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A domestic multi-center, real-world study to evaluate the safety and efficacy of acetaminophen mannitol injection in the treatment of postoperation pain

A domestic multi-center, real-world study to evaluate the safety and efficacy of acetaminophen mannitol injection in the treatment of postoperation pain

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400083769
Enrollment
Unknown
Registered
2024-04-30
Start date
2024-05-01
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

postoperation pain

Interventions

Treatment group (acetaminophen mannitol injection):None

Sponsors

The First Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who developed postoperative pain and were treated with acetaminophen and mannitol injection were selected in the retrospective cohort. Complete medical records before and after treatment were required, including demographics, past medical history, laboratory tests, concomitant medications, and adverse events. Prospective team inclusion criteria: 1. Age and gender are not limited; 2. Patients who were scheduled for elective surgery and expected to have postoperative pain and were treated with acetaminophen and mannitol injection; 3. Informed consent was obtained from patients voluntarily.

Exclusion criteria

Exclusion criteria: 1. Patients with known allergy to acetaminophen or any component of intravenous fluids; (2) patients with a history of chronic hepatitis, cirrhosis, and abnormal liver function (AST and/or ALT=2×ULN); 3. Patients deemed by the investigator to be ineligible for enrollment.

Design outcomes

Primary

MeasureTime frame
Incidence of adverse events (aes) and serious adverse events (SAEs).;Total opioid consumption within 24, 48, and 72h after administration of the first study drug;

Secondary

MeasureTime frame
Changes in laboratory test results;Incidence of opioid-related adverse events within 24h after the first dose;Pain intensity scores 0-24h, 24-48h, and 48-72h after the first study drug administration;Paracetamol and mannitol injection exposure, vital signs and combined medication information of patients, etc;

Countries

China

Contacts

Public ContactZhang Bin

The First Affiliated Hospital of Nanchang University

609901889@qq.com+86 139 7082 3907

Outcome results

None listed

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