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IRCT201405133954N7 IRCT 2015-04-26 Vice chancellor for research Hamehan University of Medical Sciences Intravenous Acetaminophen analgesic effects and improvement of cardiac function in myocardial infarction The role of intravenous Acetaminophen versus intravenous Morphine sulfate in pain management and improvement of cardiac function in post acute MI patients who admitted to Hamadan Ekbatan Hospital 2014-09-23 anticipated 70 Complete https://irct.ir/trial/4141 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2-3 Condition 1: Acute myocardial infarction. Condition 2: Analgesia. Intervention 1: All patients will receive initial treatment of myocardial infarction in arrival emergency department.The treatment consists of oxygen by nasal, oral aspirin 325 mg, sublingual nitrate for up to 3 doses and initial dose of intravenous morphine 3 mg . The intervention group will receive 4 doses of acetaminophen 1 gram intravenously every 6 hours, dissolved in 100 mL of normal saline. Methods: 70 pack of dark colors written on them from 1 to 70 are randomly divided into two groups of 35.Inside each envelope is a card on which the letters A (acetaminophen treatment group) or the letter B (morphine treatment group) is written.The letter A or B can be placed inside the envelope are determined using a random numbers table.The first patient to be admitted, we're open Envelope 1 , and patients indicates that the card is inserted into envelopes .Similarly, during the study,for each patient who is eligible for inclusion special envelopes will be opened by the numbers and them placed in the specified group.Pain score using Visual Analogue Scale for0, 0.5, 1, 2, 4, 6, 12, 18 and 24 hours after MI is measured. Also in 0 , 0.5 , 1, 2, 4, 6, 12, 18 and 24 hours post-MI patients' blood pressure and heart rate will be measured . All patients underwent echocardiography 3 days and 6 weeks after MI then ischemic complications involving Hypokinesia, Akinesia and Dyskinesia and Ejection Fraction will be measure by Simpson technique . Intervention 2: In the control group if there is pain, will prescribe Morphine Sulfate 3 mg IV every 6 hours. Pain score using Visual Analogue Scale for 0.5, 1, 2, 4, 6, 12, 18 and 24 hours after MI is measured. Also in 0.5 , 1, 2, 4, 6, 12, 18 and 24 hours post-MI patients' blood pressure and heart rate will be measured . All patients underwent echocardiography 3 days and 6 weeks after MI then ischemic complications involving Hypokinesia, Akinesia and Dyskinesia and Ejection Fraction will be measure by Simpson technique .
public Behzad Roozbahani MD
Ekbatan Hospital- Hamadan-Iran
Hamedan Iran (Islamic Republic of) +98 81 3825 1244 behzadroozbahani@gmail.com Hamedan university of medical science scientific Bakhshaei shahrbabaki Mohammad Hossein MD
Operating room Teather- Ekbatan Hospital- Hamadan
Hamedan Iran (Islamic Republic of) +98 81382512445 bakhshaei@umsha.ac.ir Hamehan University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: 40-80 years old patients ؛ who admitted to Hamedan Ekbatan hospital with using signs and ECG for the detection of myocardial infarction . Exclusion criteria: systolic blood pressure less than 100 mm Hg or greater than 200 mm Hg ؛ diastolic blood pressure below 60 mm Hg ؛ history of previous myocardial infarction ؛ fibrinolytic therapy or revascularization ؛ hepatic and renal disease ؛ addiction to Opium consumption ؛ VAS(Visual Analogue Scale) greater than 3 ؛ loss of consciousness. 40 years 80 years Both I 21 , I 2 R00 , R01 Acute myocardial infarction Incl.:myocardial infarction specified as acute or with a stated duration of 4 weeks (28 days) or less from onsetExcl.:certain current complications following acute myocardial infarction (I23.-) myocardial infarction:•old (I25. Cardiac murmurs and other cardiac sounds ؛ Abnormalities of heart beat ؛ Pain in throat and chest ؛ Other symptoms and signs involving the circulatory and respiratory systems ؛ Treatment - Drugs Treatment - Drugs All patients will receive initial treatment of myocardial infarction in arrival emergency department.The treatment consists of oxygen by nasal, oral aspirin 325 mg, sublingual nitrate for up to 3 doses and initial dose of intravenous morphine 3 mg . The intervention group will receive 4 doses of acetaminophen 1 gram intravenously every 6 hours, dissolved in 100 mL of normal saline. Methods: 70 pack of dark colors written on them from 1 to 70 are randomly divided into two groups of 35.Inside each envelope is a card on which the letters A (acetaminophen treatment group) or the letter B (morphine treatment group) is written.The letter A or B can be placed inside the envelope are determined using a random numbers table.The first patient to be admitted, we're open Envelope 1 , and patients indicates that the card is inserted into envelopes .Similarly, during the study,for each patient who is eligible for inclusion special envelopes will be opened by the numbers and them placed in the specified group.Pain score using Visual Analogue Scale for0, 0.5, 1, 2, 4, 6, 12, 18 and 24 hours after MI is measured. Also in 0 , 0.5 , 1, 2, 4, 6, 12, 18 and 24 hours post-MI patients' blood pressure and heart rate will be measured . All patients underwent echocardiography 3 days and 6 weeks after MI then ischemic complications involving Hypokinesia, Akinesia and Dyskinesia and Ejection Fraction will be measure by Simpson technique . In the control group if there is pain, will prescribe Morphine Sulfate 3 mg IV every 6 hours. Pain score using Visual Analogue Scale for 0.5, 1, 2, 4, 6, 12, 18 and 24 hours after MI is measured. Also in 0.5 , 1, 2, 4, 6, 12, 18 and 24 hours post-MI patients' blood pressure and heart rate will be measured . All patients underwent echocardiography 3 days and 6 weeks after MI then ischemic complications involving Hypokinesia, Akinesia and Dyskinesia and Ejection Fraction will be measure by Simpson technique . Myocardial infarction pain. Timepoint: 0,0.5,1,2,4,6,12,18,24 hours after myocardial infarction. Method of measurement: Visual Analogue Scale. Heart rate. Timepoint: 0,0.5,1,2,4,6,12,18,24 hours after myocardial infarction. Method of measurement: Holter monitoring. Arterial blood pressure. Timepoint: 0,0.5,1,2,4,6,12,18,24 hours after myocardial infarction. Method of measurement: Holter monitoring. Cardiac function. Timepoint: 3rd and 42th days after myocardial infarction. Method of measurement: by Echocardiograghy. Vice chancellor for research Hamehan University of Medical Sciences Approved 2014-06-25 Ethics Committee of Hamehan University of Medical Sciences University of Medical Sciences,Shahid Fahmideh boulevard Hamedan Iran (Islamic Republic of)