CALDOLOR®

Third Molar Surgical Study Comparing Caldolor® to Ofirmev®12

Title of Study

Does Pre-Emptive Administration of Intravenous Ibuprofen (Caldolor) or Intravenous Acetaminophen (Ofirmev) Reduce Postoperative Pain and Subsequent Narcotic Consumption After Third Molar Surgery?

Viswanath A, Oreadi D, Finkelman M, et al.

Study Description

In this randomized, single-blinded clinical study, 41 patients undergoing surgical extraction of 2 or more impacted third molars under deep sedation were administered either 800 mg of IV ibuprofen or 1,000 mg of IV acetaminophen 30 minutes before molar extraction. Postoperative pain as assessed by visual analog scale (VAS) at different time points and amount of postoperative analgesic (narcotic and over-the-counter [OTC]) medication were compared between the subjects receiving IV ibuprofen and IV acetaminophen.

Study Results

  • Patients who received IV ibuprofen reported significantly lower VAS scores measured at 4 (p= 0.004), 24 (p= 0.019), and 48 hours (p= 0.017) than patients who received IV-acetaminophen.
  • IV ibuprofen subjects also took significantly fewer (p= 0.005) narcotic medications than the IV acetaminophen subjects.
  • The maximum number of OTC medication doses taken by IV ibuprofen subjects was 22 versus a maximum of 51 doses in IV acetaminophen subjects. Moreover, the median number of OTC doses taken by IV ibuprofen subjects was 2 versus a median of 6 doses taken by IV acetaminophen subjects.

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

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 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.

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 Perforation
  • 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