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

NCT01520298 | Withdrawn Phase 3

• 1 other identifier: 2011-52
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Hip Fracture

Outcome Measures

Primary Outcomes (1)

• Opioid usage

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

  24 Hours

Secondary Outcomes (4)

• Length of stay

  Up to 1 week

• Vital signs

  Up to 1 week

• Pain scores

  Up to 1 week

• Opioid induced side effects

  Up to 1 week

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Acetaminophen treatment

ACTIVE COMPARATOR

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

Interventions

Placebo 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.

Placebo

Acetaminophen IV 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.

Acetaminophen treatment

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Lancaster General Hospital: lead

Study Sites (1)

Lancaster General Hospital

Lancaster, Pennsylvania, 17604, United States

Location

Related Publications (12)

• 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.

  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.

  PMID: 15187857 BACKGROUND

• 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.

  PMID: 12764718 BACKGROUND

• 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.

  PMID: 12791436 BACKGROUND

• 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.

  PMID: 16307627 BACKGROUND

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

  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.

  PMID: 18686750 BACKGROUND

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

  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.

  PMID: 15791113 BACKGROUND

• 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.

  PMID: 16130055 BACKGROUND

• 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.

  PMID: 15763605 BACKGROUND

• 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.

  PMID: 17643995 BACKGROUND

MeSH Terms

Conditions

Pain; Hip Fractures

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Jennifer L Costello, PharmD

  Lancaster General Hospital

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Study Record Dates

• First Submitted: January 23, 2012
• First Posted: January 27, 2012
• Study Start: December 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: September 30, 2014

Record last verified: 2014-09

Locations

US (1)