Study Stopped
Study is currently Lapsed
Acetaminophen Randomized Controlled Trial
Prospective Randomized Control Trial Assessing Effects of Pre-Operative Acetaminophen in Isolated Meniscectomy Patients
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2017
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2016
CompletedFirst Posted
Study publicly available on registry
April 13, 2016
CompletedStudy Start
First participant enrolled
February 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 19, 2018
CompletedJuly 26, 2018
July 1, 2018
1 year
April 8, 2016
July 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Morphine-equivalent dose consumption
Total morphine-equivalent dose consumption during immediate post-op, phase 1 recover, phase II recovery, at 2 days, and at 7 days
7 days
Pain using the visual analogue scale
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.
7 Days
Narcotic Use
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.
7 Days
Measure of time to discharge from the PACU
Time to discharge from the PACU
7 Days
Measure of time to discharge from hospital
Time to discharge from the hospital
7 Days
Study Arms (2)
1000 Mg Acetaminophen
EXPERIMENTALAcetaminophen will be given 24 hours before surgery
Placebo
ACTIVE COMPARATORA sugar pill will be given 24 hours before the scheduled surgery.
Interventions
Acetaminophen will be given 24 hours before scheduled surgery.
Placebo will be given to subjects 24 hours before scheduled surgery.
Eligibility Criteria
You may qualify if:
- Must be at least 18 years of age
- ASA Class I-II
- Patients scheduled for meniscectomy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York University Medical Center
New York, New York, 10016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Strauss, MD
NYU Langone Health
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2016
First Posted
April 13, 2016
Study Start
February 16, 2017
Primary Completion
March 1, 2018
Study Completion
March 19, 2018
Last Updated
July 26, 2018
Record last verified: 2018-07