AMPED Outcomes Registry of Post-ED Pain Management
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Purpose
Study aims to assess patient-recorded outcomes of pain control medications prescribed in the ER after visits for specific painful injuries/illnesses.
| Condition |
|---|
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Soft Tissue Injuries Gouty Arthritis Fractures Ureteral Colic Dysmenorrhea |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | 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 |
- Clinical Outcomes of pain control measures [ Time Frame: 5 days ] [ Designated as safety issue: No ]
- 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.
- Satisfaction and Economic Outcomes [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
- Effectiveness of work upon return;
- Relative adverse effect profiles of three treatment regimens;
- Compliance with therapy;
- QOL at conclusion of therapy.
| Estimated Enrollment: | 1000 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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NSAID only
Subjects have their pain treated post-ED care with NSAID medication alone
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Opioid only
Subjects have their pain treated post-ED care with opioid medication alone
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NSAID + Opioid
Subjects have their pain treated post-ED care with NSAID medication and opioid as PRN rescue analgesia
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Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
1,000 patients with specific musculoskeletal or visceral pain syndrome
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).
Contacts and Locations| Contact: Charles V Pollack, MD | 2158297549 | amped.study@gmail.com |
| United States, Louisiana | |
| LSU Medical Center | Recruiting |
| New Orleans, Louisiana, United States, 70112 | |
| Contact: Lisa Moreno-Walton, MD doctormoreno@gmail.com | |
| Principal Investigator: Lisa Moreno-Walton, MD | |
| United States, Mississippi | |
| University of Mississippi Medical Center | Recruiting |
| Jackson, Mississippi, United States, 39216 | |
| Contact: James Thompson, MD | |
| Principal Investigator: James Thompson, MD | |
| United States, Ohio | |
| Cleveland Clinic | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Sharon Mace, MD | |
| Principal Investigator: Sharon Mace, MD | |
| United States, Oklahoma | |
| University of Oklahoma HSC | Recruiting |
| Tulsa, Oklahoma, United States, 74135 | |
| Contact: Stephen Thomas, MD stephen-thomas@ouhsc.edu | |
| Principal Investigator: Stephen Thomas, MD | |
| United States, Pennsylvania | |
| Pennsylvania Hospital | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: Charles V Pollack, MD 215-829-7549 pollackc@pahosp.com | |
| Principal Investigator: Charles V Pollack, MD | |
| Thomas Jefferson University Hospital | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: Bernard Lopez, MD | |
| Principal Investigator: Bernard Lopez, MD | |
| United States, South Carolina | |
| Medical University of South Carolina | Recruiting |
| Charleston, South Carolina, United States, 29425 | |
| Contact: Gary Headden, MD headdeng@musc.edu | |
| Principal Investigator: Gary Headden, MD | |
| Medical University of South Carolina | Recruiting |
| Charleston, South Carolina, United States, 29403 | |
| Contact: Gary Headden, MD | |
| Principal Investigator: Gary Headden, MD | |
| United States, Texas | |
| Ben Taub General Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Zubaid Rafique, MD | |
| Principal Investigator: Zubaid Rafique, MD | |
| University of Texas HSC at Houston | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Carlos Roldan, MD | |
| Principal Investigator: Carlos Roldan, MD | |
| Principal Investigator: | Charles V Pollack, MD | University of Pennsylvania |
| Study Director: | 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 |
More Information
No publications provided
| Responsible Party: | Radnor Registry Research, Inc |
| ClinicalTrials.gov Identifier: | NCT01626235 History of Changes |
| Other Study ID Numbers: | RRR-LUIT-01 |
| Study First Received: | June 20, 2012 |
| Last Updated: | March 22, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Radnor Registry Research, Inc:
|
pain control fractures sprains strains dysmenorrhea kidney stones |
gouty arthritis opioids NSDAIDs Emergency Department patient reported outcomes |
Additional relevant MeSH terms:
|
Renal Colic Colic Arthritis Arthritis, Gouty Dysmenorrhea Fractures, Bone Soft Tissue Injuries Joint Diseases Musculoskeletal Diseases Gout Rheumatic Diseases Purine-Pyrimidine Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn Metabolic Diseases |
Menstruation Disturbances Pathologic Processes Pelvic Pain Pain Signs and Symptoms Wounds and Injuries Abdominal Pain Signs and Symptoms, Digestive Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 22, 2013