]>
IRCT20201220049774N1 IRCT 2020-12-28 Mashhad University of Medical Sciences Effect of tizanidine on pain after cardiac surgery Evaluation of the effect of tizanidine administration on acute pain control after CABG in adult patients: A randomized placebo-controlled clinical trial 2021-02-13 anticipated 60 Complete https://irct.ir/trial/53116 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random number table method will be used for simple randomization and division of patients into two groups of intervention and control and determining the type of drug received (drug or placebo). The table for assigning each code to each patient is provided for the expert in the center for prescribing and rational use of drugs in Imam Reza (AS) Hospital. It should be noted that the expert is fully aware of the type of code (Knows what medication each patient has received. Also, medications are given to him or her based on the number (A or B), and he or she is fully aware of which code is related to drug or placebo). The expert is not involved in prescribing or evaluating the treatment or analyzing the data and is solely responsible for maintaining the codes and assigning patients to one of the relevant codes. Adult patients who are candidates for CABG surgery are randomly assigned to one of the groups by the expert according to the codes set. The drug or placebo tablets are then given to the researcher who is unaware of codes and the content of tablets, Blinding description: In this study, the participants, the lead researcher in charge of data collection and outcome assessment, clinical caregivers, including physicians and nurses, and data analysts, were considered blind to the study groups. 3 Coronary Artery Disease. Intervention 1: Intervention group: Patients admitted to the intervention group take one 4 mg tizanidine tablet with 30 to 50 cc of water immediately before surgery. After the admission of post CABG surgery patients to the intensive care unit, tizanidine tablets are prescribed to patients at a dose of 4 mg twice a day until the end of the second day after surgery. Intervention 2: Control group: Patients in the control group, take a placebo tablet that looked exactly like the original drug with 30 to 50 cc of water immediately before surgery. After the admission of post CABG surgery patients to the intensive care unit, placebo tablets are prescribed to patients at a dose of 4 mg twice a day until the end of the second day after surgery. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Hesamoddin Hosseinjani
Department of Clinical Pharmacy, Faculty of Pharmacy, Ferdowsi University Campus, Azadi Square, Mashhad
Mashhad Iran (Islamic Republic of) 9177948954 +98 51 3180 1586 hosseinjanih@mums.ac.ir Mashhad University of Medical Sciences scientific Hesamoddin Hosseinjani
Department of Clinical Pharmacy, Faculty of Pharmacy, Ferdowsi University Campus, Azadi Square, Mashhad
Mashhad Iran (Islamic Republic of) 9177948954 +98 51 3180 1586 hosseinjanih@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients hospitalized for CABG surgery in the age range of 18 to 65 years receiving standard medication regimen (Aspirin, P2Y12 platelet receptor blockers, angiotensin-converting enzyme inhibitors, beta-blockers, and statins) Signing the informed consent form by the patient 18 years 65 years Both severe renal failure (CrCl <25 ml/min) Severe hepatic impairment (patients with class C hepatic impairment based on Child-Pugh classification with a score of 10-15 based on the parameters of ascites, bilirubin, albumin, INR and encephalopathy) History of hypersensitivity reactions to tizanidine History of drug or alcohol addiction Low arterial blood pressure (SBP <90 mmHg or MAP <65 mmHg) Concomitant use of dexmedetomidine Chronic pain Taking painkillers 24 hours before surgery Neuromuscular disease Class IV (severe) heart failure according to the New York Heart Association classification Receiving ciprofloxacin during hospitalization Pregnancy or breastfeeding 120/ 121 Chapter IX / Diseases of the circulatory system (100-199) / 120 Angina pectoris/ 121 Acute myocardial infarction Treatment - Drugs Treatment - Drugs Intervention group: Patients admitted to the intervention group take one 4 mg tizanidine tablet with 30 to 50 cc of water immediately before surgery. After the admission of post CABG surgery patients to the intensive care unit, tizanidine tablets are prescribed to patients at a dose of 4 mg twice a day until the end of the second day after surgery. Control group: Patients in the control group, take a placebo tablet that looked exactly like the original drug with 30 to 50 cc of water immediately before surgery. After the admission of post CABG surgery patients to the intensive care unit, placebo tablets are prescribed to patients at a dose of 4 mg twice a day until the end of the second day after surgery. The severity of postoperative pain with the use of Numerical Rating Scale. Timepoint: The severity of postoperative pain is measured in the intensive care unit after the end of surgery and on days first and second postoperative, two hours after the administration of 4 mg tizanidine tablet. Method of measurement: Numerical Rating Scale. Systolic blood pressure and mean arterial pressure. Timepoint: It is measured before surgery, during surgery, and after the patient enters the intensive care unit and in the first and second days after surgery twice in two hours after administration of 4 mg tizanidine tablets. Method of measurement: Cardiac monitoring device. Heart rate. Timepoint: It is measured before surgery, during surgery, and after the patient enters the intensive care unit and in the first and second days after surgery twice in two hours after administration of 4 mg tizanidine tablets. Method of measurement: Cardiac monitoring device. Drowsiness. Timepoint: It is measured before surgery, and after the patient enters the intensive care unit and in the first and second days after surgery twice in two hours after administration of 4 mg tizanidine tablets. Method of measurement: Kulka four-level criterion. Dry mouth. Timepoint: It is measured before surgery, and after the patient enters the intensive care unit and in the first and second days after surgery twice in two hours after administration of 4 mg tizanidine tablets. Method of measurement: Question from the patient. Total amount of narcotic drug used. Timepoint: It is calculated during the patient monitoring from the end of surgery to the end of the second day after surgery. Method of measurement: Patient nursing care cardex. Time of administration of the first dose of narcotic analgesic after surgery in the intensive care unit. Timepoint: Calculated in minutes from the time of completion of surgery. Method of measurement: Patient nursing care cardex. Total number of times of prescribing fixed-dose narcotic analgesic. Timepoint: It is calculated during the patient monitoring from the end of surgery to the end of the second day after surgery. Method of measurement: Patient nursing care cardex. Mashhad University of Medical Sciences Approved 2020-12-19 Research Ethics Committee of Mashhad University of Medical Sciences Department of Clinical Pharmacy, Faculty of Pharmacy, Ferdowsi University Campus, Azadi Square Mashhad Razavi Khorasan Iran (Islamic Republic of)