AMPED Outcomes Registry of Post-ED Pain Management (AMPED)

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

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

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 843

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • LSU Medical Center
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Cleveland Clinic
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74135
      • University of Oklahoma HSC
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital
    • Philadelphia, Pennsylvania, United States, 19107
      • Pennsylvania Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Charleston, South Carolina, United States, 29403
      • Medical University of South Carolina
  • Texas
    • Houston, Texas, United States, 77030
      • Ben Taub General Hospital
    • Houston, Texas, United States, 77030
      • University of Texas HSC at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

at least 800 patients with specific musculoskeletal or visceral pain syndrome

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Radnor Registry Research, Inc
• Collaborators: American Regent, Inc.
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: June 20, 2012
• First Submitted That Met QC Criteria: June 21, 2012
• First Posted (Estimate): June 22, 2012

Study Record Updates

• Last Update Posted (Estimate): March 12, 2014
• Last Update Submitted That Met QC Criteria: March 11, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Emergency Department; fractures; kidney stones; opioids; patient reported outcomes; pain control; gouty arthritis; dysmenorrhea; sprains; strains; NSDAIDs
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Metabolism, Inborn Errors; Menstruation Disturbances; Pelvic Pain; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Gout; Renal Colic; Arthritis; Soft Tissue Injuries; Dysmenorrhea; Arthritis, Gouty
• Other Study ID Numbers: RRR-LUIT-01