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Effects of an intravenous acetaminophen/ibuprofen fixed-dose combination on catheter- related bladder discomfort: a prospective, randomized, placebo-controlled, double-blind study

Effects of an intravenous acetaminophen/ibuprofen fixed-dose combination on catheter- related bladder discomfort: a prospective, randomized, placebo-controlled, double-blind study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0007640
Enrollment
106
Registered
2022-08-09
Start date
2022-12-29
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

None listed

Interventions

Drug : 30 minutes before the end of the expected surgery, the maxigesic group receives 1 vial (100 mL) of the maxigesic formula and the control group receives 100 mL of normal saline over 15 minutes.

Sponsors

Konyang University Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Male patients aged 19 to 70 who require catheterization in the operating room during urology surgery 2. According to the American Society of Anesthesiologist's physical status classification, 1 to 3 patients.

Exclusion criteria

Exclusion criteria: -Benign prostatic hyperplasia - Patients with overactive bladder symptoms (frequent urination 3 or more times at night or 8 or more times in 24 hours) - Patients with bladder outlet and lower urinary tract obstruction - Psychiatric patients - Patients with cognitive impairment - Contraindicated use of acetaminophen or ibuprofen (e.g., history of hypersensitivity reactions, gastrointestinal ulcers, severe renal impairment) - Patients with active alcoholism - Patients with severe blood abnormalities, liver disorders, kidney disorders, heart failure, and high blood pressure - Patients with bronchial asthma or a history - Patients with pain before and after coronary artery bypass surgery - If patients are taking concomitant medications (eg, barbiturates, tricyclic antidepressants, high-dose methotrexate) - In other cases where the researcher is considered inappropriate

Design outcomes

Primary

MeasureTime frame
catheter related bladder discomfort

Secondary

MeasureTime frame
Time to extubation, sedation level, pain level, emergence agitation, requirement of analgesic, requirement of antiemetic, and other discomfort complained by the patient after surgery, catheter related bladder discomfort in the ward

Countries

Korea, Republic of

Contacts

Public ContactSung-Ae Cho

Konyang University Hospital

sachosa@naver.com+82-42-600-9301

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: May 7, 2026