How Much Opioids Do You Need After Your Emergency Department Visit

Acute Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02799004
• Other study ID #: 2016-1271
• Status: Completed
• Start date: June 7, 2016
• Est. completion date: September 30, 2018

Study information

• Verified date: May 2019
• Source: Hopital du Sacre-Coeur de Montreal
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 761
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Emergencies

Locations

Country	Name	City	State
Canada	Hopital du Sacre-Coeur de Montreal	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Hopital du Sacre-Coeur de Montreal

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioids consumption	The number of opioids taken after ED discharge for a given pathology	2 weeks
Secondary	Side effects	Recorded undesirable side effect associated with post-emergency opioids treatment	2 weeks
Secondary	Pain relief	Patients' pain relief associated with a given prescription for a specific pathology	2 weeks
Secondary	Addiction	Patients opioids addiction at three month following a post-emergency prescription	3 months