CALDOLOR®

Hysterectomy Pain Study5

Study Description

A multi-center, randomized, double-blind, placebo-controlled trial evaluating the safety and analgesic efficacy of IV Ibuprofen vs. placebo in 319 patients undergoing elective abdominal hysterectomy.

Study Results

A total of 319 female patients were randomized into two treatment groups that both had open access to morphine, with 153 patients in the placebo group and 166 patients in the IV Ibuprofen group. The first dose of 800 mg of IV Ibuprofen was administered at surgical closure, and every 6 hours for up to 5 days, in addition to open access morphine. The primary efficacy endpoint was a reduction in the requirement for morphine during the first 24 hours following surgery as measured by total morphine usage compared with placebo. Additional endpoints included reduction in pain intensity as measured by VAS over the immediate 24 hours following surgery, and incidence of opioid related side effects. This study demonstrated that IV Ibuprofen is an effective analgesic medication that is safe and well tolerated when administered as an 800 mg dose every 6 hours in patients undergoing total abdominal hysterectomy surgery.  

Morphine Use

  • There was a 20% reduction in morphine use with 800 mg IV Ibuprofen in the immediate 24 hour period following surgery  (p< 0.001).

VAS assessed at rest and with movement with 800 mg IV Ibuprofen over the immediate 24 hours following surgery:

  • This study demonstrated a 21% reduction in VAS scores at rest with 800 mg IV Ibuprofen over the immediate 24 hours following surgery  (p= 0.003).
  • This study demonstrated a 15% reduction in VAS scores with movement in the 800 mg IV Ibuprofen group over the immediate 24 hours following surgery  (p= 0.0001).
  • The most common adverse events reported in this study were nausea, flatulence, pruritus, constipation, vomiting and headache.

 

CALDOLOR must be diluted prior to use. Infusion of the drug product without dilution can cause hemolysis. CALDOLOR should not be given as an IV bolus or IM injection.1

INDICATIONS AND USAGE1
CALDOLOR is indicated in adults and pediatric patients 6 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 must be diluted prior to administration.
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.

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%).

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.
Gastrointestinal Bleeding, Ulceration and Performation
  • 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.

PLEASE SEE FULL PRESCRIBING INFORMATION INCLUDING BOXED WARNING