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

Primary Purpose

Post-op Pain

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Oral acetaminophen
IV acetaminophen
Sponsored by
Kettering Health Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Post-op Pain focused on measuring Hip replacement, Knee replacement, randomized trial, acetaminophen, post-op pain management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kettering Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Oral acetaminophen

IV acetaminophen

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Total Post-operative Use of Opioids
Post-operative use of opioids, measured in morphine milligram equivalent (MME) units

Secondary Outcome Measures

Patient-rated Pain in the Post-operative Period
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.

Full Information

First Posted
September 16, 2014
Last Updated
July 21, 2017
Sponsor
Kettering Health Network
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1. Study Identification

Unique Protocol Identification Number
NCT02244619
Brief Title
PO vs. IV Acetaminophen Given Perioperatively for 24 hr Post-op Pain Control Following Total Hip or Knee Replacement
Acronym
KHEA
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kettering Health Network

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
Detailed Description
Subjects will be randomized to receive perioperative dosing of either: Oral acetaminophen (Tylenol) 1000mg with IV Placebo (100ml Normal Saline), OR, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-op Pain
Keywords
Hip replacement, Knee replacement, randomized trial, acetaminophen, post-op pain management

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
515 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral acetaminophen
Arm Type
Active Comparator
Arm Description
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.
Arm Title
IV acetaminophen
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Oral acetaminophen
Other Intervention Name(s)
Tylenol
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
IV acetaminophen
Other Intervention Name(s)
Ofirmev
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total Post-operative Use of Opioids
Description
Post-operative use of opioids, measured in morphine milligram equivalent (MME) units
Time Frame
During post-op period up to 24 hrs after surgery
Secondary Outcome Measure Information:
Title
Patient-rated Pain in the Post-operative Period
Description
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.
Time Frame
Standard-of-care post-op assessment intervals during post-op period up to 24 hrs after surgery
Other Pre-specified Outcome Measures:
Title
Post-operative Nausea and Vomiting
Time Frame
During post-op period up to 24 hrs after surgery
Title
Time to First Ambulation - 10 Feet
Time Frame
During post-op period up to 24 hours after surgery
Title
Time to First Rescue Opioid (PRN Order)
Time Frame
During post-op period up to 24 hrs after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sidney (Skip) Hickman, RPh
Organizational Affiliation
Kettering Health Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kettering Medical Center
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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