Acute PainMOPSNCT03375645
Montefiore Opioid and Pain Study
An observational study of Acute Pain, run by Montefiore Medical Center at 1 site in United States.
Trial summary
This study will determine pain and opioid outcomes 3 \& 6 months after an emergency department visit for acute pain. This is an observational study. Patients are enrolled during an ED visit and followed by telephone 3 \& 6 months later. Opioid databases will also be reviewed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pain
- What is being tested?
- Any oral opioid
- Type of treatment
- Pill or oral medicine
- How many people
- 462 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2017to 15 Feb 2022
- 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: Emergency department patients who are evaluated for acute pain and are prescribed an oral opioid
Who may be able to join
- Adults seen in the emergency department for acute, new-onset pain, defined as: 1)localized pain duration < 10 days and 2) prior to the acute episode, the patient has not had this type of pain in the preceding six months
- Upon emergency department discharge, the patients is prescribed an opioid for pain
Who cannot join
- Any prescribed opioid use within the previous six months including methadone and buprenorphine
- Frequent use of any analgesic medication (Use of any analgesic >10 days per month prior to the onset of acute pain)
- Not available for follow-up
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
This study will determine pain and opioid outcomes 3 \& 6 months after an emergency department visit for acute pain. This is an observational study. Patients are enrolled during an ED visit and followed by telephone 3 \& 6 months later. Opioid databases will also be reviewed.
- Conditions
- Acute Pain
- Being tested
- Any oral opioid
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Any oral opioidDrug
Emergency department patients who receive a prescription for an oral opioid
What is being measured
The primary outcome is the main question the study is designed to answer.
Subsequent opioid prescription
All participants in this study received an opioid prescription at the time of discharge from the emergency department. Using a review of a prescription monitoring database, this study will determine whether participants received a subsequent prescription for an opioid medication.
Measured: 6 months
Chronic pain in the affected body part
An affirmative response to the following question: its been about 180 days since you left the ER. Have you had pain on more than 50% of these days?
Measured: 6 months
Secondary outcomes (2)
3 item PEG score
This is a validated pain questionnaire with 3 questions
Measured: 3 months and 6 months after ED discharge
Pain description
Severe, moderate, mild or no pain
Measured: 3 months and 6 months after ED discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start8 Nov 2017
- Primary completion15 Feb 2022
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- 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
- 462 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Friedman, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03375645
- Sponsor's protocol ID
- 2017-8419
- Acronym
- MOPS
- Status last verified
- Feb 2022
- First submitted
- 12 Dec 2017
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Montefiore Opioid and Pain Study
- ClinicalTrials.gov ID
- NCT03375645
- Acronym / sponsor ID
- MOPS / 2017-8419
- Conditions
- Acute Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 462 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 8 Nov 2017 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 18 Dec 2017 (actual)
- 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.
This study will determine pain and opioid outcomes 3 \& 6 months after an emergency department visit for acute pain. This is an observational study. Patients are enrolled during an ED visit and followed by telephone 3 \& 6 months later. Opioid databases will also be reviewed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Emergency department patients who are evaluated for acute pain and are prescribed an oral opioid
Key inclusion criteria (2 listed)
- Adults seen in the emergency department for acute, new-onset pain, defined as: 1)localized pain duration < 10 days and 2) prior to the acute episode, the patient has not had this type of pain in the preceding six months
- Upon emergency department discharge, the patients is prescribed an opioid for pain
Key exclusion criteria (3 listed)
- Any prescribed opioid use within the previous six months including methadone and buprenorphine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Any oral opioidEmergency department patients who receive a prescription for an oral opioid | Drug | – |
Primary outcome
Subsequent opioid prescription
Time frame: 6 months
All participants in this study received an opioid prescription at the time of discharge from the emergency department. Using a review of a prescription monitoring database, this study will determine whether participants received a subsequent prescription for an opioid medication.
Chronic pain in the affected body part
Time frame: 6 months
An affirmative response to the following question: its been about 180 days since you left the ER. Have you had pain on more than 50% of these days?
2 secondary outcomes
3 item PEG score
Time frame: 3 months and 6 months after ED discharge
Pain description
Time frame: 3 months and 6 months after ED discharge
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 17 Feb 2022.
- 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.
Benjamin Friedman, MD principal investigator
Montefiore Medical Center
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 Montefiore Medical Center at 1 site in United States.
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 2 inclusion and 3 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 17 Feb 2022. 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 United States. 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?
Subsequent opioid prescription (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2022.