Does Preoperative Caldolor Decrease the Requirement for Postoperative Narcotics
1 other identifier
interventional
51
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 postoperative-pain
Started Feb 2011
Longer than P75 for phase_3 postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2010
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedFirst Posted
Study publicly available on registry
February 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedDecember 16, 2014
December 1, 2014
2.5 years
November 15, 2010
December 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Postoperative Visual Analog Pain Scale
7 days
Study Arms (2)
IV Caldolor
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
800 mg IV ibuprofen 30 minutes preoperatively
Eligibility Criteria
You may qualify if:
- primary inguinal and/or umbilical hernia repair
- age \> 18 years old
You may not qualify if:
- history of gastrointestinal bleeding
- allergy to ibuprofen
- creatinine \> 1.5 mg/dL
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- St. Barnabas Medical Centerlead
- Cumberland Pharmaceuticalscollaborator
Study Sites (1)
Saint Barnabas Medical Center
Livingston, New Jersey, 07039, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald S Chamberlain, MD, MPA, FACS
St. Barnabas Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chairman and Chief Department of Surgery
Study Record Dates
First Submitted
November 15, 2010
First Posted
February 17, 2011
Study Start
February 1, 2011
Primary Completion
August 1, 2013
Study Completion
March 1, 2015
Last Updated
December 16, 2014
Record last verified: 2014-12