Montefiore Opioid and Pain Study

Acute Pain Clinical Trial

— MOPS  

Official title:

Montefiore Opioid and Pain Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03375645
• Other study ID #: 2017-8419
• Status: Completed
• Start date: November 8, 2017
• Est. completion date: February 15, 2022

Study information

• Verified date: February 2022
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 462
• Est. completion date: February 15, 2022
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain

Intervention

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

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	3 item PEG score	This is a validated pain questionnaire with 3 questions	3 months and 6 months after ED discharge
Secondary	Pain description	Severe, moderate, mild or no pain	3 months and 6 months after ED discharge