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



Status:Completed
Conditions:Post-Surgical Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - Any
Updated:3/11/2017
Start Date:September 2014
End Date:April 2016

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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

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.

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
We found this trial at
1
site
3535 Southern Blvd
Kettering, Ohio 45429
(937) 298-4331
Principal Investigator: Skip Hickman, RPh
Phone: 937-395-8390
Kettering Medical Center Our flagship hospital, Kettering Medical Center, stands proudly in Kettering, Ohio. From...
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Kettering, OH
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