Clinical trial NCT01520298: Intravenous Acetaminophen as Adjuvant Therapy for Pain Control in Geriatric Hip Fracture Patients
Official title: Intravenous Acetaminophen as Adjuvant Therapy for Pain Control in Geriatric Hip Fracture Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Pain
Hip Fracture
Lead sponsor: Lancaster General Hospital
Sponsor class: OTHER
First posted: 2012-01-27
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility 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

Primary outcomes:
measure: Opioid usage
timeFrame: 24 Hours
Secondary outcomes:
measure: Length of stay
timeFrame: Up to 1 week
measure: Vital signs
timeFrame: Up to 1 week
measure: Pain scores
timeFrame: Up to 1 week
measure: Opioid induced side effects
timeFrame: Up to 1 week
Other outcomes:
Locations:
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
Study officials:
affiliation: Lancaster General Hospital
name: Jennifer L Costello, PharmD
role: STUDY_CHAIR
affiliation: Lancaster General Hospital
name: Gerald W Rothacker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lancaster General Hospital
name: Jason Hall, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lancaster General Hospital
name: Jill Rebuck, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lancaster General Hospital
name: Michael A Horst, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lancaster General Hospital
name: Melody Dillman, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Lancaster General Hospital
name: Michael Gish, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lancaster General Hospital
name: Vincent Batista, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lancaster General Hospital
name: James H Carson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lancaster General Hospital
name: Frank M Essis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lancaster General Hospital
name: David P Hughes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lancaster General Hospital
name: Heidi L Testa, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Lancaster General Hospital
name: Kay M Knepper, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Lancaster General Hospital
name: LouAnne Kruse, RN
role: PRINCIPAL_INVESTIGATOR
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