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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03375645
Other study ID # 2017-8419
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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