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

• Status: Withdrawn
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lancaster General Hospital
• Treatments: Acetaminophen

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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