Does Preoperative Caldolor Decrease the Requirement for Postoperative Narcotics
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|ClinicalTrials.gov Identifier: NCT01297829|
Recruitment Status : Unknown
Verified December 2014 by Ronald S. Chamberlain, St. Barnabas Medical Center.
Recruitment status was: Active, not recruiting
First Posted : February 17, 2011
Last Update Posted : December 16, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain||Drug: Intravenous Ibuprofen Other: IV Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||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|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||August 2013|
|Estimated Study Completion Date :||March 2015|
|Active Comparator: IV Caldolor||
Drug: Intravenous Ibuprofen
800 mg IV ibuprofen 30 minutes preoperatively
Other Name: Caldolor
|Placebo Comparator: Placebo||
Other: IV Placebo
IV normal saline
- Postoperative Narcotic Use [ Time Frame: 7 days ]Post-operatively, the patient will receive a journal to record daily medication used up to and including post-operative day 7.
- Postoperative Visual Analog Pain Scale [ Time Frame: 7 days ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01297829
|United States, New Jersey|
|Saint Barnabas Medical Center|
|Livingston, New Jersey, United States, 07039|
|Principal Investigator:||Ronald S Chamberlain, MD, MPA, FACS||St. Barnabas Medical Center|