Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Intravenous ibuprofen
ibuprofen · 4 trials · 3 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)
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 |
| 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 |
| 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 ...