A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Relationship Between Intraoperative Intravenous Acetaminophen and Postoperative Opioid Avoidance for Ambulatory Surgical Procedures
NCT ID: NCT01231191
Last Updated: 2012-03-08
Study Results
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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WITHDRAWN
PHASE4
INTERVENTIONAL
Brief Summary
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Detailed Description
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Hypothesis: Adding an intraoperative dose of intravenous acetaminophen to usual and customary analgesics during ambulatory surgery increases the proportion of patients remaining opioid-free in the post-anesthesia recovery room.
Secondary Specific Aim: To determine if adding an intraoperative dose of intravenous acetaminophen to usual and customary analgesics during amublatory surgery impacts the required doses of additional perioperative analgesics.
Hypothesis: Adding an intraoperative dose of intravenous acetaminophen to usual and customary analgesics during ambulatory surgery decreases the required doses of additional analgesics in both the operating room and post-anesthesia recovery room.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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IV Acetaminophen
Intraoperative IV acetaminophen administered
Intravenous acetaminophen
Acetaminophen 1000 mg administered over 15 minutes intravenously as soon as feasible intraoperatively.
IV Placebo
Intraoperative IV normal saline administered
Intravenous placebo
Normal saline administered over 15 minutes intravenously as soon as feasible intraoperatively.
Interventions
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Intravenous acetaminophen
Acetaminophen 1000 mg administered over 15 minutes intravenously as soon as feasible intraoperatively.
Intravenous placebo
Normal saline administered over 15 minutes intravenously as soon as feasible intraoperatively.
Eligibility Criteria
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Inclusion Criteria
* Expected postoperative pain to be mild-moderate
* Age 18 years or older
* Have an ASA physical status or 1, 2, or 3
Exclusion Criteria
* Any physical, mental or medical conditions which may confound quantifying postoperative pain resulting from surgery
* Current chronic opioid or tramadol use
* History of alcohol or opioid abuse
* Known allergy to the study medications
* Pregnancy
* Any health condition requiring greater than 100 micrograms of fentanyl during anesthesia induction
* Treated with any acetaminophen-containing medication in the previous 8 hours
* Treated with MAO inhibitors within 10 days prior to surgery
* Inability to communicate with the investigators and hospital staff
* Known or impaired liver function
18 Years
ALL
No
Sponsors
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Cadence Pharmaceuticals
INDUSTRY
University of California, San Diego
OTHER
Responsible Party
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Brian M. Ilfeld, MD, MS
Associate Professor, In Residence
Principal Investigators
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Brian M Ilfeld, M.D., M.S.
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
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UCSD Medical Center (Hillcrest and Thornton)
San Diego, California, United States
Countries
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Other Identifiers
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IV Acetaminophen
Identifier Type: -
Identifier Source: org_study_id
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