A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™) for the Treatment of Post-Operative Pain in Patients After Open Abdominal Surgery



Status:Completed
Conditions:Post-Surgical Pain, Hospital
Therapuetic Areas:Musculoskeletal, Other
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:February 2012
End Date:February 2013

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The purpose of this study is to compare the efficacy and safety of the Sufentanil NanoTab
PCA System/15 mcg to the Placebo Sufentanil NanoTab PCA System for the management of acute
moderate to severe post-operative pain after open abdominal surgery.


Inclusion Criteria:

- Male or female patients who are 18 years or older

- Patients who are scheduled to undergo an open abdominal surgery (including
laparoscopic-assisted) under general anesthesia or spinal anesthesia that does not
include intrathecal opioids during the operation.

- Post-surgical patients who have been admitted to the PACU and are expected to remain
hospitalized and to have acute post-operative pain requiring parenteral opioids for
at least 48 hours after surgery.

Exclusion Criteria:

- Patients who have taken an opioid for more than 30 consecutive days, at a daily dose
of more than 15 mg of morphine (or equivalent), within the past 3 months prior to
surgery (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg
hydrocodone per tablet).

- Patients with an allergy or hypersensitivity to opioids.

- Female patients who are pregnant or breast-feeding
We found this trial at
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Chicago, Illinois 60612
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506 6th St
Brooklyn, New York 11215
(718) 780-3000
New York Methodist Hospital A voluntary, acute-care teaching hospital, New York Methodist Hospital's mission is...
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1 Cooper Plaza
Camden, New Jersey 08103
(856) 342-2000
Cooper University Hospital Cooper University Health Care, the clinical campus of Cooper Medical School of...
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Camden, NJ
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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Houston, TX
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Jackson, Mississippi 39202
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Laguna Hills, California 92653
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Mobile, Alabama 36607
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Moorestown, New Jersey 08057
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Philadelphia, Pennsylvania 19107
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Stamford, Connecticut 06904
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Vero Beach, Florida 32960
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Vero Beach, FL
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