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A multicenter, randomized, double-blind, placebo-controlled parallel clinical trial to evaluate the efficacy and safety of ibuprofen injection in the treatment of postoperative acute pain

A multicenter, randomized, double-blind, placebo-controlled parallel clinical trial to evaluate the efficacy and safety of ibuprofen injection in the treatment of postoperative acute pain

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042038
Enrollment
Unknown
Registered
2021-01-12
Start date
2015-05-01
Completion date
Unknown
Last updated
2021-04-12

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

Conditions

Patients with abdominal and orthopedic postoperative pain

Interventions

experimental group:The first intravenous infusion of ibuprofen injection of 0.4g or 0.8mg was started 30min before the end of the operation. Ibuprofen was added to 200ml 0.9% sodium chloride injection
control group:Placebo

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years old men or women; 2. Endoscopic surgery with incision (incision >= 5 cm) and abdominal opening (gallbladder) were performed under general anesthesia at the selected date; General surgery on the capsule, intestine or lower abdomen) or orthopedic surgery, and is expected to require 24 hours postoperatively. Patients with above morphine analgesia; 3. No venous infusion disorder; 4. ASA grade I or II patients; 5. The expected observation and treatment time in hospital or hospital >=24h; 6. Sign the informed consent.

Exclusion criteria

Exclusion criteria: 1) Body weight =140mmHg or diastolic blood pressure >=90 mmHg); 7) Patients who have used non-steroidal anti-inflammatory drugs within 12 hours; 8) Patients with abnormal liver and renal function [SGPT (ALT) or SGOT (AST) were higher than the normal value Limit of 1.5 times; Creatinine is more than 1.5 times the upper limit of normal value or is receiving dialysis treatment within 28 days prior to surgery]; 9) Patients who have used other analgesics, muscle relaxants or sedatives within 24 hours before surgery; 10) Patients with prior dependence on narcotic drugs or tolerance to opioids; 11) Patients who participated in other clinical studies within 3 months before surgery; 12) Patients with other conditions that the researcher considers inappropriate to participate in.

Design outcomes

Primary

MeasureTime frame
Total morphine dosage 24h after operation;

Countries

China

Contacts

Public ContactLiu Jin

West China Hospital, Sichuan University

30333870@qq.com+86 18980605856

Outcome results

None listed

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