Evaluation of the effect of tizanidine administration on acute pain control after CABG in adult patients: A randomized placebo-controlled clinical trial

In this study, we will investigate the effect of tizanidine on acute pain control after coronary artery bypass graft (CABG) surgery in adult patients admitted to Imam Reza Hospital.

This phase 3 double-blind clinical trial will be performed on 60 adult patients. The random number table method will be used to randomize and divide patients into two groups of intervention and control.

This clinical trial will be performed in the intensive care unit of Imam Reza Hospital. An equal number of patients will be admitted to the intervention and control groups by simple randomization. In this study, participants, researchers, clinical caregivers, and data analysts were considered blind. Another expert who is not involved in prescribing, evaluating treatment, or analyzing data, will assign patients to study groups.

Admission requirements: Patients admitted to CABG surgery in the age range of 18 to 65 years receiving standard medication regimen Signing the informed consent form by the patient Conditions for not entering the study: Severe renal failure (CrCl <25 ml/min) History of drug or alcohol addiction Low arterial blood pressure (SBP <90 mmHg or MAP <65 mmHg) Concomitant use of dexmedetomidine Taking painkillers 24 hours before surgery

Patients admitted to the intervention group receive one 4 mg tizanidine tablet immediately before surgery and then twice daily until the end of the second day after surgery. In the control group, patients receive a placebo tablet that looked exactly like the original drug immediately before surgery and then instructed twice a day until the end of the second day after surgery.

The severity of postoperative pain with the use of Numerical Rating Scale

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.

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.