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Label indication Uses temporarily: • reduces fever • relieves minor aches and pains due to the common cold, flu, headaches and toothaches
Also known as Intravenous ibuprofen, Caldolor
ibuprofen · 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 ...
Intravenous ibuprofen is used to treat fever and pain. It is studied in hospitalized patients, including adults with fever and post-operative pain, and pediatric patients undergoing tonsillectomy. It is an injectable form of ibuprofen developed by Cumberland Pharmaceuticals Inc. under the ticker CPIX.
Intravenous ibuprofen is a small molecule inhibitor of the enzymes PTGS2 and PTGS1, also known as cyclooxygenase-2 and cyclooxygenase-1. By inhibiting these targets, it reduces the production of prostaglandins that cause fever and pain. This mechanism is the same as oral ibuprofen but delivered directly into the bloodstream.
Intravenous ibuprofen is developed by Cumberland Pharmaceuticals Inc., which trades under the ticker CPIX. The company is responsible for its clinical development and regulatory submissions.
Intravenous ibuprofen is in Phase 3 clinical development. It has completed Phase 3 trials but is not yet approved by the FDA for the studied indications. Cumberland Pharmaceuticals Inc. is the sponsor.
Intravenous ibuprofen has been studied in completed Phase 3 trials including NCT01332253 in pediatric tonsillectomy pain, NCT01131000 in adult febrile patients, NCT01002573 in pediatric fever, and NCT00225732 in post-operative adult pain. These trials enrolled a total of 319 patients in the post-operative pain study and smaller numbers in the others.
Intravenous ibuprofen is a formulation of ibuprofen, the same active ingredient found in oral ibuprofen. It is also known as intravenous ibuprofen. The difference is the route of administration: it is given intravenously rather than by mouth, allowing for rapid delivery in hospital settings.