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

NCT03478423 | Terminated DMC

• 1 other identifier: MSHED003
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Emergency department (ED) providers are frequently challenged with how best to treat acute pain, 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 patients discharged from the ED. Methods: This will be a blinded, randomized controlled trial of adults (age ≥ 18) 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 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.

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

• Pain Scores

  Measure the difference in pain scores assessed using the brief pain inventory (short form)

  3 days

Secondary Outcomes (3)

• Numerical Opioid Side Effects

  3 days

• Adverse Events

  3 days

• Pain Interference

  3 days

Study Arms (3)

Codeine

EXPERIMENTAL

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

Oxycodone

EXPERIMENTAL

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

Hydromorphone

EXPERIMENTAL

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

Interventions

Codeine DRUG

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.

Codeine

Oxycodone DRUG

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.

Oxycodone

Hydromorphone DRUG

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.

Also known as: Dilaudid

Hydromorphone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>=18 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Codeine; Oxycodone; Hydromorphone

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Catherine Varner, MD MSc

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Scientist

Study Record Dates

• First Submitted: February 9, 2018
• First Posted: March 27, 2018
• Study Start: February 5, 2018
• Primary Completion: September 17, 2019
• Study Completion: September 17, 2019
• Last Updated: October 2, 2019

Record last verified: 2019-09

Locations

CA (1)