Acetaminophen Randomized Controlled Trial

Post Operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02737124
• Other study ID #: 15-01297
• Status: Withdrawn
• Phase: Phase 3
• Start date: February 16, 2017
• Est. completion date: March 19, 2018

Study information

• Verified date: July 2018
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 19, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• Acetaminophen
Acetaminophen will be given 24 hours before scheduled surgery.

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

Locations

Country	Name	City	State
United States	New York University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	7 days
Primary	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.	7 Days
Primary	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.	7 Days
Primary	Measure of time to discharge from the PACU	Time to discharge from the PACU	7 Days
Primary	Measure of time to discharge from hospital	Time to discharge from the hospital	7 Days