Dose Ranging Pain Study4
Study Description
A multi-center, randomized, double-blind, placebo-controlled dose–ranging trial evaluating the safety and analgesic efficacy of IV ibuprofen vs. placebo in 406 patients undergoing orthopedic or abdominal surgery.
Study Results
In this dose ranging study using CALDOLOR (IV Ibuprofen) in patients undergoing elective, single site orthopedic or abdominal surgery, IV Ibuprofen 400 mg and 800 mg was administered intra-operatively at surgical closure and every 6 hours post-operatively. The treatment and placebo groups also had open access to morphine. Results showed a significant morphine sparing effect and a significant reduction in pain at rest and with movement with the 800 mg dose of IV Ibuprofen as measured by Visual Analog Scale (VAS) compared to placebo patients.
Morphine Use
- Study demonstrated a 2.8% reduction in median morphine use with 400 mg of IV Ibuprofen
in the first 24 hours after use. - Study demonstrated a 22.0% reduction in median morphine use with 800 mg of IV Ibuprofen
in the first 24 hours after use.
VAS assessed at rest and with movement with 400 mg and 800 mg over the immediate 24 hours following surgery:
- There was a 6.8% reduction in VAS scores at rest over the immediate 24 hours after surgery for the 400 mg IV Ibuprofen treatment group (p= 0.057).
- There was a 9.4% reduction in VAS scores with movement over the immediate 24 hours after surgery for the 400 mg IV Ibuprofen treatment group (p=0.051).
- There was a 20% reduction in VAS scores at rest over the immediate 24 hours after surgery for the 800 mg IV Ibuprofen treatment group (p= 0.001).
- There was a 33% reduction in VAS scores at rest for hour 24 after surgery for the 800 mg IV Ibuprofen treatment group (p= 0.009).
- There was a 14% reduction in VAS scores with movement over the immediate 24 hours after surgery for the 800 mg IV Ibuprofen treatment group (p= 0.002).
- There was a 18% reduction in VAS scores with movement for hour 24 after surgery for the 800 mg IV Ibuprofen treatment group (p= 0.005).
- The most common adverse events reported in this study were nausea, vomiting, constipation and headache.
CALDOLOR in vials must be diluted prior to use. Infusion of the drug product in the vial without dilution can cause hemolysis. CALDOLOR in the vial should not be given as an IV bolus or IM injection.1
CALDOLOR is also available in a ready-to-use bag that requires no dilution prior to use. 1
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS1
Cardiovascular Thrombotic Events
- Non-steroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
- CALDOLOR is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
- NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
INDICATIONS AND USAGE1
CALDOLOR is indicated in adults and pediatric patients three months and older for the:
- Management of mild to moderate pain and the management of moderate to severe pain as an adjunct to opioid analgesics
- Reduction of fever
IMPORTANT DOSAGE AND ADMINISTRATION INSTRUCTIONS1
CALDOLOR Injection 800 mg/8 mL (100 mg/mL) vials must be diluted prior to administration.
CALDOLOR Injection 800 mg/200 mL (4 mg/mL) bags are ready to use and require no dilution prior to use.
Do not exceed 3,200 mg total daily dose in adults. Do not exceed 40 mg/kg or 2,400 mg, whichever is less, total daily dose in pediatric patients less than 17 years of age. In pediatric patients 3 months to less than 6 months of age, the dosage is limited to a single dose not to exceed 10 mg/kg or 100 mg, whichever is less.
IMPORTANT SAFETY INFORMATION1
CONTRAINDICATIONS
CALDOLOR is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to ibuprofen or any components of the drug product, and in patients who have a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients. CALDOLOR is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
WARNINGS AND PRECAUTIONS1
CALDOLOR should be used with caution in patients with known cardiovascular (CV) disease or risk factors for CV disease, a history of peptic ulcer disease and/or GI bleeding, liver disease or symptoms of, hypertension, and heart failure. When used in such patients, attention to using the lowest effective dose for the shortest time period is important to reduce the risk of serious adverse events. Avoid use in pregnant women starting at 30 weeks gestation.
ADVERSE REACTIONS1
The most common adverse reactions are nausea, flatulence, vomiting, headache, hemorrhage and dizziness (>5%). The most common adverse reactions in pediatric patients are infusion site pain, vomiting, nausea, anemia and headache (≥2%).
CALDOLOR is a registered trademark of Cumberland Pharmaceuticals Inc.
© Cumberland Pharmaceuticals Inc. Nashville TN | WWW1470623 | June 2023