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

June 20, 2012
March 11, 2014
July 2012
March 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01626235 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
AMPED Outcomes Registry of Post-ED Pain Management
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.

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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

at least 800 patients with specific musculoskeletal or visceral pain syndrome

  • Soft Tissue Injuries
  • Gouty Arthritis
  • Fractures
  • Ureteral Colic
  • Dysmenorrhea
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
843
March 2014
March 2014   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01626235
RRR-LUIT-01
No
Radnor Registry Research, Inc
Radnor Registry Research, Inc
Luitpold Pharmaceuticals
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
Radnor Registry Research, Inc
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP