Acetaminophen Randomized Controlled Trial

NYU Langone Health

Status and phase: Withdrawn; Phase 3

Conditions: Post Operative Pain

Treatments: Drug: Acetaminophen; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02737124

15-01297

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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0 participants in 2 patient groups

1000 Mg Acetaminophen

Experimental group

Description:

Acetaminophen will be given 24 hours before surgery

Treatment:

Drug: Acetaminophen

Placebo

Active Comparator group

Description:

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

Treatment:

Other: Placebo