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| Name | Class |
|---|---|
| American Regent, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NSAID only | Subjects have their pain treated post-ED care with NSAID medication alone | ||
| Opioid only | Subjects have their pain treated post-ED care with opioid medication alone | ||
| NSAID + Opioid | Subjects have their pain treated post-ED care with NSAID medication and opioid as PRN rescue analgesia |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical Outcomes of pain control measures |
| 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction and Economic Outcomes |
| 5 days |
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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:
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at least 800 patients with specific musculoskeletal or visceral pain syndrome
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| Name | Affiliation | Role |
|---|---|---|
| Charles V Pollack, MD | University of Pennsylvania | Principal Investigator |
| Knox Todd, MD | MD Anderson | Study Director |
| Debra Diercks, MD | UC Davis | Study Director |
| Sharon Mace, MD | The Cleveland Clinic | Study Director |
| Stephen Thomas, MD | Univ Oklahoma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| LSU Medical Center |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 4, 2015 | |
| Reset | Jan 9, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 4, 2015 | Jan 9, 2015 |
| ID | Term |
|---|---|
| D017695 | Soft Tissue Injuries |
| D015210 | Arthritis, Gouty |
| D050723 | Fractures, Bone |
| D056844 | Renal Colic |
| D004412 | Dysmenorrhea |
| D000377 | Agnosia |
| D013180 | Sprains and Strains |
| D007669 | Kidney Calculi |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D006073 | Gout |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
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| New Orleans |
| Louisiana |
| 70112 |
| United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44106 | United States |
| University of Oklahoma HSC | Tulsa | Oklahoma | 74135 | United States |
| Pennsylvania Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29403 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Ben Taub General Hospital | Houston | Texas | 77030 | United States |
| University of Texas HSC at Houston | Houston | Texas | 77030 | United States |
| D009140 |
| Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
| D012216 | Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D017699 | Pelvic Pain |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D020969 | Disease Attributes |