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
|Condition or disease||Intervention/treatment||Phase|
|Post-op Pain||Drug: Oral acetaminophen Drug: IV acetaminophen||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||515 participants|
|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|
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
- 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
- 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.
- Post-operative Nausea and Vomiting [ Time Frame: 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 ]
- Time to First Rescue Opioid (PRN Order) [ Time Frame: During post-op period up to 24 hrs after surgery ]
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
|United States, Ohio|
|Kettering Medical Center|
|Kettering, Ohio, United States, 45429|
|Principal Investigator:||Sidney (Skip) Hickman, RPh||Kettering Health Network|