Integrated safety analysis of ten Phase II-IV clinical studies

The safety cohort comprised 1,752 adult patients; out of which 1,220 (69.6%) received IV ibuprofen, 452 (25.8%) received placebo and 80 received IV ketorolac

Doses of IV ibuprofen ranged from 100 to 400 mg for the indication of fever and up to 800 mg for pain

A validated 10-point Visual Analog Scale (VAS) was used to evaluate pain

Reasons for pain were both surgical and nonsurgical

Fever was defined as a core body temperature of 38°C (100.4°F) or above

Safety was compared based on the incidence and severity of treatment-emergent AEs as well as changes in vital signs and laboratory parameters

The incidence of at least 1 AE was lower in IV ibuprofen group as compared to placebo (60% vs 85%), with majority of these being mild or moderate

The most common AEs were nausea, vomiting, constipation and flatulence in both groups

Infusion-site pain was the only most frequent AE associated with IV ibuprofen

The incidence of AEs was lower in the ibuprofen group than placebo among elderly patients >65 years (59% vs 94%)

The incidence of markedly abnormal vital signs were similar in both groups

Proportion of patients with SAEs was similar (5% vs 4%)

There was no elevated risk of bleeding event or hematological effect with the administration of IV ibuprofen

IV ibuprofen had similar effects on the renal function as placebo-treated group

IV ibuprofen has been well tolerated by hospitalized and outpatient patients when administered both prior to surgery and postoperatively as well as for nonsurgical pain or fever. 

Intravenous ibuprofen demonstrated a favorable safety profile, with lesser adverse events and require less morphine as compared to those receiving placebo

IV ibuprofen can be safely administered prior to surgery and continued in the postoperative period as a component of multimodal pain management in hospitalized adults.