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.
Brief Title
Montefiore Opioid and Pain Study
Categories
Completion Date
Completion Date Type
Actual
Conditions
Acute Pain
Eligibility Criteria
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
* 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
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03375645
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2017-8419
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Montefiore Opioid and Pain Study
Primary Outcomes
Outcome Description
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.
Outcome Measure
Subsequent opioid prescription
Outcome Time Frame
6 months
Outcome Description
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?
Outcome Measure
Chronic pain in the affected body part
Outcome Time Frame
6 months
Secondary Outcomes
Outcome Description
This is a validated pain questionnaire with 3 questions
Outcome Time Frame
3 months and 6 months after ED discharge
Outcome Measure
3 item PEG score
Outcome Description
Severe, moderate, mild or no pain
Outcome Time Frame
3 months and 6 months after ED discharge
Outcome Measure
Pain description
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Emergency department patients who are evaluated for acute pain and are prescribed an oral opioid
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Benjamin Friedman
Investigator Email
befriedm@montefiore.org
Investigator Phone
646-265-6415