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How Much Opioids Do You Need After Your Emergency Department Visit

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date June 9, 2016
First Posted Date June 14, 2016
Last Update Posted Date May 10, 2019
Actual Study Start Date June 7, 2016
Actual Primary Completion Date September 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 13, 2016)
Opioids consumption [ Time Frame: 2 weeks ]
The number of opioids taken after ED discharge for a given pathology
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 13, 2016)
  • Side effects [ Time Frame: 2 weeks ]
    Recorded undesirable side effect associated with post-emergency opioids treatment
  • Pain relief [ Time Frame: 2 weeks ]
    Patients' pain relief associated with a given prescription for a specific pathology
  • Addiction [ Time Frame: 3 months ]
    Patients opioids addiction at three month following a post-emergency prescription
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title How Much Opioids Do You Need After Your Emergency Department Visit
Official Title Opioid Prescription for Patient With Acute Pain After Discharge From Emergency Department: Ideal Duration for Adequate Relief, Adverse Events, and Addiction
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition Acute Pain
Intervention Not Provided
Study Groups/Cohorts Patients in acute pain
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 23, 2018)
761
Original Estimated Enrollment
 (submitted: June 13, 2016)
1200
Actual Study Completion Date September 30, 2018
Actual Primary Completion Date September 30, 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT02799004
Other Study ID Numbers 2016-1271
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Raoul Daoust, Hopital du Sacre-Coeur de Montreal
Original Responsible Party Same as current
Current Study Sponsor Hopital du Sacre-Coeur de Montreal
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Raoul Daoust, MD MSc Université de Montréal
PRS Account Hopital du Sacre-Coeur de Montreal
Verification Date May 2019