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Montefiore Opioid and Pain Study (MOPS)

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. Identifier: NCT03375645
Recruitment Status : Active, not recruiting
First Posted : December 18, 2017
Last Update Posted : May 20, 2021
Information provided by (Responsible Party):
Montefiore Medical Center

Brief 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.

Condition or disease Intervention/treatment
Acute Pain Drug: Any oral opioid

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Study Type : Observational
Estimated Enrollment : 462 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Montefiore Opioid and Pain Study
Actual Study Start Date : November 8, 2017
Estimated Primary Completion Date : March 23, 2022
Estimated Study Completion Date : March 23, 2022

Intervention Details:
  • Drug: Any oral opioid
    Emergency department patients who receive a prescription for an oral opioid

Primary Outcome Measures :
  1. 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.

  2. 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?

Secondary Outcome Measures :
  1. 3 item PEG score [ Time Frame: 3 months and 6 months after ED discharge ]
    This is a validated pain questionnaire with 3 questions

  2. Pain description [ Time Frame: 3 months and 6 months after ED discharge ]
    Severe, moderate, mild or no pain

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Emergency department patients who are evaluated for acute pain and are prescribed an oral opioid

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03375645

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United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
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Principal Investigator: Benjamin Friedman, MD Montefiore Medical Center
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Responsible Party: Montefiore Medical Center Identifier: NCT03375645    
Other Study ID Numbers: 2017-8419
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: May 20, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Pain
Neurologic Manifestations
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents