A Phase 3 interventional study of Intravenous Ibuprofen and IV Placebo in Postoperative Pain, sponsored by St. Barnabas Medical Center. Status unknown at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-12-16.
Sponsored by St. Barnabas Medical Center · Phase 3, Interventional, and Supportive care
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 51 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →St. Barnabas Medical Center is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Intravenous Ibuprofen
Other: IV Placebo
800 mg IV ibuprofen 30 minutes preoperatively
Also known as: Caldolor
IV normal saline
Postoperative Narcotic Use
Post-operatively, the patient will receive a journal to record daily medication used up to and including post-operative day 7.
Time frame: 7 days
Postoperative Visual Analog Pain Scale
The patient will receive a Visual Analog Pain Scale to complete 2 hrs post-operatively, post-operative day 1, post-operative day 3 and post-operative day 7
Time frame: 7 days
This study is status unknown, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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St. Barnabas Medical Center