AMPED Outcomes Registry of Post-ED Pain Management

This study has been completed.
Sponsor:
Collaborator:
Luitpold Pharmaceuticals
Information provided by (Responsible Party):
Radnor Registry Research, Inc
ClinicalTrials.gov Identifier:
NCT01626235
First received: June 20, 2012
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

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


Condition
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

Resource links provided by NLM:


Further study details as provided by Radnor Registry Research, Inc:

Primary Outcome Measures:
  • Clinical Outcomes of pain control measures [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    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:
  • Satisfaction and Economic Outcomes [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 843
Study Start Date: July 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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
Study Population

at least 800 patients with specific musculoskeletal or visceral pain syndrome

Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01626235

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, Louisiana
LSU Medical Center
New Orleans, Louisiana, United States, 70112
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44106
United States, Oklahoma
University of Oklahoma HSC
Tulsa, Oklahoma, United States, 74135
United States, Pennsylvania
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Medical University of South Carolina
Charleston, South Carolina, United States, 29403
United States, Texas
Ben Taub General Hospital
Houston, Texas, United States, 77030
University of Texas HSC at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
Radnor Registry Research, Inc
Luitpold Pharmaceuticals
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
  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 11, 2014
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:
Arthritis
Dysmenorrhea
Soft Tissue Injuries
Arthritis, Gouty
Renal Colic
Joint Diseases
Musculoskeletal Diseases
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Signs and Symptoms
Wounds and Injuries
Gout
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Colic
Abdominal Pain
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on September 18, 2014