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

• Status: Terminated
• Trial end date: 2019-09-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mount Sinai Hospital, Canada
• Treatments: Acetaminophen; Analgesics; Analgesics, Opioid; Codeine; Hydromorphone; Oxycodone

Criteria

Inclusion Criteria:

• >=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

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