AMPED Outcomes Registry of Post-ED Pain Management

Dysmenorrhea Clinical Trial

— AMPED  

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 Trial Details — Status: Completed

Administrative data

• NCT number: NCT01626235
• Other study ID #: RRR-LUIT-01
• Status: Completed
• Phase: N/A
• First received: June 20, 2012
• Last updated: March 11, 2014
• Start date: July 2012
• Est. completion date: March 2014

Study information

• Verified date: March 2014
• Source: Radnor Registry Research, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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).

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Gouty
• Dysmenorrhea
• Fractures
• Gouty Arthritis
• Renal Colic
• Soft Tissue Injuries
• Ureteral Colic

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Radnor Registry Research, Inc	Luitpold Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

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