Does Preoperative Caldolor Decrease the Requirement for Postoperative Narcotics
Status unconfirmed · Phase 3 · Has a placebo group
Conditions studied: Postoperative Pain
In brief
Caldolor® is an intravenous (IV) formulation of ibuprofen encompassing analgesic, anti-inflammatory and antipyretic (anti-fever) properties. Caldolor® is the first IV antipyretic approved by the US Food and Drug Administration (FDA), providing an alternate route for administration of ibuprofen when the oral route is not preferable. Recent studies have reported that Caldolor® decreases morphine use and pain at rest and with movement compared to patients not receiving this drug. The hypothesis of the proposed study is that a single dose of Caldolor® 800 mg given 30 minutes preoperatively for patients undergoing laparoscopic or open inguinal and/or umbilical hernia repair will result in a \>20% decrease in postoperative narcotic use within the first 24 hours and at 7 days, and decreased VAS Pain Score at 2 hours, 1 day, 3 days and 7 days after surgery. The use of less postoperative narcotics has been associated with a faster return of normal bowel function and resumption of normal ambulatory status thus resulting in improved general well being for the patient.
Key facts
- Study ID
- NCT01297829
- Run by
- St. Barnabas Medical Center
- People needed
- 51
- Starts
- 2011-02-01
- Expected to finish
- 2015-03-01
- Last updated by the study team
- 2014-12-16
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- primary inguinal and/or umbilical hernia repair
- age > 18 years old
You may not qualify if…
- history of gastrointestinal bleeding
- allergy to ibuprofen
- creatinine > 1.5 mg/dL
Where it is running
- Saint Barnabas Medical Center — Livingston, New Jersey, United States
Full record on ClinicalTrials.gov
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