Dysmenorrhea Clinical Trial
— AMPEDOfficial 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
Verified date | March 2014 |
Source | Radnor Registry Research, Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Study aims to assess patient-recorded outcomes of pain control medications prescribed in the ER after visits for specific painful injuries/illnesses.
Status | Completed |
Enrollment | 843 |
Est. completion date | March 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Eligible subjects will meet the following criteria: 1. Eligible diagnoses: musculoskeletal etiologies: acute extremity fractures sprains/strains acute gouty arthritis visceral etiologies: renal colic dysmenorrhea 2. Age GTE 18 years; 3. Decision to discharge from ED to community already made; 4. Decision to give SPRIX, opioid, OR SPRIX + opioid rescue already made; 5. Treating clinician deems patient appropriate for continued analgesic management as an outpatient for the next 3-5 days; 6. 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: 1. Patient admitted or placed on observation status from ED; 2. Patient unwilling or unable to comply with telephonic follow-up; 3. Fracture that requires surgical repair (even if at a later date); 4. Patient has diagnosis of any chronic pain syndrome; 5. Patient already routinely takes NSAID or opioid agent; 6. Treating clinician has reasonable suspicion of drug-seeking behavior or noncompliance; 7. 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). |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | Ben Taub General Hospital | Houston | Texas |
United States | University of Texas HSC at Houston | Houston | Texas |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | LSU Medical Center | New Orleans | Louisiana |
United States | Pennsylvania Hospital | Philadelphia | Pennsylvania |
United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
United States | University of Oklahoma HSC | Tulsa | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
Radnor Registry Research, Inc | Luitpold Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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