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How Much Opioids Do You Need After Your Emergency Department Visit

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ClinicalTrials.gov Identifier: NCT02799004
Recruitment Status : Completed
First Posted : June 14, 2016
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Raoul Daoust, Hopital du Sacre-Coeur de Montreal

Brief Summary:

Pain is one of the most common complaints in emergency department (ED) and is still often poorly managed. A major prospective multicenter study reported that 74% of patients that had a pain complaint at ED triage are discharged in moderate to severe pain. Accordingly, physicians frequently prescribed analgesic after discharged for these patients, and opioid is given in 29% of ED visits involving pain complaints. However, few studies evaluate pain management after ED discharge: the frequency and length of opioids prescriptions, the opioids quantity taken by the patients, are the patients relieved and satisfied by these pain treatments, what are the adverse effects associated with the use of these medications, and what are the chances of developing addiction?

The primary aim of this study is to determine the required minimal opioids prescription for patients treated for acute pain after being discharge from the ED. Secondary objectives include: 1) monitor the patients' adverse events during opioids treatment; 2) evaluate the patients' level of pain relief associated with their respective opioids treatment; 3) determine the patients' level of addiction following post-ED opioids treatments.

The design of the project is a prospective observational cohort study. A cohort of consecutive ED patients aged 18 or more with an initial pain at triage of 4 or more and discharged from the ED in less than 48 hours with a prescription of opioid will be asked to participate in the study. Patients will be excluded if there is ongoing treatment for a pre-existing chronic pain condition or if they used opioid drugs in the past year. Research nurses will contact the patients by phone at three follow-up time points (1 week, 1 month, and 3 months). Follow-up phone interviews will evaluate pain intensity as well as pain treatment satisfaction (0-10 NRS), monitor adverse events, and investigate possible opioids addiction (SOWS: subjective opioid withdrawal scale). During these interviews, the nurses will also question the patients about their daily opioids usage and if they were relieved from pain.

This study will provide the base for future guidelines regarding the prescription of opioids treatment for specific pathology encountered in ED. It will also give indications on how to adjust the treatments according to adverse events and the level of addiction experienced by patients.


Condition or disease
Acute Pain

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Study Type : Observational
Actual Enrollment : 761 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Opioid Prescription for Patient With Acute Pain After Discharge From Emergency Department: Ideal Duration for Adequate Relief, Adverse Events, and Addiction
Actual Study Start Date : June 7, 2016
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : September 30, 2018

Group/Cohort
Patients in acute pain



Primary Outcome Measures :
  1. Opioids consumption [ Time Frame: 2 weeks ]
    The number of opioids taken after ED discharge for a given pathology


Secondary Outcome Measures :
  1. Side effects [ Time Frame: 2 weeks ]
    Recorded undesirable side effect associated with post-emergency opioids treatment

  2. Pain relief [ Time Frame: 2 weeks ]
    Patients' pain relief associated with a given prescription for a specific pathology

  3. Addiction [ Time Frame: 3 months ]
    Patients opioids addiction at three month following a post-emergency prescription



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

A cohort of consecutive emergency department patients aged 18 or more treated for an acute pain diagnosis present for less than two weeks, with an initial pain at triage of 4 and more on a 0-10 points NRS and discharged with a prescription of opioids.

The study will take place in an emergency department of a tertiary (trauma specialized center) academic urban hospital with an annual census of approximately 60,000 ED visits.

Criteria

Inclusion Criteria:

  • 18 years and older
  • Pain level at 4 or greater at triage
  • Acute pain (2 weeks or less)
  • Opioids prescription at discharge

Exclusion Criteria:

  • Language barrier
  • Pregnancy
  • Treated for chronic pain
  • Hospital stay greater than 48 hours

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): NCT02799004


Locations
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Canada, Quebec
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada, H4J 1C5
Sponsors and Collaborators
Hopital du Sacre-Coeur de Montreal
Investigators
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Principal Investigator: Raoul Daoust, MD MSc Université de Montréal
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Raoul Daoust, Researcher and Associate Professor, Hopital du Sacre-Coeur de Montreal
ClinicalTrials.gov Identifier: NCT02799004    
Other Study ID Numbers: 2016-1271
First Posted: June 14, 2016    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Emergencies
Acute Pain
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations