CALDOLOR®

Pediatric Pain Study3

Study Description

This was a multicenter, randomized, double-blind placebo-controlled trial conducted at six clinical sites in the United States. A total of 161 pediatric patients aged 6-16 years undergoing tonsillectomy were randomized to receive either a single preoperative dose of 10 mg/kg CALDOLOR or placebo (normal saline).

The primary objective of the study was to determine the efficacy of CALDOLOR compared to placebo when administered as a single dose at induction of anesthesia, on reducing the number of doses of postoperative fentanyl prior to discharge.

Study Results

  • Of the 161 patients enrolled, 138 were eligible for efficacy analysis.
  • There was a reduction in the number of postoperative doses (p=0.021) and the amount of fentanyl administered after surgery in the IV-Ibuprofen group compared to placebo (p=0.037).
  • Fewer patients in the IV ibuprofen group required more than one dose of rescue fentanyl.
  • There were no significant differences in surgical blood loss (p=0.662) or the incidence of postoperative bleeding (Safety Population, N=161).
  • Fewer patients in the IV-ibuprofen group experienced emesis in the 48 hours following discharge.
  • The most common adverse events reported in this study were vomiting, infusion site pain, agitation and nausea.

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