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Label indication CALDOLOR is indicated in adults and pediatric patients aged 3 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 CALDOLOR is a nonsteroidal anti-inflammatory drug indicated in adults and pediatric patients aged 3 months and older for the: Management of mild to moderate pain and the management of moderate to… FDA label
Also known as Ibuprofen, Intravenous ibuprofen, IV ibuprofen
Caldolor · 7 trials · 4 indications
To evaluate the primary objective of reduced fentanyl use in the post-operative period, the number of fentanyl doses (0.5 mcg/kg IV) administered in the post-operative period prior to discharge will be measured.
Treatment of fever as measured by the area under the change in temperature versus time curve during the first two hours of treatment (AUC0-2)
Area under the curve temperature from baseline to hour 24 following initiation of treatment.
Measurement of the patient's self assessment of pain with movement using the validated visual analog scale (VAS) during the post-operative period (study hour-6 through hour-28). VAS assessments document the patient's self reported level of pain from "No pain" (0 mm) to "Worst possible pain" (100 mm) on a 100 mm line. VAS assessments were performed immediately following surgery \[variable since every surgery has a unique length of time even if it is the same procedure\] and at hours 6, 8, 12, 16, 20, 24 and 28 (for the primary endpoint).
Change in the amount of morphine use (in milligrams) by subjects in each treatment group for a 24 hour period post-surgery
| Arm | Type | Description |
|---|---|---|
| Intravenous Ibuprofen | EXPERIMENTAL | - |
| Normal Saline | PLACEBO_COMPARATOR | - |
| ibuprofen | EXPERIMENTAL | Ibuprofen, 10 mg/kg |
| Acetaminophen | ACTIVE_COMPARATOR | Acetaminophen, 10mg/kg |
| 1 | PLACEBO_COMPARATOR | - |
| 2 | EXPERIMENTAL | - |
| Saline | PLACEBO_COMPARATOR | Normal Saline |
| Name | Type | Description |
|---|---|---|
| Intravenous ibuprofen | DRUG | Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia. |
| Normal Saline | OTHER | Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia. |
| ibuprofen | DRUG | Ibuprofen, 10 mg/kg |
| acetaminophen | DRUG | Acetaminophen, 10mg/kg |
| Caldolor | DRUG | 800 milligrams of intravenous ibuprofen (patients greater 12 years of age) or 10 milligrams/kilograms (patients greater than 12 years; maximum of 400 milligrams) every 6 hours |
| Placebo | DRUG | Placebo |
| Normal saline as placebo comparator | OTHER | 250 ml normal saline as a placebo comparator was administered every 6 hours for a total of eight doses over the first 48 hours. Those patients who received the initial eight doses could continue to receive additional doses as needed through the end of the treatment period (day 5) |
Inclusion Criteria: 1\. Patients between 6 and 17 years of age scheduled to undergo tonsillectomy. Exclusion Criteria: 1. Have inadequate intravenous access 2. Patients with significant cognitive impairment 3. Active, clinically significant asthma 4. History of allergy or hypersensitivity to any ...
Caldolor is an intravenous formulation of ibuprofen used to treat fever, pain, and burns in hospitalized patients. It is being studied in pediatric and adult populations for these conditions, including febrile pediatric patients, adult orthopedic patients with pain, and burn patients.
Caldolor targets the enzyme cyclooxygenase (COX), which is involved in the production of prostaglandins that mediate fever and pain. By inhibiting COX, Caldolor reduces fever and provides analgesic effects in hospitalized patients.
Caldolor is developed by Cumberland Pharmaceuticals Inc., a biopharmaceutical company listed on the Nasdaq under the ticker symbol CPIX. The company is conducting clinical trials to evaluate the drug's efficacy and safety in various patient populations.
Caldolor is in Phase 3 clinical development. It has completed three Phase 3 trials, including studies in febrile pediatric patients, adult orthopedic patients with pain, and burn patients. The drug is investigational and not yet approved by regulatory authorities.
Caldolor has completed three Phase 3 trials: NCT00225706 in hospitalized febrile pediatric patients, NCT00470600 in hospitalized adult orthopedic patients with pain, and NCT00606489 in hospitalized adult and pediatric burn patients. All trials are completed and were conducted in multiple countries.
Caldolor is an intravenous formulation of ibuprofen, a nonsteroidal anti-inflammatory drug. It is designed for hospital use to manage fever and pain when oral administration is not feasible. The drug is being developed by Cumberland Pharmaceuticals.