Montefiore Opioid and Pain Study

NCT03375645 | Completed DMC

• 1 other identifier: 2017-8419
• Study Type: observational
• Target: 462
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (2)

• 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.

  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?

  6 months

Secondary Outcomes (2)

• 3 item PEG score

  3 months and 6 months after ED discharge

• Pain description

  3 months and 6 months after ED discharge

Interventions

Any oral opioid DRUG

Emergency department patients who receive a prescription for an oral opioid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Emergency department patients who are evaluated for acute pain and are prescribed an oral opioid

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Benjamin Friedman, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: December 18, 2017
• Study Start: November 8, 2017
• Primary Completion: February 15, 2022
• Study Completion: February 15, 2022
• Last Updated: February 17, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)