NCT01297829

Does Preoperative Caldolor Decrease the Requirement for Postoperative Narcotics

Does Preoperative Caldolor Decrease the Requirement for Postoperative Narcotics in Patients Undergoing Laparoscopic or Open Inguinal and/or Umbilical Hernia Repair? A Randomized, Double-Blind, Prospective Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: St. Barnabas Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Intravenous Ibuprofen	800 mg IV ibuprofen 30 minutes preoperatively
OTHER	IV Placebo	IV normal saline

Timeline

• Start date: 2011-02-01
• Primary completion: 2013-08-01
• Completion: 2015-03-01
• First posted: 2011-02-17
• Last updated: 2014-12-16

Locations

1 site across 1 country: United States