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

This study has been terminated.
(Difficulty in recruiting subjects for the trial.)
Sponsor:
Information provided by (Responsible Party):
Michael A. Horst, PhD, MPHS, MS, Lancaster General Hospital
ClinicalTrials.gov Identifier:
NCT01520298
First received: January 23, 2012
Last updated: May 22, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Pain
Hip Fracture
Drug: Placebo
Drug: Acetaminophen IV
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intravenous Acetaminophen as Adjuvant Therapy for Pain Control in Geriatric Hip Fracture Patients

Resource links provided by NLM:


Further study details as provided by Lancaster General Hospital:

Primary Outcome Measures:
  • Opioid usage [ Time Frame: 24 Hours ] [ Designated as safety issue: No ]
    Participants will be assessed for opioid utilization until they go to surgery: an average of 24 hours.


Secondary Outcome Measures:
  • Length of stay [ Time Frame: Up to 1 week ] [ Designated as safety issue: No ]
    Participants will be followed for the duration of their hospital stay, an expected average of 1 week. Length of stay, vital signs (blood pressure, heart rate, respiratory rate), pain scores using the visual analog scale (VAS), and opioid induced side effects including: nausea, vomiting, changes in blood pressure and delirium

  • Vital signs [ Time Frame: Up to 1 week ] [ Designated as safety issue: No ]
    Participants will be followed for the duration of their hospital stay, an expected average of 1 week. Length of stay, vital signs (blood pressure, heart rate, respiratory rate), pain scores using the visual analog scale (VAS), and opioid induced side effects including: nausea, vomiting, changes in blood pressure and delirium

  • Pain scores [ Time Frame: Up to 1 week ] [ Designated as safety issue: No ]
    Participants will be followed for the duration of their hospital stay, an expected average of 1 week. Length of stay, vital signs (blood pressure, heart rate, respiratory rate), pain scores using the visual analog scale (VAS), and opioid induced side effects including: nausea, vomiting, changes in blood pressure and delirium

  • Opioid induced side effects [ Time Frame: Up to 1 week ] [ Designated as safety issue: No ]
    Participants will be followed for the duration of their hospital stay, an expected average of 1 week. Length of stay, vital signs (blood pressure, heart rate, respiratory rate), pain scores using the visual analog scale (VAS), and opioid induced side effects including: nausea, vomiting, changes in blood pressure and delirium


Enrollment: 2
Study Start Date: December 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 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.
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.
Active Comparator: Acetaminophen treatment
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.
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.

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01520298

Locations
United States, Pennsylvania
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17604
Sponsors and Collaborators
Lancaster General Hospital
Investigators
Study Chair: Jennifer L Costello, PharmD Lancaster General Hospital
Principal Investigator: Gerald W Rothacker, MD Lancaster General Hospital
Principal Investigator: Jason Hall, PharmD Lancaster General Hospital
Principal Investigator: Jill Rebuck, PharmD Lancaster General Hospital
Principal Investigator: Michael A Horst, PhD Lancaster General Hospital
Principal Investigator: Melody Dillman, RN Lancaster General Hospital
Principal Investigator: Michael Gish, MD Lancaster General Hospital
Principal Investigator: Vincent Batista, MD Lancaster General Hospital
Principal Investigator: James H Carson, MD Lancaster General Hospital
Principal Investigator: Frank M Essis, MD Lancaster General Hospital
Principal Investigator: David P Hughes, MD Lancaster General Hospital
Principal Investigator: Heidi L Testa, RN Lancaster General Hospital
Principal Investigator: Kay M Knepper, RN Lancaster General Hospital
Principal Investigator: LouAnne Kruse, RN Lancaster General Hospital
  More Information

Publications:

Responsible Party: Michael A. Horst, PhD, MPHS, MS, Director of Research, Lancaster General Hospital
ClinicalTrials.gov Identifier: NCT01520298     History of Changes
Other Study ID Numbers: 2011-52
Study First Received: January 23, 2012
Last Updated: May 22, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Acetaminophen
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014