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

Primary Purpose

Pain, Hip Fracture

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Placebo
Acetaminophen IV
Sponsored by
Lancaster General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lancaster General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Acetaminophen treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Opioid usage
Participants will be assessed for opioid utilization until they go to surgery: an average of 24 hours.

Secondary Outcome Measures

Length of stay
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
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
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
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

Full Information

First Posted
January 23, 2012
Last Updated
September 29, 2014
Sponsor
Lancaster General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01520298
Brief Title
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

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Difficulty in recruiting subjects for the trial.
Study Start Date
December 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lancaster General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Hip Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Acetaminophen treatment
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Acetaminophen IV
Intervention Description
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.
Primary Outcome Measure Information:
Title
Opioid usage
Description
Participants will be assessed for opioid utilization until they go to surgery: an average of 24 hours.
Time Frame
24 Hours
Secondary Outcome Measure Information:
Title
Length of stay
Description
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
Time Frame
Up to 1 week
Title
Vital signs
Description
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
Time Frame
Up to 1 week
Title
Pain scores
Description
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
Time Frame
Up to 1 week
Title
Opioid induced side effects
Description
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
Time Frame
Up to 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer L Costello, PharmD
Organizational Affiliation
Lancaster General Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gerald W Rothacker, MD
Organizational Affiliation
Lancaster General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jason Hall, PharmD
Organizational Affiliation
Lancaster General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jill Rebuck, PharmD
Organizational Affiliation
Lancaster General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael A Horst, PhD
Organizational Affiliation
Lancaster General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Melody Dillman, RN
Organizational Affiliation
Lancaster General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Gish, MD
Organizational Affiliation
Lancaster General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vincent Batista, MD
Organizational Affiliation
Lancaster General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James H Carson, MD
Organizational Affiliation
Lancaster General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frank M Essis, MD
Organizational Affiliation
Lancaster General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David P Hughes, MD
Organizational Affiliation
Lancaster General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Heidi L Testa, RN
Organizational Affiliation
Lancaster General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kay M Knepper, RN
Organizational Affiliation
Lancaster General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
LouAnne Kruse, RN
Organizational Affiliation
Lancaster General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lancaster General Hospital
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Abbott C. Falls and hip fractures [updated: February 2011]. University of Missouri-Columbia School of Health Professions. Available at: http://www.vhct.org/case4007/index.htm. Accessed September 26, 2011.
Results Reference
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PubMed Identifier
15187857
Citation
Edelstein DM, Aharonoff GB, Karp A, Capla EL, Zuckerman JD, Koval KJ. Effect of postoperative delirium on outcome after hip fracture. Clin Orthop Relat Res. 2004 May;(422):195-200. doi: 10.1097/01.blo.0000128649.59959.0c.
Results Reference
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PubMed Identifier
12764718
Citation
Schuurmans MJ, Duursma SA, Shortridge-Baggett LM, Clevers GJ, Pel-Littel R. Elderly patients with a hip fracture: the risk for delirium. Appl Nurs Res. 2003 May;16(2):75-84. doi: 10.1016/s0897-1897(03)00012-0.
Results Reference
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PubMed Identifier
12791436
Citation
Morrison SR, Magaziner J, McLaughlin MA, Orosz G, Silberzweig SB, Koval KJ, Siu AL. The impact of post-operative pain on outcomes following hip fracture. Pain. 2003 Jun;103(3):303-311. doi: 10.1016/S0304-3959(02)00458-X.
Results Reference
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PubMed Identifier
16307627
Citation
Beaupre LA, Jones CA, Saunders LD, Johnston DW, Buckingham J, Majumdar SR. Best practices for elderly hip fracture patients. A systematic overview of the evidence. J Gen Intern Med. 2005 Nov;20(11):1019-25. doi: 10.1111/j.1525-1497.2005.00219.x.
Results Reference
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Citation
Baumann T, Strickland J. Pain Management. In:DiPiro JT, et al., editors. Pharmacotherpay. 7th ed. New York: McGraw-Hill;2008. 989-1002
Results Reference
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PubMed Identifier
18686750
Citation
Chau DL, Walker V, Pai L, Cho LM. Opiates and elderly: use and side effects. Clin Interv Aging. 2008;3(2):273-8. doi: 10.2147/cia.s1847.
Results Reference
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Citation
Ofirmev [package insert].San Diego, Ca: Cadence Pharmaceuticals; 2011
Results Reference
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PubMed Identifier
15791113
Citation
Sinatra RS, Jahr JS, Reynolds LW, Viscusi ER, Groudine SB, Payen-Champenois C. Efficacy and safety of single and repeated administration of 1 gram intravenous acetaminophen injection (paracetamol) for pain management after major orthopedic surgery. Anesthesiology. 2005 Apr;102(4):822-31. doi: 10.1097/00000542-200504000-00019.
Results Reference
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PubMed Identifier
16130055
Citation
Pettersson PH, Jakobsson J, Owall A. Intravenous acetaminophen reduced the use of opioids compared with oral administration after coronary artery bypass grafting. J Cardiothorac Vasc Anesth. 2005 Jun;19(3):306-9. doi: 10.1053/j.jvca.2005.03.006.
Results Reference
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Citation
Singla N, Pong A, Newman K; MD-10 Study Group. Combination oxycodone 5 mg/ibuprofen 400 mg for the treatment of pain after abdominal or pelvic surgery in women: a randomized, double-blind, placebo- and active-controlled parallel-group study. Clin Ther. 2005 Jan;27(1):45-57. doi: 10.1016/j.clinthera.2005.01.010.
Results Reference
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Citation
Cattabriga I, Pacini D, Lamazza G, Talarico F, Di Bartolomeo R, Grillone G, Bacchi-Reggiani L. Intravenous paracetamol as adjunctive treatment for postoperative pain after cardiac surgery: a double blind randomized controlled trial. Eur J Cardiothorac Surg. 2007 Sep;32(3):527-31. doi: 10.1016/j.ejcts.2007.05.017. Epub 2007 Jul 23.
Results Reference
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Intravenous Acetaminophen as Adjuvant Therapy for Pain Control in Geriatric Hip Fracture Patients

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