At a glance
ClinicalIndex Comparison Record- ✓Scheduled for elective abdominal hysterectomy with anticipated need for post-operative IV morphine analgesia for ≥24 hours
- ✓Age 18-70 years
- ✓Adequate IV access
- ✓Anticipated hospital stay ≥24 hours
- ✕Use of NSAIDs within 12 hours prior to dosing
- ✕Use of analgesics, muscle relaxants, or sedatives within 24 hours prior to treatment, with specified exceptions
- ✕Taking warfarin, lithium, or combination of ACE-inhibitors and furosemide
- ✕History of allergy or hypersensitivity to ibuprofen, aspirin, NSAIDs, or COX-2 inhibitors
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial of Ibuprofen Injection (IVIb) for Treatment of Pain in the Post-Operative Adult Patients
In Brief
A Phase 3 clinical trial evaluating Normal saline as placebo comparator and Intravenous ibuprofen for Pain. Completed, enrolled 319 participants across 13 sites in 2 countries.
Detailed Summary
The primary objective of this study of Caldolor (IV ibuprofen) administered to post-operative hospitalized adult patients every 6 hours for 48 hours is to determine the efficacy of Caldolor compared to placebo for the treatment of post-operative pain as measured by reduction in the requirement for the narcotic analgesic, morphine, post surgery
Study Details
Timeline
Interventions
250 ml normal saline as a placebo comparator was administered every 6 hours for a total of eight doses over the first 48 hours. Those patients who received the initial eight doses could continue to receive additional doses as needed through the end of the treatment period (day 5)
800 mg intravenous ibuprofen diluted in 250 milliliters of normal saline was administered every 6 hours for a total of eight doses over the first 48 hours. Those patients who received the initial eight doses could continue to receive additional doses as needed through the end of the treatment period (day 5)