None listed
Conditions
Interventions
None listed
Sponsors
Inje University Sanggye Paik Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: - Outpatients undergoing hysteroscopy under general anesthesia at our hospital -Adult female patients between the ages of 18 and 65 who agreed to participate in the study -BMI < 30 kg/m2 -ASA Physical Status Classification 1 or 2
Exclusion criteria
Exclusion criteria: ? A history of allergic reaction or clinically significant hypersensitivity to acetaminophen, aspirin, opioids, or any non-steroidal anti-inflammatory drug (NSAID, including ibuprofen). history of NSAID-induced bronchospasm (subjects with triad of asthma, nasal polyps, and chronic rhinitis are at greater risk of bronchospasm and should be carefully considered); or hypersensitivity, allergy, or serious reaction to any other drug used in the study, including sulfa (including sulfonamides) medicines, ingredients of the study drug, or anesthetics and antibiotics that may be needed on the day of surgery ? Patients who have taken the following drugs: barbiturates, tricyclic antidepressants ? When participating in the study, experiencing any surgical complications or other problems that may compromise the safety of the subjects or confuse the results of the study ? Known or suspected history of alcoholism or substance abuse or misuse within the last 2 years, or evidence of tolerance or physical dependence prior to administration of study drug ? Have a clinically significant unstable cardiac, respiratory, neurological, immune, blood, or kidney disease or other condition that, in the judgment of the researcher, could impair the subject's well-being, ability to communicate with research staff, or otherwise preclude participation in the study Occation ? History of or current diagnosis of a serious mental disorder that would affect the subject's ability to comply with the study requirements. ? In case of positive reaction in urine drug test or alcohol breathalyzer test ? If there is a history of clinically significant gastrointestinal event within 6 months prior to screening, or a history of peptic or gastric ulcer or intestinal bleeding ? Surgical or medical conditions of the gastrointestinal tract or renal system that can significantly alter the absorption, distribution or excretion of a drug component. ? If the researcher judges that the researcher is not suitable for receiving the study drug for any reason ? Receiving systemic chemotherapy, having active malignancy of any type, or having been diagnosed with cancer within 5 years prior to screening (except for treated squamous or basal cell carcinoma of the skin) ? If you are currently receiving anticoagulants (e.g. heparin or warfarin) ? Those who have received a course of systemic corticosteroids (oral or parenteral) within 3 months prior to screening (topical/limited application of inhaled nasal steroids and topical corticosteroids (at the investigator's discretion) is permitted) ? History of chronic use (defined as daily use for >2 weeks) of NSAIDs, opioids, or glucocorticoids (excluding inhaled nasal steroids and topical/restricted topical corticosteroids) for any condition within 6 months prior to study drug administration Inclusion, if any, is determined by the researcher. ? Significant renal or liver disease in clinical laboratory evaluation (for all liver function tests including AST, ALT, the result is 3 times the upper limit of normal [ULN] or more, or Cr is 1.5 times the upper limit of normal or more. 16 If you have previously participated in another clinical study of Maxigesic® IV or received an investigational drug or device or investigational therapy within 30 days before screening, if there are significant results of other screening tests, the investigator decides whether to participate or not.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative pain intensity | — |
Secondary
| Measure | Time frame |
|---|---|
| Use of auxiliary pain medications, nausea and vomiting after surgery, time to leave the recovery room | — |
Countries
Korea, Republic of
Contacts
Public ContactSangseok Lee
Inje University Sanggye Paik Hospital
Outcome results
None listed