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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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20201220049774N1
Enrollment
60
Registered
2020-12-28
Start date
2021-02-13
Completion date
Unknown
Last updated
2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease. Chapter IX / Diseases of the circulatory system (100-199) / 120 Angina pectoris/ 121 Acute myocardial infarction

Interventions

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 s

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHesamoddin Hosseinjani

Mashhad University of Medical Sciences

hosseinjanih@mums.ac.ir+98 51 3180 1586

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026