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Completed

NCT Number: NCT02244619

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

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Key information

Conditions

Post-op Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kettering Medical Center

Kettering, Ohio, 45429, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral acetaminophen

Drug

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

IV acetaminophen

Drug

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

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Kettering Health Network

Other

Registry information

Official study 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

Acronym: KHEA

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 19, 2014
Registry last updated
Jul 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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