- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01520298
Intravenous Acetaminophen as Adjuvant Therapy for Pain Control in Geriatric Hip Fracture Patients
September 29, 2014 updated by: Michael A. Horst, PhD, MPHS, MS, Lancaster General Hospital
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Lancaster, Pennsylvania, United States, 17604
- Lancaster General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Opioid usage
Time Frame: 24 Hours
|
Participants will be assessed for opioid utilization until they go to surgery: an average of 24 hours.
|
24 Hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of stay
Time Frame: Up to 1 week
|
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
|
Up to 1 week
|
Vital signs
Time Frame: Up to 1 week
|
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
|
Up to 1 week
|
Pain scores
Time Frame: Up to 1 week
|
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
|
Up to 1 week
|
Opioid induced side effects
Time Frame: Up to 1 week
|
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
|
Up to 1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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: LouAnne Kruse, RN, Lancaster General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Baumann T, Strickland J. Pain Management. In:DiPiro JT, et al., editors. Pharmacotherpay. 7th ed. New York: McGraw-Hill;2008. 989-1002
- Ofirmev [package insert].San Diego, Ca: Cadence Pharmaceuticals; 2011
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2011
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
January 23, 2012
First Submitted That Met QC Criteria
January 24, 2012
First Posted (Estimate)
January 27, 2012
Study Record Updates
Last Update Posted (Estimate)
September 30, 2014
Last Update Submitted That Met QC Criteria
September 29, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2011-52 (CCRRC)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
-
Cairo UniversityCompletedCervical Pain | Lumbar Pain SyndromeEgypt
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States