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
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|
|Study Type :||Observational|
|Actual Enrollment :||761 participants|
|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|
|Patients in acute pain|
- Opioids consumption [ Time Frame: 2 weeks ]The number of opioids taken after ED discharge for a given pathology
- 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
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
|Hopital du Sacre-Coeur de Montreal|
|Montreal, Quebec, Canada, H4J 1C5|
|Principal Investigator:||Raoul Daoust, MD MSc||Université de Montréal|