Montefiore Opioid and Pain Study

Completed

• Conditions: Acute Pain

• Registration Number: NCT03375645
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-08
• Study First Submitted: 2017-12-12
• Study First Submitted QC: 2017-12-14
• Study First Posted: 2017-12-18
• Status Verified: 2022-02
• Primary Completion: 2022-02-15
• Study Completion: 2022-02-15
• Last Update Submitted: 2022-02-16
• Last Update Posted: 2022-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 462

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Chronic pain in the affected body part	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?
Subsequent opioid prescription	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.

Secondary Outcome Measures

Name	Time	Method
Pain description	3 months and 6 months after ED discharge	Severe, moderate, mild or no pain
3 item PEG score	3 months and 6 months after ED discharge	This is a validated pain questionnaire with 3 questions

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States