PO vs. IV Acetaminophen Given Perioperatively for 24 hr Post-op Pain Control Following Total Hip or Knee Replacement (KHEA)

July 21, 2017 updated by: Kettering Health Network

Randomized, Double-Blind, Study Comparing Oral Acetaminophen Plus Intravenous (IV) Placebo to Oral Placebo Plus IV Acetaminophen Given Perioperatively for Controlling Pain in the 24hr Post-op Period After Total Hip or Knee Joint Replacement

The purpose of the study is to evaluate post-op pain requirements in patients undergoing hip or knee replacement surgery who perioperatively receive either Oral acetaminophen or IV acetaminophen

Study Overview

Status

Completed

Conditions

Detailed Description

Subjects will be randomized to receive perioperative dosing of either:

  1. Oral acetaminophen (Tylenol) 1000mg with IV Placebo (100ml Normal Saline), OR,
  2. IV acetaminophen (Ofirmev) 1000mg/100ml with Oral Placebo (oral capsules).

Subject pain levels and post-operative opioid use will be tracked for up to 24 hours after surgery.

Study Type

Interventional

Enrollment (Actual)

515

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ohio
      • Kettering, Ohio, United States, 45429
        • Kettering Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age and older
  • Able to provide written consent
  • Able to read and write in English
  • Weighing over 50 kg
  • Will undergo total hip or total knee joint replacement

Exclusion Criteria:

  • Non-verbal patients
  • Unable to use numeric pain scale
  • Allergic to the test article
  • Documented hepatic impairment or failure
  • Current illicit drug use
  • Requires traumatic or emergent surgery
  • Pregnant women
  • Women who are breastfeeding
  • Prisoners
  • Cognitively impaired requiring Legally Authorized Representative (LAR) or Power of Attorney (POA)
  • Unable to swallow oral capsules

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Oral acetaminophen
Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.
Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.
Other Names:
  • Tylenol
Active Comparator: IV acetaminophen
Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.
Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.
Other Names:
  • Ofirmev

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Post-operative Use of Opioids
Time Frame: During post-op period up to 24 hrs after surgery
Post-operative use of opioids, measured in morphine milligram equivalent (MME) units
During post-op period up to 24 hrs after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-rated Pain in the Post-operative Period
Time Frame: Standard-of-care post-op assessment intervals during post-op period up to 24 hrs after surgery
Patient-rated pain in the post-operative period was collected using a 10-point visual analog scale (VAS). A score of 0 indicates no pain; higher scores indicate greater pain. Minimum score for each VAS measurement is 0; Maximum score for each VAS measurement is 10. VAS scores were averaged for each patient.
Standard-of-care post-op assessment intervals during post-op period up to 24 hrs after surgery

Other Outcome Measures

Outcome Measure
Time Frame
Post-operative Nausea and Vomiting
Time Frame: During post-op period up to 24 hrs after surgery
During post-op period up to 24 hrs after surgery
Time to First Ambulation - 10 Feet
Time Frame: During post-op period up to 24 hours after surgery
During post-op period up to 24 hours after surgery
Time to First Rescue Opioid (PRN Order)
Time Frame: During post-op period up to 24 hrs after surgery
During post-op period up to 24 hrs after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sidney (Skip) Hickman, RPh, Kettering Health Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

September 16, 2014

First Submitted That Met QC Criteria

September 18, 2014

First Posted (Estimate)

September 19, 2014

Study Record Updates

Last Update Posted (Actual)

July 24, 2017

Last Update Submitted That Met QC Criteria

July 21, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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