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Does Preoperative Caldolor Decrease the Requirement for Postoperative Narcotics

NCT ID: NCT01297829

Last Updated: 2014-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2015-03-31

Brief Summary

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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

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Conditions

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Postoperative Pain

Keywords

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ibuprofen postoperative narcotics visual analog pain scale inguinal hernia repair umbilical hernia repair

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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IV Caldolor

Group Type ACTIVE_COMPARATOR

Intravenous Ibuprofen

Intervention Type DRUG

800 mg IV ibuprofen 30 minutes preoperatively

Placebo

Group Type PLACEBO_COMPARATOR

IV Placebo

Intervention Type OTHER

IV normal saline

Interventions

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Intravenous Ibuprofen

800 mg IV ibuprofen 30 minutes preoperatively

Intervention Type DRUG

IV Placebo

IV normal saline

Intervention Type OTHER

Other Intervention Names

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Caldolor

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cumberland Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

St. Barnabas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Ronald S. Chamberlain

Chairman and Chief Department of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ronald S Chamberlain, MD, MPA, FACS

Role: PRINCIPAL_INVESTIGATOR

St. Barnabas Medical Center

Locations

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Saint Barnabas Medical Center

Livingston, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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2010-11-15

Identifier Type: -

Identifier Source: org_study_id