Intravenous Acetaminophen as Adjuvant Therapy for Pain Control in Geriatric Hip Fracture Patients

Withdrawn before enrolling · Phase 3 · Has a placebo group

Conditions studied: Pain, Hip Fracture

In brief

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 acetaminophen has received FDA approval. IV acetaminophen does not have the liver toxicity as oral acetaminophen. No oral acetaminophen will be administered. All patients diagnosed with a hip fracture aged at least 65 years and expected to undergo surgical intervention are eligible to participate. Hip fractures affect greater than 300,000 geriatric patients annually, representing the second leading cause of hospitalization for this patient population. Pain control in these patients is often problematic due to co-morbidities and changes in their pharmacokinetic and pharmacodynamic profiles. Subjects may receive the normal DVT prophylactic treatments post-op.

Key facts

Study ID

NCT01520298

Run by

Lancaster General Hospital

People needed

0

Starts

2011-12-01

Expected to finish

2013-05-01

Last updated by the study team

2014-09-30

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Lancaster General Hospital — Lancaster, Pennsylvania, United States

Full record on ClinicalTrials.gov

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