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Opioid Analgesics for Acute Fracture Pain in Older Adults Discharged From the ED

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ClinicalTrials.gov Identifier: NCT03478423
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Catherine Varner, MD, Mount Sinai Hospital, Canada

Brief Summary:

Background: Emergency department (ED) providers are frequently challenged with how best to treat acute pain in older patients, specifically when non-opioid analgesics are insufficient or contraindicated. Studies have documented older patients presenting to the ED with painful conditions are less likely to receive pain medications than younger patients, and this inadequate pain control has been associated with increased risk of delirium and longer hospital stays. Given the concerns for drug interactions, adverse side effects, over-sedation and addiction; emergency physicians often report uncertainty regarding the ideal choice of opioid analgesic in older adults. There are no guidelines informing best practice for the management of acute pain in this population.

Objective: The primary objective is to compare the efficacy of codeine, oxycodone and hydromorphone for acute fracture pain in older patients discharged from the ED.

Methods: This will be a blinded, randomized controlled trial of older adults (age ≥ 70) discharged home from the ED with acute pain secondary to an upper extremity, lower extremity, rib, pelvic or vertebral compression fracture. Patients will be randomized to receive a 3-day supply of codeine, oxycodone or hydromorphone. Patients will also be given acetaminophen. Patients will be contacted by phone or email 3 days following their ED visit. The primary outcome will be differences in pain scores at 3 days assessed using the validated Brief Pain Inventory (Short Form). Secondary outcomes will include side effects (ie: confusion, constipation), adverse events (i.e, falls, healthcare visits) and pain interference with daily activity. Patients, physicians and all research staff will be blinded to group allocation.

Importance: All analgesics (including opioids) prescribed to older adults are associated with an increased risk of adverse events. This study seeks to inform ED providers of opioid efficacy, side effects and patient-important, functional outcomes in this growing patient population.


Condition or disease Intervention/treatment Phase
Acute Pain Drug: Codeine Drug: Oxycodone Drug: Hydromorphone Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 177 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Pharmacy will prepare study drugs in opaque vials with identical labels based on a randomization scheme provided by the trial methodologist. The opaque vials will be included in sealed, sequentially numbered study packets that will be replaced as they are used. To avoid potential patient selection and allocation bias, all physicians, nurses, RAs and patients will be blinded to the randomization schedule. Study investigators will be permitted to un-blind the study medication in the event of allergic reaction, consisting of rash and/or airway compromise.
Primary Purpose: Treatment
Official Title: A Blinded, Randomized Controlled Trial of Opioid Analgesics for the Management of Acute Fracture Pain in Older Adults Discharged From the Emergency Department
Actual Study Start Date : February 5, 2018
Estimated Primary Completion Date : August 5, 2019
Estimated Study Completion Date : August 5, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Experimental: Codeine

Patients will be provided with 30mg tablets of codeine, instructed to take 1 tablet every 4 hours as needed for moderate to severe pain if you continue to have pain despite taking acetaminophen.

Patients will also receive 500mg tablets of acetaminophen with instructions to take 1-2 tablets by mouth every 8 hours as needed for pain.

Patients will also receive 17g sachets of PEG, Dissolve in 120 to 240 mL (4 to 8 ounces) of beverage and drink. Use one sachet daily as needed to prevent constipation if you are taking the opioid study drug.

Drug: Codeine
30mg tablets. Patients will be instructed to take 1 tablet every 4 hours as needed for moderate to severe pain if you continue to have pain despite taking acetaminophen.

Experimental: Oxycodone

Patients will be provided with 5mg tablets of oxycodone, instructed to take 1 tablet every 4 hours as needed for moderate to severe pain if you continue to have pain despite taking acetaminophen.

Patients will also receive 500mg tablets of acetaminophen with instructions to take 1-2 tablets by mouth every 8 hours as needed for pain.

Patients will also receive 17g sachets of PEG, Dissolve in 120 to 240 mL (4 to 8 ounces) of beverage and drink. Use one sachet daily as needed to prevent constipation if you are taking the opioid study drug.

Drug: Oxycodone
5mg tablets. Patients will be instructed to take 1 tablet every 4 hours as needed for moderate to severe pain if you continue to have pain despite taking acetaminophen.

Experimental: Hydromorphone

Patients will be provided with 1mg tablets of hydromorphone, instructed to take 1 tablet every 4 hours as needed for moderate to severe pain if you continue to have pain despite taking acetaminophen.

Patients will also receive 500mg tablets of acetaminophen with instructions to take 1-2 tablets by mouth every 8 hours as needed for pain.

Patients will also receive 17g sachets of PEG, Dissolve in 120 to 240 mL (4 to 8 ounces) of beverage and drink. Use one sachet daily as needed to prevent constipation if you are taking the opioid study drug.

Drug: Hydromorphone
1mg tablets.Patients will be instructed to take 1 tablet every 4 hours as needed for moderate to severe pain if you continue to have pain despite taking acetaminophen.
Other Name: Dilaudid




Primary Outcome Measures :
  1. Pain Scores [ Time Frame: 3 days ]
    Measure the difference in pain scores assessed using the brief pain inventory (short form)


Secondary Outcome Measures :
  1. Numerical Opioid Side Effects [ Time Frame: 3 days ]
    Side effects will be measured using a modified version of The Numerical Opioid Side Effect (NOSE) Assessment Tool during the telephone follow-up. This measures nausea, fatigue, constipation, itching, sexual desire/libido, dry mouth, abdominal pain, sweating, headache, and urinary retention on 11 point scales.

  2. Adverse Events [ Time Frame: 3 days ]
    number of falls, number of visits to healthcare providers

  3. Pain Interference [ Time Frame: 3 days ]
    Participants will be asked how pain interferes with various activities of daily living (general activity, mood, walking, normal work, relations, sleep, enjoyment of life, and "other") on 11 point scales.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • >=70 Years
  • live independently
  • acute pain secondary to an upper extremity, lower extremity, rib, pelvic or vertebral compression fracture occurring within 7 days prior to their visit
  • ED physician intends to prescribe opioid analgesic upon ED discharge

Exclusion Criteria:

  • an allergy to any of the study drug (acetaminophen, polyethylene glycol 3350, codeine, oxycodone, hydromorphone)
  • non-English speaking without an adequate interpreter
  • already on prescribed chronic opioid pain medication
  • ongoing use of sedating medications (e.g., benzodiazepines, antipsychotics)
  • current substance use disorder excluding tobacco
  • on opioid substitution therapy
  • comorbidity representing an absolute or relative contraindication to acute opioid prescribing (ie. any medical condition requiring home oxygen, Addison's disease, dialysis dependence, obstructive sleep apnea on non-invasive positive pressure ventilation, body mass index > 45, Cushing's Disease)
  • moderate to severe dementia
  • inability to follow-up
  • reside in a nursing home or location where a professional dispenses medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03478423


Contacts
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Contact: Catherine Varner, MD MSc 416-586-5959 catherine.varner@sinaihealthsystem.ca
Contact: Shelley McLeod, PhD(c) MSc 416-586-8330 shelley.mcleod@sinaihealthsystem.ca

Locations
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Canada, Ontario
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Catherine E Varner, MD    416-586-5054    CVarner@mtsinai.on.ca   
Principal Investigator: Catherine E Varner, MD         
Sponsors and Collaborators
Mount Sinai Hospital, Canada
Investigators
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Principal Investigator: Catherine Varner, MD MSc MOUNT SINAI HOSPITAL

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Responsible Party: Catherine Varner, MD, Clinician Scientist, Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT03478423     History of Changes
Other Study ID Numbers: MSHED003
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Oxycodone
Hydromorphone
Codeine
Acetaminophen
Analgesics
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Antipyretics
Antitussive Agents
Respiratory System Agents