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

NCT ID: NCT01520298

Last Updated: 2014-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-05-31

Brief Summary

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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

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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.

Conditions

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Pain Hip Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

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.

Group Type ACTIVE_COMPARATOR

Acetaminophen IV

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lancaster General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Michael A. Horst, PhD, MPHS, MS

Director of Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer L Costello, PharmD

Role: STUDY_CHAIR

Lancaster General Hospital

Gerald W Rothacker, MD

Role: PRINCIPAL_INVESTIGATOR

Lancaster General Hospital

Jason Hall, PharmD

Role: PRINCIPAL_INVESTIGATOR

Lancaster General Hospital

Jill Rebuck, PharmD

Role: PRINCIPAL_INVESTIGATOR

Lancaster General Hospital

Michael A Horst, PhD

Role: PRINCIPAL_INVESTIGATOR

Lancaster General Hospital

Melody Dillman, RN

Role: PRINCIPAL_INVESTIGATOR

Lancaster General Hospital

Michael Gish, MD

Role: PRINCIPAL_INVESTIGATOR

Lancaster General Hospital

Vincent Batista, MD

Role: PRINCIPAL_INVESTIGATOR

Lancaster General Hospital

James H Carson, MD

Role: PRINCIPAL_INVESTIGATOR

Lancaster General Hospital

Frank M Essis, MD

Role: PRINCIPAL_INVESTIGATOR

Lancaster General Hospital

David P Hughes, MD

Role: PRINCIPAL_INVESTIGATOR

Lancaster General Hospital

Heidi L Testa, RN

Role: PRINCIPAL_INVESTIGATOR

Lancaster General Hospital

Kay M Knepper, RN

Role: PRINCIPAL_INVESTIGATOR

Lancaster General Hospital

LouAnne Kruse, RN

Role: PRINCIPAL_INVESTIGATOR

Lancaster General Hospital

Locations

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Lancaster General Hospital

Lancaster, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 15187857 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12764718 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12791436 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16307627 (View on PubMed)

Baumann T, Strickland J. Pain Management. In:DiPiro JT, et al., editors. Pharmacotherpay. 7th ed. New York: McGraw-Hill;2008. 989-1002

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 18686750 (View on PubMed)

Ofirmev [package insert].San Diego, Ca: Cadence Pharmaceuticals; 2011

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 15791113 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16130055 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15763605 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17643995 (View on PubMed)

Other Identifiers

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2011-52

Identifier Type: -

Identifier Source: org_study_id