How Much Opioids Do You Need After Your Emergency Department Visit

May 9, 2019 updated by: Raoul Daoust, Hopital du Sacre-Coeur de Montreal

Opioid Prescription for Patient With Acute Pain After Discharge From Emergency Department: Ideal Duration for Adequate Relief, Adverse Events, and Addiction

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

761

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4J 1C5
        • Hôpital du Sacré-Coeur de Montreal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Patients in acute pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioids consumption
Time Frame: 2 weeks
The number of opioids taken after ED discharge for a given pathology
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effects
Time Frame: 2 weeks
Recorded undesirable side effect associated with post-emergency opioids treatment
2 weeks
Pain relief
Time Frame: 2 weeks
Patients' pain relief associated with a given prescription for a specific pathology
2 weeks
Addiction
Time Frame: 3 months
Patients opioids addiction at three month following a post-emergency prescription
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital du Sacre-Coeur de Montreal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2016

Primary Completion (Actual)

September 30, 2017

Study Completion (Actual)

September 30, 2018

Study Registration Dates

First Submitted

June 9, 2016

First Submitted That Met QC Criteria

June 13, 2016

First Posted (Estimate)

June 14, 2016

Study Record Updates

Last Update Posted (Actual)

May 10, 2019

Last Update Submitted That Met QC Criteria

May 9, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-1271

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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