Does Preoperative Caldolor Decrease the Requirement for Postoperative Narcotics

Phase 3

• Conditions: Postoperative Pain
• Interventions: Drug: Intravenous Ibuprofen; Other: IV Placebo

• Registration Number: NCT01297829
• Lead Sponsor: St. Barnabas Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-15
• Study Start: 2011-02
• Study First Submitted QC: 2011-02-16
• Study First Posted: 2011-02-17
• Primary Completion: 2013-08
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-12
• Last Update Posted: 2014-12-16
• Study Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 51

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV Caldolor	Intravenous Ibuprofen	-
Placebo	IV Placebo	-

Primary Outcome Measures

Name	Time	Method
Postoperative Narcotic Use	7 days	Post-operatively, the patient will receive a journal to record daily medication used up to and including post-operative day 7.

Secondary Outcome Measures

Name	Time	Method
Postoperative Visual Analog Pain Scale	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

Trial Locations

Locations (1)

Saint Barnabas Medical Center; 🇺🇸 Livingston, New Jersey, United States