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

NCT03478423 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2019-10-02

No results posted yet for this study

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

Interventions

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.

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.

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.

Sponsors & Collaborators

  • Mount Sinai Hospital, Canada

    lead OTHER

Principal Investigators

  • Catherine Varner, MD MSc · MOUNT SINAI HOSPITAL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-05
Primary Completion
2019-09-17
Completion
2019-09-17

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03478423 on ClinicalTrials.gov