Back to resultsAcetaminophen Randomized Controlled Trial
Primary Purpose
Post Operative Pain
Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Acetaminophen
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Pain focused on measuring Acetaminophen, Surgery, Meniscectomy
Eligibility 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
Sites / Locations
- New York University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1000 Mg Acetaminophen
Placebo
Arm Description
Acetaminophen will be given 24 hours before surgery
A sugar pill will be given 24 hours before the scheduled surgery.
Outcomes
Primary Outcome Measures
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
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.
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.
Measure of time to discharge from the PACU
Time to discharge from the PACU
Measure of time to discharge from hospital
Time to discharge from the hospital
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02737124
Brief Title
Acetaminophen Randomized Controlled Trial
Official Title
Prospective Randomized Control Trial Assessing Effects of Pre-Operative Acetaminophen in Isolated Meniscectomy Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Study is currently Lapsed
Study Start Date
February 16, 2017 (Actual)
Primary Completion Date
March 1, 2018 (Actual)
Study Completion Date
March 19, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
Acetaminophen, Surgery, Meniscectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1000 Mg Acetaminophen
Arm Type
Experimental
Arm Description
Acetaminophen will be given 24 hours before surgery
Arm Title
Placebo
Arm Type
Active Comparator
Arm Description
A sugar pill will be given 24 hours before the scheduled surgery.
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Intervention Description
Acetaminophen will be given 24 hours before scheduled surgery.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar Pill
Intervention Description
Placebo will be given to subjects 24 hours before scheduled surgery.
Primary Outcome Measure Information:
Title
Morphine-equivalent dose consumption
Description
Total morphine-equivalent dose consumption during immediate post-op, phase 1 recover, phase II recovery, at 2 days, and at 7 days
Time Frame
7 days
Title
Pain using the visual analogue scale
Description
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.
Time Frame
7 Days
Title
Narcotic Use
Description
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.
Time Frame
7 Days
Title
Measure of time to discharge from the PACU
Description
Time to discharge from the PACU
Time Frame
7 Days
Title
Measure of time to discharge from hospital
Description
Time to discharge from the hospital
Time Frame
7 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Strauss, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Acetaminophen Randomized Controlled Trial
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