Acetaminophen Randomized Controlled Trial

NCT ID: NCT02737124

Last Updated: 2018-07-26

Study Results

Results pending

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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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-16

Study Completion Date

2018-03-19

Brief Summary

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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.

Detailed Description

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Conditions

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Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1000 Mg Acetaminophen

Acetaminophen will be given 24 hours before surgery

Group Type EXPERIMENTAL

Acetaminophen

Intervention Type DRUG

Acetaminophen will be given 24 hours before scheduled surgery.

Placebo

A sugar pill will be given 24 hours before the scheduled surgery.

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type OTHER

Placebo will be given to subjects 24 hours before scheduled surgery.

Interventions

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Acetaminophen

Acetaminophen will be given 24 hours before scheduled surgery.

Intervention Type DRUG

Placebo

Placebo will be given to subjects 24 hours before scheduled surgery.

Intervention Type OTHER

Other Intervention Names

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Sugar Pill

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric Strauss, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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New York University Medical Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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15-01297

Identifier Type: -

Identifier Source: org_study_id

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