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Montefiore Opioid and Pain Study (MOPS)

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ClinicalTrials.gov Identifier: NCT03375645
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
Benjamin Friedman, 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

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 : September 2018
Estimated Study Completion Date : March 2019

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



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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03375645


Contacts
Contact: Benjamin W Friedman 7189206626 befriedm@montefiore.org

Locations
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Benjamin Friedman, MD, MS    718-920-6626    befriedm@montefiore.org   
Sponsors and Collaborators
Montefiore Medical Center

Responsible Party: Benjamin Friedman, Professor, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03375645     History of Changes
Other Study ID Numbers: 2017-8419
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: De-identified data will be made available for IRB approved studies

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Acute Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents