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

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.

Conditions

• Pain
• Hip Fracture

Interventions

DRUG

Placebo

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. All admixture manipulations will be completed by the pharmaceutical staff according to the chapter 797 guidelines in the U.S. Pharmacopoeia. The treatment period will begin after admission and randomization, and will continue until surgical intervention.

DRUG

Acetaminophen IV

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. All admixture manipulations will be completed by the pharmaceutical staff according to the chapter 797 guidelines in the U.S. Pharmacopoeia. The treatment period will begin after admission and randomization, and will continue until surgical intervention.

Sponsors & Collaborators

• Lancaster General Hospital

  lead OTHER

Principal Investigators

• Jennifer L Costello, PharmD · Lancaster General Hospital

• Gerald W Rothacker, MD · Lancaster General Hospital

• Jason Hall, PharmD · Lancaster General Hospital

• Jill Rebuck, PharmD · Lancaster General Hospital

• Michael A Horst, PhD · Lancaster General Hospital

• Melody Dillman, RN · Lancaster General Hospital

• Michael Gish, MD · Lancaster General Hospital

• Vincent Batista, MD · Lancaster General Hospital

• James H Carson, MD · Lancaster General Hospital

• Frank M Essis, MD · Lancaster General Hospital

• David P Hughes, MD · Lancaster General Hospital

• Heidi L Testa, RN · Lancaster General Hospital

• Kay M Knepper, RN · Lancaster General Hospital

• LouAnne Kruse, RN · Lancaster General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-12-31

Primary Completion

2013-05-31

Completion

2013-05-31

Countries

• United States

Study Locations