CALDOLOR®

Caldolor Arthroscopic Knee Comparative Study to ketorolac13

Title of Study

Comparing the Efficacy of IV Ibuprofen and Ketorolac in the Management of Postoperative Pain Following Arthroscopic Knee Surgery. A Randomized Double-Blind Active Comparator Pilot Study.

Uribe A, Arbona F, Flanigan DC, et al.

Study Description

This was a single-center, randomized, double-blind, parallel, active comparator clinical pilot study. Subjects were randomized to receive either IV ibuprofen, administered as two 800 mg doses or IV ketorolac, administered as a single 30 mg dose. Subjects in the ibuprofen group received 800 mg of IV ibuprofen within 2 hours prior to surgery and a repeated second dose 4 hours after the initial dose if they had not been discharged. Subjects in the ketorolac group received IV ketorolac 30 mg at the end of surgery, as per the manufacturer’s recommendations. Pain assessments and opioid consumption data were collected up to 24 hours postoperatively.

  • Immediate PACU pain scores for the IV Ibuprofen group were statistically less than ketorolac (P=0.00064)
  • The IV Ibuprofen group VAS scores at rest demonstrated more than a two-fold reduction compared to ketorolac
  • Pain with movement was statistically less with the IV Ibuprofen group as compared to the ketorolac group
  • Mean narcotic consumption was significantly less in the IV Ibuprofen group as compared to ketorolac (P<0.001)

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