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OpenTrials
Completed

NCT Number: NCT03375645

Montefiore Opioid and Pain 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.

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Key information

Conditions

Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Any oral opioid

Drug

Emergency department patients who receive a prescription for an oral opioid

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Acronym: MOPS

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Dec 18, 2017
Registry last updated
Feb 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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