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Acetaminophen Randomized Controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02737124
Recruitment Status : Withdrawn (Study is currently Lapsed)
First Posted : April 13, 2016
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
Patients that are to undergo isolated meniscectomy will be randomized to 2 cohorts: one will take the FDA recommended dose of acetominophen (1000mg) 24hrs before surgery, one will be given a similarly looking placebo pill. A multitude of post-op variables will be included, mainly pain scores and morphine equivalent doses at different time points.

Condition or disease Intervention/treatment Phase
Post Operative Pain Drug: Acetaminophen Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Prospective Randomized Control Trial Assessing Effects of Pre-Operative Acetaminophen in Isolated Meniscectomy Patients
Actual Study Start Date : February 16, 2017
Actual Primary Completion Date : March 1, 2018
Actual Study Completion Date : March 19, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1000 Mg Acetaminophen
Acetaminophen will be given 24 hours before surgery
Drug: Acetaminophen
Acetaminophen will be given 24 hours before scheduled surgery.

Active Comparator: Placebo
A sugar pill will be given 24 hours before the scheduled surgery.
Other: Placebo
Placebo will be given to subjects 24 hours before scheduled surgery.
Other Name: Sugar Pill




Primary Outcome Measures :
  1. Morphine-equivalent dose consumption [ Time Frame: 7 days ]
    Total morphine-equivalent dose consumption during immediate post-op, phase 1 recover, phase II recovery, at 2 days, and at 7 days

  2. Pain using the visual analogue scale [ Time Frame: 7 Days ]
    The visual analogue scale is a scale with a line from 0 on one side and 100 on the other where the patient is asked to mark where they believe their pain is.

  3. Narcotic Use [ Time Frame: 7 Days ]
    Total morphine-equivalent dose consumption during immediate post-op, phase 1 recover, phase II recovery, at 2 days, and at 7 days will also be recorded.

  4. Measure of time to discharge from the PACU [ Time Frame: 7 Days ]
    Time to discharge from the PACU

  5. Measure of time to discharge from hospital [ Time Frame: 7 Days ]
    Time to discharge from the hospital



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be at least 18 years of age
  • ASA Class I-II
  • Patients scheduled for meniscectomy

Exclusion Criteria:

  • Contraindication to acetaminophen (hypersensitivity, extensive alcohol history, liver disease, actively breastfeeding)
  • Legally incompetent or mentally impaired (e.g., minors, Alzheimer's subjects, dementia, etc.)
  • Younger than 18 years of age or older than 65
  • Any patient considered a vulnerable subject
  • Patients on pain medication prior to surgery

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): NCT02737124


Locations
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United States, New York
New York University Medical Center
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Eric Strauss, MD NYU Langone Health

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02737124     History of Changes
Other Study ID Numbers: 15-01297
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by NYU Langone Health:
Acetaminophen
Surgery
Meniscectomy
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics