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

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ClinicalTrials.gov Identifier: NCT02244619
Recruitment Status : Completed
First Posted : September 19, 2014
Results First Posted : July 24, 2017
Last Update Posted : July 24, 2017
Sponsor:
Information provided by (Responsible Party):
Kettering Health Network

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

Condition or disease Intervention/treatment Phase
Post-op Pain Drug: Oral acetaminophen Drug: IV acetaminophen Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 515 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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
Actual Study Start Date : September 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


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.
Drug: Oral acetaminophen
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 Name: 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.
Drug: IV acetaminophen
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 Name: Ofirmev




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Post-operative Nausea and Vomiting [ Time Frame: During post-op period up to 24 hrs after surgery ]
  2. Time to First Ambulation - 10 Feet [ Time Frame: During post-op period up to 24 hours after surgery ]
  3. Time to First Rescue Opioid (PRN Order) [ Time Frame: During post-op period up to 24 hrs after surgery ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02244619


Locations
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United States, Ohio
Kettering Medical Center
Kettering, Ohio, United States, 45429
Sponsors and Collaborators
Kettering Health Network
Investigators
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Principal Investigator: Sidney (Skip) Hickman, RPh Kettering Health Network

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Responsible Party: Kettering Health Network
ClinicalTrials.gov Identifier: NCT02244619     History of Changes
Other Study ID Numbers: KMCPH-13-001
First Posted: September 19, 2014    Key Record Dates
Results First Posted: July 24, 2017
Last Update Posted: July 24, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Kettering Health Network:
Hip replacement
Knee replacement
randomized trial
acetaminophen
post-op pain management
Additional relevant MeSH terms:
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Acetaminophen
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics