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 |
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.
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
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Cooper University Hospital Cooper University Health Care, the clinical campus of Cooper Medical School of...
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New York Methodist Hospital A voluntary, acute-care teaching hospital, New York Methodist Hospital's mission is...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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