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

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ClinicalTrials.gov Identifier: NCT01626235
Recruitment Status : Completed
First Posted : June 22, 2012
Last Update Posted : March 12, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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

Condition or disease
Soft Tissue Injuries Gouty Arthritis Fractures Ureteral Colic Dysmenorrhea

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 Design

Study Type : Observational
Actual Enrollment : 843 participants
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
Study Start Date : July 2012
Primary Completion Date : March 2014
Study Completion Date : March 2014
Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. Clinical Outcomes of pain control measures [ Time Frame: 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 :
  1. Satisfaction and Economic Outcomes [ Time Frame: 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, 29403
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
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

Responsible Party: Radnor Registry Research, Inc
ClinicalTrials.gov Identifier: NCT01626235     History of Changes
Other Study ID Numbers: RRR-LUIT-01
First Posted: June 22, 2012    Key Record Dates
Last Update Posted: March 12, 2014
Last Verified: March 2014

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
Neurologic Manifestations
Signs and Symptoms
Wounds and Injuries
Gout
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Nervous System Diseases
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents