AMPED Outcomes Registry of Post-ED Pain Management

Study Overview
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Brief Summary
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Study aims to assess patient-recorded outcomes of pain control medications prescribed in the ER after visits for specific painful injuries/illnesses.

Detailed Description
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Multicenter, observational, prospective, out-of-hospital registry collecting clinical, satisfaction, quality of life, and healthcare resource utilization from subjects discharged after ED care for a specific acute pain syndrome with a clinician-determined analgesic regimen. Subjects are stratified by diagnosis and by regimen based on the treating clinician's judgment. The registry study is independent of ED care and clinician's decision-making.

Official Title
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Acute Management of Pain From the Emergency Department: A National, Emergency Department-Based Prospective Post-Intervention Registry of Non-Opioid and Opioid Management of Acute Pain

Conditions
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Soft Tissue Injuries, Gouty Arthritis, Fractures, Ureteral Colic, Dysmenorrhea

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible subjects will meet the following criteria: Eligible diagnoses: musculoskeletal etiologies: acute extremity fractures sprains/strains acute gouty arthritis visceral etiologies: renal colic dysmenorrhea Age GTE 18 years; Decision to discharge from ED to community already made; Decision to give SPRIX, opioid, OR SPRIX + opioid rescue already made; Treating clinician deems patient appropriate for continued analgesic management as an outpatient for the next 3-5 days; Patient has ready touch-tone (mobile or land line) telephone access, provides number (and back-up number, if possible) and agrees (verbal or written consent as mandated by site) to answer and comply with brief IVR questionnaires daily for next 4 days. Exclusion Criteria: Eligible subjects will meet none of the following criteria: Patient admitted or placed on observation status from ED; Patient unwilling or unable to comply with telephonic follow-up; Fracture that requires surgical repair (even if at a later date); Patient has diagnosis of any chronic pain syndrome; Patient already routinely takes NSAID or opioid agent; Treating clinician has reasonable suspicion of drug-seeking behavior or noncompliance; Nasal abnormality or illness that could affect the absorption of intranasal medication (such as: nasal discharge, rhinitis, acute upper respiratory infection, acute epistaxis, nasal polyp, nasal tumor).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NSAID only<br>Subjects have their pain treated post-ED care with NSAID medication alone | |
| Opioid only<br>Subjects have their pain treated post-ED care with opioid medication alone | |
| NSAID + Opioid<br>Subjects have their pain treated post-ED care with NSAID medication and opioid as PRN rescue analgesia | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Outcomes of pain control measures | Change in pain score over follow-up interval; Healthcare resource utilization during follow-up interval; Patient satisfaction with therapy; Return to work in employed cohort. | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction and Economic Outcomes | Effectiveness of work upon return; Relative adverse effect profiles of three treatment regimens; Compliance with therapy; QOL at conclusion of therapy. | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain control, fractures, strains, dysmenorrhea, kidney stones, gouty arthritis, opioids, NSDAIDs, Emergency Department, patient reported outcomes, sprains