Acute PainNCT02799004
How Much Opioids Do You Need After Your Emergency Department Visit
An observational study of Acute Pain, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pain
- How many people
- 761 participants
- Where
- 1 siteCanada
- Study dates
- 7 Jun 2016to 30 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 18 years and older
- Pain level at 4 or greater at triage
- Acute pain (2 weeks or less)
- Opioids prescription at discharge
Who cannot join
- Language barrier
- Pregnancy
- Treated for chronic pain
- Hospital stay greater than 48 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Acute Pain
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients in acute pain | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioids consumption
The number of opioids taken after ED discharge for a given pathology
Measured: 2 weeks
Secondary outcomes (3)
Side effects
Recorded undesirable side effect associated with post-emergency opioids treatment
Measured: 2 weeks
Pain relief
Patients' pain relief associated with a given prescription for a specific pathology
Measured: 2 weeks
Addiction
Patients opioids addiction at three month following a post-emergency prescription
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study start7 Jun 2016
- Primary completion30 Sep 2017
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 761 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raoul Daoust, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Investigators
- Raoul Daoust, MD MSc, Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02799004
- Sponsor's protocol ID
- 2016-1271
- Status last verified
- May 2019
- First submitted
- 9 Jun 2016
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Daoust R, Paquet J, Cournoyer A, Piette E, Morris J, Lessard J, Lavigne G, Chauny JM. Relationship between acute pain trajectories after an emergency department visit and chronic pain: a Canadian prospective cohort study. BMJ Open. 2020 Dec 7;10(12):e040390. doi: 10.1136/bmjopen-2020-040390.
PubMed 33293313Daoust R, Paquet J, Gosselin S, Lavigne G, Cournoyer A, Piette E, Morris J, Castonguay V, Lessard J, Chauny JM. Opioid Use and Misuse Three Months After Emergency Department Visit for Acute Pain. Acad Emerg Med. 2019 Aug;26(8):847-855. doi: 10.1111/acem.13628. Epub 2019 Jul 18.
PubMed 31317619Daoust R, Paquet J, Cournoyer A, Piette E, Morris J, Lessard J, Castonguay V, Williamson D, Chauny JM. Side effects from opioids used for acute pain after emergency department discharge. Am J Emerg Med. 2020 Apr;38(4):695-701. doi: 10.1016/j.ajem.2019.06.001. Epub 2019 Jun 3.
PubMed 31182367Daoust R, Paquet J, Cournoyer A, Piette E, Morris J, Lessard J, Castonguay V, Lavigne G, Chauny JM. Acute Pain Resolution After an Emergency Department Visit: A 14-Day Trajectory Analysis. Ann Emerg Med. 2019 Aug;74(2):224-232. doi: 10.1016/j.annemergmed.2019.01.019. Epub 2019 Feb 21.
PubMed 30797575Daoust R, Paquet J, Cournoyer A, Piette E, Morris J, Gosselin S, Emond M, Lavigne G, Lee J, Chauny JM. Quantity of opioids consumed following an emergency department visit for acute pain: a Canadian prospective cohort study. BMJ Open. 2018 Sep 17;8(9):e022649. doi: 10.1136/bmjopen-2018-022649.
PubMed 30224393
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Prescription for Patient With Acute Pain After Discharge From Emergency Department: Ideal Duration for Adequate Relief, Adverse Events, and Addiction
- ClinicalTrials.gov ID
- NCT02799004
- Acronym / sponsor ID
- 2016-1271
- Conditions
- Acute Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 761 participants (actual)
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de MontrealUniversity, hospital or other
- Study start
- 7 Jun 2016 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 14 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients in acute pain | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 18 years and older
- Pain level at 4 or greater at triage
- Acute pain (2 weeks or less)
- Opioids prescription at discharge
Key exclusion criteria (4 listed)
- Language barrier
- Pregnancy
- Treated for chronic pain
- Hospital stay greater than 48 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Opioids consumption
Time frame: 2 weeks
The number of opioids taken after ED discharge for a given pathology
3 secondary outcomes
Side effects
Time frame: 2 weeks
Pain relief
Time frame: 2 weeks
Addiction
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Derived from this study: PubMed 33293313Daoust R, Paquet J, Cournoyer A, Piette E, Morris J, Lessard J, Lavigne G, Chauny JM. Relationship between acute pain trajectories after an emergency department visit and chronic pain: a Canadian prospective cohort study. BMJ Open. 2020 Dec 7;10(12):e040390. doi: 10.1136/bmjopen-2020-040390.
- Derived from this study: PubMed 31317619Daoust R, Paquet J, Gosselin S, Lavigne G, Cournoyer A, Piette E, Morris J, Castonguay V, Lessard J, Chauny JM. Opioid Use and Misuse Three Months After Emergency Department Visit for Acute Pain. Acad Emerg Med. 2019 Aug;26(8):847-855. doi: 10.1111/acem.13628. Epub 2019 Jul 18.
- Derived from this study: PubMed 31182367Daoust R, Paquet J, Cournoyer A, Piette E, Morris J, Lessard J, Castonguay V, Williamson D, Chauny JM. Side effects from opioids used for acute pain after emergency department discharge. Am J Emerg Med. 2020 Apr;38(4):695-701. doi: 10.1016/j.ajem.2019.06.001. Epub 2019 Jun 3.
- Derived from this study: PubMed 30797575Daoust R, Paquet J, Cournoyer A, Piette E, Morris J, Lessard J, Castonguay V, Lavigne G, Chauny JM. Acute Pain Resolution After an Emergency Department Visit: A 14-Day Trajectory Analysis. Ann Emerg Med. 2019 Aug;74(2):224-232. doi: 10.1016/j.annemergmed.2019.01.019. Epub 2019 Feb 21.
- Derived from this study: PubMed 30224393Daoust R, Paquet J, Cournoyer A, Piette E, Morris J, Gosselin S, Emond M, Lavigne G, Lee J, Chauny JM. Quantity of opioids consumed following an emergency department visit for acute pain: a Canadian prospective cohort study. BMJ Open. 2018 Sep 17;8(9):e022649. doi: 10.1136/bmjopen-2018-022649.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raoul Daoust, MD MSc principal investigator
Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Pain, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioids consumption (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02799004, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.