AMPED Outcomes Registry of Post-ED Pain Management

NCT ID: NCT01626235

Last Updated: 2014-03-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 843 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2014-03-31

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.

Conditions

Soft Tissue Injuries; Gouty Arthritis; Fractures; Ureteral Colic; Dysmenorrhea

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

NSAID only

Subjects have their pain treated post-ED care with NSAID medication alone

No interventions assigned to this group

Opioid only

Subjects have their pain treated post-ED care with opioid medication alone

No interventions assigned to this group

NSAID + Opioid

Subjects have their pain treated post-ED care with NSAID medication and opioid as PRN rescue analgesia

No interventions assigned to this group

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Regent, Inc.

INDUSTRY

Sponsor Role: collaborator

Radnor Registry Research, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles V Pollack, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Knox Todd, MD

Role: STUDY_DIRECTOR

MD Anderson

Debra Diercks, MD

Role: STUDY_DIRECTOR

UC Davis

Sharon Mace, MD

Role: STUDY_DIRECTOR

The Cleveland Clinic

Stephen Thomas, MD

Role: STUDY_DIRECTOR

Univ Oklahoma

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

LSU Medical Center

New Orleans, Louisiana, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Cleveland Clinic

Cleveland, Ohio, United States

University of Oklahoma HSC

Tulsa, Oklahoma, United States

Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Ben Taub General Hospital

Houston, Texas, United States

University of Texas HSC at Houston

Houston, Texas, United States

Countries

United States

Other Identifiers

RRR-LUIT-01

Identifier Type: -

Identifier Source: org_study_id