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

Kettering Health Network515 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

515

Conditions

Post-op Pain

Interventions

Oral acetaminophenDRUG

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.

IV acetaminophenDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Kettering Medical Center

Kettering, Ohio, United States

Outcomes

Primary Outcomes

Total Post-operative Use of Opioids

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 Outcomes

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.

Time frame: Standard-of-care post-op assessment intervals during post-op period up to 24 hrs after surgery

Data from ClinicalTrials.gov

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