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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Intravenous Ibuprofen 400 and 800 mg Every 6 Hours in the Management of Postoperative Pain.

NCT04429282 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 396

Last updated 2020-06-19

No results posted yet for this study

Summary

This study was to evaluate the efficacy and safety of intravenously administered ibuprofen 400mg and 800 mg q6h for the management of moderate to severe postoperative pain in Chinese population.

Conditions

  • Ibuprofen
  • Nonsteroidal Anti-inflammatory Drug
  • Intravenous
  • Injectable
  • Pain
  • Analgesic

Interventions

DRUG

ibuprofen

Patients were randomly divided into three groups in radio 1:1:1 received respectively IV placebo, ibuprofen 400 mg or ibuprofen 800 mg. The first dose of study drugs was administered intravenously at the time of wound closure and then every 6 hours within 48 hours after the operation.

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Yi Feng, MD

    lead OTHER

Principal Investigators

  • Yi Feng, MD · Peking University People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-10
Primary Completion
2020-06-10
Completion
2020-06-10

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04429282 on ClinicalTrials.gov