Status:
COMPLETED
PO vs. IV Acetaminophen Given Perioperatively for 24 hr Post-op Pain Control Following Total Hip or Knee Replacement
Lead Sponsor:
Kettering Health Network
Conditions:
Post-op Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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
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 wit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
515 Patients enrolled
Trial Details
Trial ID
NCT02244619
Start Date
September 1 2014
End Date
April 1 2016
Last Update
July 24 2017
Active Locations (1)
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1
Kettering Medical Center
Kettering, Ohio, United States, 45429