Intravenous Acetaminophen for Non-Narcotic Postoperative Pain Management Following Knee Arthroscopy

NCT02025634 | Completed Phase 4 Results

• 1 other identifier: 503526
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this randomized, placebo controlled, single blind study is to determine if postoperative pain levels, as measured by a verbal numeric pain rating scale (VNRS), are reduced with the administration of IV acetaminophen when compared to a control group. Particular focus will be on the postoperative opioid consumption. In addition, we will ascertain if the total time the participant is in the PACU differs in those who receive the IV acetaminophen versus those who do not.

Conditions

Pain, Postoperative

Keywords

Pain, Postoperative; Ofirmev; Acetaminophen; Analgesics, Non-Narcotic; Arthroscopy

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Levels

  To determine if postoperative pain levels, as measured by a Verbal Numerical Rating Scale (VNRS), are reduced with the administration of IV acetaminophen when compared to a control group. In the VNRS, the user has the option to verbally rate their scale from 0 to 10. Zero indicates the absence of pain, while 10 represents the most intense pain possible.

  up to 8 hours

Secondary Outcomes (1)

• Postoperative Opioid Consumption

  up to 8 hours

Other Outcomes (1)

• Total Time in Post Anesthesia Care Unit (PACU) (or "Recovery Room")

  up to 8.6 hours

Study Arms (2)

Intravenous acetaminophen

EXPERIMENTAL

Infusion of Intravenous acetaminophen (Ofirmev)

Drug: Intravenous Acetaminophen

Placebo (0.9% Normal Saline Infusion)

PLACEBO COMPARATOR

Infusion of 100 ml of 0.9 NS Normal Saline

Drug: Placebo (0.9% Normal Saline infusion)

Interventions

Intravenous Acetaminophen DRUG

Participants randomized to intravenous acetaminophen (Ofirmev) will receive an infusion of Ofirmev in 100 ml of 0.9 NS according to manufacturer's recommendations related to subject's weight.

Also known as: Ofirmev

Intravenous acetaminophen

Placebo (0.9% Normal Saline infusion) DRUG

Infusion of 100 ml of 0.9% NS

Also known as: NS

Placebo (0.9% Normal Saline Infusion)

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is scheduled for knee arthroscopy with or without chondroplasty.
• Scheduled arthroscopy procedure will not include ligament repairs or ligament reconstructions and/or bone cutting or fixation procedures.
• Has not received any acetaminophen (IV, PR, PO) within at least 8 hours of the initiation of surgery.
• Is willing and able to sign an informed consent.

You may not qualify if:

• Is undergoing arthroscopy for ligament repairs/reconstructions and bone cutting or fixation procedures
• Has self-reported and/or documented previous hypersensitivity to acetaminophen.
• Has self-reported and/or documented history of hepatic disease or impairment.
• Pre-operative calculated creatinine clearance (CrCL) less than 40 ml/min.
• Has a medical history of alcohol abuse and/or currently drinks more than 3 alcoholic beverages per day.
• Has a medical history of substance dependence (i.e. prescription analgesics or illegal drugs such as cocaine, heroin, etc…). May be self-reported or maybe per the judgment of the physician PI/Sub-I.

Sponsors & Collaborators

• AdventHealth: lead
• University of Central Florida: collaborator

Study Sites (1)

Florida Hospital Celebration Health

Celebration, Florida, 34747, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Brad Homan
• Organization: AdventHealth

Brad.Homan.MD@AdventHealth.com

407-303-4270

Study Officials

• Bradley Homan, DO

  Florida Hospital Celebration Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2013
• First Posted: January 1, 2014
• Study Start: November 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 26, 2020
• Results First Posted: October 26, 2020

Record last verified: 2020-10

Locations

US (1)