Improving Pain and Function in Hip Fracture

Completed · Phase 3

Conditions studied: Pain, Hip Fractures

In brief

The purpose of this study is to compare two different methods of treating pain after a hip fracture.

Key facts

Study ID

NCT00749489

Run by

Icahn School of Medicine at Mount Sinai

People needed

164

Starts

2008-11-01

Expected to finish

2014-05-01

Last updated by the study team

2014-06-25

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All adult patients 60 years of age and over that present to the MSMC ED from 8:00 to 20:00 with a radiographically confirmed hip fracture (femoral neck, intertrochanteric, or peri-capsular) will be screened for study eligibility.

You may not qualify if…

• History of advanced dementia
• Presence of multiple trauma, pathological fractures, bilateral hip fractures, or previous fracture or surgery at the currently fractured site
• Patients transferred from another hospital
• Patients with cirrhosis or liver failure.
• The investigators exclude patients with advanced dementia because the investigators will require patients to self-report their pain intensity.
• The investigators exclude these categories of hip fracture because they represent patients with atypical or often problematic clinical circumstances.
• The investigators exclude patients under age 60 because our focus is on treatment of pain in older adults. Younger adults (less than age 60) typically present with fractures of different cause (severe and multiple trauma), are less sensitive to the side effects and complications of opioid therapy, are less likely to have delayed or prolonged functional recovery, and are less sensitive to the adverse and sometimes permanent effects of prolonged bed rest (i.e., from pain) on function.
• The investigators exclude patients with hepatic dysfunction because the intervention protocol includes administration of acetaminophen which can provoke liver failure in patients with advanced liver disease.

Where it is running

• Beth Israel — New York, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Maimonides Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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