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1.
Trials ; 23(1): 1016, 2022 Dec 15.
Article in English | MEDLINE | ID: mdl-36522767

ABSTRACT

BACKGROUND: In emergency medicine, pain is a frequent reason for consultation. However, there is a great variation in its management which is often insufficient. The use intravenous morphine alone or multimodal analgesia with paracetamol is recommended for severe pain. But robust data are lacking to justify the association of paracetamol with morphine versus morphine alone for pain management in the emergency room (ER). The aim of our study is therefore to assess if in patients with acute pain of moderate to severe intensity with a numerical verbal scale (NVS) ≥5 in the ER, the intravenous administration of morphine alone is not inferior to the administration of intravenous morphine combined with paracetamol at 30 min from the first administration of the study drug. METHODS: ADAMOPA is a prospective, non-inferiority, multicenter, placebo-controlled, parallel-group, randomized (1:1), double-blind trial. Subjects will be enrolled in the ER if they experience moderate to severe, acute, non-traumatic, and traumatic pain, defined as an NVS ≥5. The primary endpoint will be the between-group difference in mean change in NVS pain scores among patients receiving the combination of intravenous morphine plus paracetamol or intravenous morphine given alone, measured from the time before administration of the study medication to 30 min later. DISCUSSION: This trial will determine the clinical utility of the association of paracetamol with morphine for pain management in the emergency room. The ADAMOPA trial will be conducted in accordance with the International Council on Harmonization Good Clinical Practices. TRIAL REGISTRATION: EudraCT number: 2019-002149-39. CLINICALTRIALS: gov identifier: NCT04148495. Date of trial registration: November 1, 2019.


Subject(s)
Acute Pain , Morphine , Humans , Morphine/adverse effects , Acetaminophen , Acute Pain/diagnosis , Acute Pain/drug therapy , Prospective Studies , Analgesics, Opioid , Treatment Outcome , Double-Blind Method , Administration, Intravenous , Emergency Service, Hospital , Randomized Controlled Trials as Topic , Multicenter Studies as Topic
2.
BMC Emerg Med ; 21(1): 141, 2021 11 19.
Article in English | MEDLINE | ID: mdl-34798827

ABSTRACT

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) can be associated with myocardial injury. Identification of at-risk patients and mechanisms underlying cardiac involvement in COVID-19 remains unclear. During hospitalization for COVID-19, high troponin level has been found to be an independent variable associated with in-hospital mortality and a greater risk of complications. Electrocardiographic (ECG) abnormalities could be a useful tool to identify patients at risk of poor prognostic. The aim of our study was to assess if specific ECGs patterns could be related with in-hospital mortality in COVID-19 patients presenting to the ED in a European country. METHODS: From February 1st to May 31st, 2020, we conducted a multicenter study in three hospitals in France. We included adult patients (≥ 18 years old) who visited the ED during the study period, with ECG performed at ED admission and diagnosed with COVID-19. Demographic, comorbidities, drug exposures, signs and symptoms presented, and outcome data were extracted from electronic medical records using a standardized data collection form. The relationship between ECG abnormalities and in-hospital mortality was assessed using univariate and multivariable logistic regression analyses. RESULTS: An ECG was performed on 275 patients who presented to the ED. Most of the ECGs were in normal sinus rhythm (87%), and 26 (10%) patients had atrial fibrillation/flutter on ECG at ED admission. Repolarization abnormalities represented the most common findings reported in the population (40%), with negative T waves representing 21% of all abnormalities. We found that abnormal axis (adjusted odds ratio: 3.9 [95% CI, 1.1-11.5], p = 0.02), and left bundle branch block (adjusted odds ratio: 7.1 [95% CI, 1.9-25.1], p = 0.002) were significantly associated with in-hospital mortality. CONCLUSIONS: ECG performed at ED admission may be useful to predict death in COVID-19 patients. Our data suggest that the presence of abnormal axis and left bundle branch block on ECG indicated a higher risk of in-hospital mortality in COVID-19 patients who presented to the ED. We also confirmed that ST segment elevation was rare in COVID-19 patients.


Subject(s)
COVID-19 , Adolescent , Adult , Electrocardiography , Emergency Service, Hospital , Humans , Retrospective Studies , SARS-CoV-2
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