Acetaminophen Randomized Controlled Trial

Prospective Randomized Control Trial Assessing Effects of Pre-Operative Acetaminophen in Isolated Meniscectomy Patients

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02737124

Enrollment

Registered

2016-04-13

Start date

2017-02-16

Completion date

2018-03-19

Last updated

2018-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative Pain

Keywords

Acetaminophen, Surgery, Meniscectomy

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.

Interventions

OTHERPlacebo

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

DRUGAcetaminophen

Acetaminophen will be given 24 hours before scheduled surgery.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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
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
Measure of time to discharge from hospital	7 Days	Time to discharge from the hospital

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026