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

Lancaster General Hospital

Status and phase: Withdrawn; Phase 3

Conditions: Hip Fracture; Pain

Treatments: Drug: Acetaminophen IV; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01520298

2011-52 (Other Identifier)

Details and patient eligibility

About

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.

Full 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 drug/placebo the subject's blood pressure, heart rate, respiratory rate, & pain intensity will be monitored. Additional pain meds will be given if needed. Study treatment will continue until subject is taken into the operating room; at that time the intervention will be discontinued and other pain medication will be provided. Participation in the study will end at time of discharge from the hospital. Researchers are expecting a 33% decrease in opioid use for subjects randomized to treatment group.

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

For the control group, a total of 100 mLs of 0.9% sodium chloride will be transferred to a Hospira LifeCare container and infused over 15 minutes (6.7 mL/min). A beyond use expiration of 6 hours will be placed on the container.

Treatment:

Drug: Placebo

Acetaminophen treatment

Active Comparator group

Description:

For the treatment group, a total of 100 milliliters (mLs) of acetaminophen (1000 mg) will be transferred to a Hospira LifeCare container and infused over 15 minutes (6.7 mLs/min). A beyond use expiration of 6 hours at room temperature will place on the container, as recommended by the manufacturer.

Treatment:

Drug: Acetaminophen IV