Conditions: Pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 319
Healthy volunteers: no

Brief 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

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Normal saline as placebo comparator intervention 2: Intravenous ibuprofen
Intervention descriptions: intervention 1: 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) intervention 2: 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)

Protocol document: