None listed
Conditions
Interventions
Drug :
- Product name: Maxigesic® IV
- ingredients: Acetaminophen 1,000 mg + Ibuprofen 300 mg (1 vial / 100 mL)
- Administration method: Maxigesic® IV will be administered intravenously without dilut
Sponsors
Ajou University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Adults aged 19 years or older 2.Patients scheduled to undergo cardiovascular surgery, including cardiac valve surgery or aortic surgery 3.Patients with New York Heart Association (NYHA) functional class I-III (capable of normal daily activities) 4.Patients who provide written informed consent to participate in this clinical study
Exclusion criteria
Exclusion criteria: 1.Patients with hypersensitivity to the active ingredients, excipients, aspirin, or other non-steroidal anti-inflammatory drugs (NSAIDs) 2.Patients diagnosed with moderate to severe Alcohol Use Disorder per DSM-5 criteria, currently receiving treatment, or who have received treatment or diagnosis for alcohol use disorder within the past 6 months 3.Patients with gastrointestinal ulcer, gastrointestinal bleeding, or history 4. Patients with currently treated or uncontrolled bronchial asthma 5.Patients with severe hematologic abnormalities or severe hepatic impairment, defined as: PLT 2.5 × ULN, ALT > 2.5 × ULN, ALP > 2.5 × ULN Total Bilirubin > 1.5 × ULN Cr > 1.5 × ULN 6.Patients with impaired renal function (eGFR < 30 mL/min/1.73 m² per CKD-EPI Creatinine Equation, 2021) 7.Patients taking barbiturates or tricyclic antidepressants 8.Pregnant or lactating women 9.Any subjects deemed unsuitable for study participation by the investigator's judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Summed Pain Intensity Difference (SPID24) over 24 hours post-surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Korean version of Quality of Recovery-15 (QoR-15K) scores measured preoperatively and at 24, 48 hours postoperatively;Summed Pain Intensity Difference (SPID48, SPID72): Total summed difference in pain intensity at rest and during coughing, assessed using Visual Analogue Scale (VAS) at 48 and 72 hours post-surgery;Total number of doses and cumulative dosage of rescue medications(1.Nefopam Hydrochloride 10 mg, 2.Tramadol Hydrochloride 50mg) administered up to 72 hours post-surgery;Chronic pain assessment at 3 months post-surgery: pain location, characteristics, frequency and dosage of prescribed analgesics and adjuvant medications;Incidence of adverse events within 48 hours post-surgery, including nausea, vomiting, hypotension, and respiratory depression;Cumulative dosage of control and study drugs administered up to 72 hours post-surgery | — |
Countries
Korea, Republic of
Contacts
Public ContactDo Jung Kim
Ajou University Hospital
Outcome results
None listed