparative, rather than absolute, and should be considered in relation to the patient at hand.…”

Section: Discussionmentioning

confidence: 99%

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Intravenous Acetaminophen–Induced Hypotension: A Review of the Current Literature

et al. 2019

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Objective: Recent literature suggests that intravenous (IV) administration may cause hypotension in hospitalized patients; data further suggest that this effect is most pronounced in the critically ill. The purpose of this review is to identify and evaluate current literature that addresses the incidence and implications of IV acetaminophen–induced hypotension. Data Sources: A literature search of MEDLINE, Cochrane, and EMBASE databases was performed (2002-2019) using the following terms: acetaminophen, paracetamol, intravenous, and hypotension. Abstracts and peer-reviewed publications were reviewed. Study Selection and Data Extraction: Relevant English-language studies conducted in humans evaluating the hemodynamic effects of IV acetaminophen were considered. Data Synthesis: A majority of the 19 studies included in this review identified a statistically significant drop in hemodynamic variables after the administration of 500 to 1000 mg IV acetaminophen as measured by changes in systolic blood pressure, diastolic blood pressure, or mean arterial pressure. Of the trials reporting vasopressor use, the authors found a significant increase in vasopressor requirements following IV acetaminophen administration. Relevance to Patient Care and Clinical Practice: This review represents the first comprehensive review of IV acetaminophen-induced hypotension. The findings raise the question of whether IV acetaminophen is an appropriate choice for inpatient pain or temperature management in the critically ill. Conclusions: Available evidence indicates that the administration of IV acetaminophen may be harmful in the critically ill. Additional monitoring is likely required when using IV acetaminophen in this specific population, particularly if a patient is hemodynamically unstable prior to administration.

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“…Recent clinical trials have shown that IV paracetamol may cause hypotension in healthy volunteers, the critically ill, and in cardiac surgery patients [ 2 – 5 ]. The hypotensive effects of IV paracetamol appear to be independent of the excipient mannitol (3.9 g), which is included as a stabilization agent in many of the commercially available IV paracetamol formulations.…”

Section: Introductionmentioning

confidence: 99%

The hemodynamic effects of intravenous paracetamol (acetaminophen) in patients with chronic liver disease undergoing liver transplantation: a pilot study

et al. 2021

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Objective We performed a single-center double-blinded, randomized trial to investigate the hemodynamic effects of IV paracetamol in patients with chronic liver disease (CLD) undergoing liver transplantation surgery. Patients with CLD are particularly susceptible to hemodynamic derangements given their low systemic vascular resistance state. Accordingly, hypotension is common in this setting. The hemodynamic effects of IV paracetamol in patients undergoing elective liver transplantation are unknown, therefore we evaluated whether the intraoperative administration of IV paracetamol in patients with chronic liver disease undergoing liver transplantation results in adverse hemodynamic effects. The primary end point was a change in systolic blood pressure 30-min after the preoperative infusion. Results Twenty-four participants undergoing liver transplantation surgery were randomly assigned to receive a single bolus of IV paracetamol (1 g paracetamol + 3.91 g mannitol per 100 mL) (n = 12) or placebo (0.9% Saline 100 mL) (n = 12). All participants completed their study intervention, and there were no breaches or violations of the trial protocol. Baseline characteristics were similar in both groups. There were no significant differences regarding surgical duration, intraoperative use of fluids, and intraoperative noradrenaline use. After the administration of paracetamol there were no significant differences observed in blood pressure or other hemodynamic parameters when compared to placebo.

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The hemodynamic effects of intravenous paracetamol (acetaminophen) vs normal saline in cardiac surgery patients: A single center placebo controlled randomized study

Cited by 15 publications

References 23 publications

Kounis Syndrome—not a Single-organ Arterial Disorder but a Multisystem and Multidisciplinary Disease

Kounis Syndrome—not a Single-organ Arterial Disorder but a Multisystem and Multidisciplinary Disease

Intravenous Acetaminophen–Induced Hypotension: A Review of the Current Literature

The hemodynamic effects of intravenous paracetamol (acetaminophen) in patients with chronic liver disease undergoing liver transplantation: a pilot study

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