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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
Cumberland Pharmaceuticals
Information provided by (Responsible Party):
Ronald S. Chamberlain, 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.

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
Allocation: Randomized
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
Primary Completion Date : August 2013
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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
Sponsors and Collaborators
St. Barnabas Medical Center
Cumberland Pharmaceuticals
Principal Investigator: Ronald S Chamberlain, MD, MPA, FACS St. Barnabas Medical Center

Responsible Party: Ronald S. Chamberlain, Chairman and Chief Department of Surgery, St. Barnabas Medical Center
ClinicalTrials.gov Identifier: NCT01297829     History of Changes
Other Study ID Numbers: 2010-11-15
First Posted: February 17, 2011    Key Record Dates
Last Update Posted: December 16, 2014
Last Verified: December 2014

Keywords provided by Ronald S. Chamberlain, St. Barnabas Medical Center:
postoperative narcotics
visual analog pain scale
inguinal hernia repair
umbilical hernia repair

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Depressants