AMPED Outcomes Registry of Post-ED Pain Management

Completed

• Conditions: Soft Tissue Injuries; Gouty Arthritis; Fractures; Ureteral Colic; Dysmenorrhea

• Registration Number: NCT01626235
• Lead Sponsor: Radnor Registry Research, Inc

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2012-06-20
• Study First Submitted QC: 2012-06-21
• Study First Posted: 2012-06-22
• Study Start: 2012-07
• Status Verified: 2014-03
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Last Update Submitted: 2014-03-11
• Last Update Posted: 2014-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 843

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Outcomes of pain control measures	5 days	1. Change in pain score over follow-up interval; 2. Healthcare resource utilization during follow-up interval; 3. Patient satisfaction with therapy; 4. Return to work in employed cohort.

Secondary Outcome Measures

Name	Time	Method
Satisfaction and Economic Outcomes	5 days	1. Effectiveness of work upon return; 2. Relative adverse effect profiles of three treatment regimens; 3. Compliance with therapy; 4. QOL at conclusion of therapy.

Trial Locations

Locations (10)

University of Texas HSC at Houston; 🇺🇸 Houston, Texas, United States

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of Oklahoma HSC; 🇺🇸 Tulsa, Oklahoma, United States

Pennsylvania Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

LSU Medical Center; 🇺🇸 New Orleans, Louisiana, United States

Ben Taub General Hospital; 🇺🇸 Houston, Texas, United States

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States