Acetaminophen Randomized Controlled Trial

Phase 3

Withdrawn

• Conditions: Post Operative Pain
• Interventions: Other: Placebo; Drug: Acetaminophen

• Registration Number: NCT02737124
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-04-08
• Study First Submitted QC: 2016-04-12
• Study First Posted: 2016-04-13
• Study Start: 2017-02-16
• Primary Completion: 2018-03-01
• Study Completion: 2018-03-19
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-23
• Last Update Posted: 2018-07-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	A sugar pill will be given 24 hours before the scheduled surgery.
1000 Mg Acetaminophen	Acetaminophen	Acetaminophen will be given 24 hours before surgery

Primary Outcome Measures

Name	Time	Method
Pain using the visual analogue scale	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.
Narcotic Use	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.
Measure of time to discharge from the PACU	7 Days	Time to discharge from the PACU
Morphine-equivalent dose consumption	7 days	Total morphine-equivalent dose consumption during immediate post-op, phase 1 recover, phase II recovery, at 2 days, and at 7 days
Measure of time to discharge from hospital	7 Days	Time to discharge from the hospital

Trial Locations

Locations (1)

New York University Medical Center; 🇺🇸 New York, New York, United States