Intravenous Acetaminophen as Adjuvant Therapy for Pain Control in Geriatric Hip Fracture Patients
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain, Orthopedic |
| Therapuetic Areas: | Musculoskeletal, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 3/30/2013 |
| Start Date: | December 2011 |
| End Date: | December 2013 |
| Contact: | Jennifer L Costello, PharmD |
| Email: | jlcostel@lghealth.org |
| Phone: | 717-544-5169 |
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.
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.
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
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