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 | Unknown Phase 3 DMC

• 1 other identifier: 2017PHA019
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• the amount of morphine administered

  after surgery.

  during the first 24 hours

Secondary Outcomes (5)

• Pain intensity (PI)

  at 0 hour,1 hour, 2 hours, 3 hours, 6 hours, 12 hours, 18 hours, 24 hours, 30 hours, 36 hours, 42 hours and 48 hours immediately after the first administration.

• The area under the PI-time curve (AUC)

  across 3 time periods (1-24 hours, 6-24 hours, 12-24 hours)

• Total frequency and effective frequency of PCA

  within 24 hours

• Treatment failure rate

  within 24 hours after the operation

• Patients' evaluation of the study drug

  after 48 hours of medication

Study Arms (3)

ibuprofen( 400mg group)

EXPERIMENTAL

Patients were randomly divided into the group received respectively IV ibuprofen 400 mg .

Drug: ibuprofen

ibuprofen( 800mg group)

EXPERIMENTAL

Patients were randomly divided into the group received respectively IV ibuprofen 800 mg.

Drug: ibuprofen

placebo group

PLACEBO COMPARATOR

Patients were randomly divided into the group received respectively IV placebo,.

Drug: Placebo

Interventions

ibuprofen DRUG

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.

ibuprofen( 400mg group); ibuprofen( 800mg group)

Placebo DRUG

Placebo

placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Enrollment was open to patients undergoing scheduled abdominal surgery (intestinal or lower abdomen) or orthopedic surgery (such as knee arthroplasty or shoulder joint reconstruction) under general anesthesia with endotracheal intubation and were expected to require patient-controlled intravenous analgesia (PCIA) pump for more than 24h for moderate to severe pain after surgery.

You may not qualify if:

• Those who can not understand the NRS score and cooperate with the evaluation; those who had head trauma or complicated with organic lesions of the central nervous system within 4 weeks before operation; those who developed coagulation dysfunction or took anticoagulants and antiplatelet drugs; those with a history of severe cardio-cerebrovascular disease, heart failure; those with liver and kidney dysfunction, severe endocrine system diseases, mental illness; those with a history of peptic ulcer or bleeding; those who did not control grade 2 or above hypertension or were still taking two or more of antihypertensive drugs such as angiotensin converting enzyme inhibitors (ACEI), angiotensin converting enzyme antagonists (ARB) and diuretics at admission; Increased toxicity due to the interaction of methotrexate, lithium preparations, etc. with the test drug; use of NSAIDs or analgesic muscle relaxants within 24 hours before operation, narcotic dependence or tolerance; allergy to ibuprofen or other NSAIDs; pregnant or lactating women

Sponsors & Collaborators

• Yi Feng, MD: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Yi Feng, MD

  Peking University People's Hospital

  STUDY CHAIR

Central Study Contacts

Yi Feng, MD

CONTACT

08601088325590; yifeng65@sina.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of department of anesthesiology and painmanagement

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: June 12, 2020
• Study Start: June 10, 2020
• Primary Completion: June 10, 2020
• Study Completion: June 10, 2020
• Last Updated: June 19, 2020

Record last verified: 2020-06

Locations

CN (1)