Status:
WITHDRAWN
Intravenous Acetaminophen as Adjuvant Therapy for Pain Control in Geriatric Hip Fracture Patients
Lead Sponsor:
Lancaster General Hospital
Conditions:
Pain
Hip Fracture
Eligibility:
All Genders
65+ years
Phase:
PHASE3
Brief Summary
This research study is a prospective, randomized, blinded, placebo controlled trial evaluating the benefit of IV acetaminophen (Ofirmev™) as adjuvant analgesia in geriatric hip fracture patients. IV a...
Detailed Description
Approximately 46 subjects will be enrolled at LGH. Subjects will be randomized 1:1 to receive either IV acetaminophen 1000 mg q6 hours (FDA recommended dose) or IV placebo. While receiving the study d...
Eligibility Criteria
Inclusion
- All patients aged at least 65 years with a diagnosis of hip fracture with whom surgical intervention is expected
- Patients with the following surgeons ( David Hughes MD, Gerald Rothacker MD, Frank Essis MD, James Carson MD, Michael Gish MD, Vincent Battista MD)
Exclusion
- Documented drug or alcohol addiction or abuse
- Documented serum sodium levels \> 145 mmol/L
- Documented serum chloride levels \> 107 mmol/L
- Impaired liver function defined as an ALT or AST \> 3 times the upper limit of normal, Child-Pugh class C, or patients with documented active liver disease
- Known allergy or intolerance to acetaminophen
- Weight ≤ 50 kg
- Creatinine clearance (CrCl) ≤ 30 ml/min as determined by the Cockcroft-Gault equation
- Documented dementia
- Acetaminophen (\> 650 mg) or opioid (\> 7 mg IV morphine equivalence) use within the previous 24 hours
- Documented chronic opioid use
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01520298
Start Date
December 1 2011
End Date
May 1 2013
Last Update
September 30 2014
Active Locations (1)
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1
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17604