Does Preoperative Caldolor Decrease the Requirement for Postoperative Narcotics

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01297829
• Other study ID #: 2010-11-15
• Status: Active, not recruiting
• Phase: Phase 3
• First received: November 15, 2010
• Last updated: December 12, 2014
• Start date: February 2011
• Est. completion date: March 2015

Study information

• Verified date: December 2014
• Source: St. Barnabas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 51
• Est. completion date: March 2015
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• primary inguinal and/or umbilical hernia repair

• age > 18 years old

Exclusion Criteria:

• history of gastrointestinal bleeding

• allergy to ibuprofen

• creatinine > 1.5 mg/dL

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Intravenous Ibuprofen
800 mg IV ibuprofen 30 minutes preoperatively

Other:
• IV Placebo
IV normal saline

Locations

Country	Name	City	State
United States	Saint Barnabas Medical Center	Livingston	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
St. Barnabas Medical Center	Cumberland Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Narcotic Use	Post-operatively, the patient will receive a journal to record daily medication used up to and including post-operative day 7.	7 days	No
Secondary	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	7 days	No