AMPED Outcomes Registry of Post-ED Pain Management

NCT01626235 | Completed

• 1 other identifier: RRR-LUIT-01
• Study Type: observational
• Target: 843
• Locations: 1 country
• Sites: 11

Brief Summary

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

Conditions

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

Keywords

pain control; fractures; sprains; strains; dysmenorrhea; kidney stones; gouty arthritis; opioids; NSDAIDs; Emergency Department; patient reported outcomes

Outcome Measures

Primary Outcomes (1)

• Clinical Outcomes of pain control measures

  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.

  5 days

Secondary Outcomes (1)

• Satisfaction and Economic Outcomes

  5 days

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

at least 800 patients with specific musculoskeletal or visceral pain syndrome

You may qualify if:

• Eligible subjects will meet the following criteria:
• Eligible diagnoses:
• musculoskeletal etiologies: acute extremity fractures sprains/strains acute gouty arthritis visceral etiologies: renal colic dysmenorrhea
• Age GTE 18 years;
• Decision to discharge from ED to community already made;
• Decision to give SPRIX, opioid, OR SPRIX + opioid rescue already made;
• Treating clinician deems patient appropriate for continued analgesic management as an outpatient for the next 3-5 days;
• 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.

You may not qualify if:

• Eligible subjects will meet none of the following criteria:
• Patient admitted or placed on observation status from ED;
• Patient unwilling or unable to comply with telephonic follow-up;
• Fracture that requires surgical repair (even if at a later date);
• Patient has diagnosis of any chronic pain syndrome;
• Patient already routinely takes NSAID or opioid agent;
• Treating clinician has reasonable suspicion of drug-seeking behavior or noncompliance;
• 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).

Sponsors & Collaborators

• Radnor Registry Research, Inc: lead
• American Regent, Inc.: collaborator

Study Sites (11)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

LSU Medical Center

New Orleans, Louisiana, 70112, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44106, United States

Location

University of Oklahoma HSC

Tulsa, Oklahoma, 74135, United States

Location

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Ben Taub General Hospital

Houston, Texas, 77030, United States

Location

University of Texas HSC at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Soft Tissue Injuries; Arthritis, Gouty; Fractures, Bone; Renal Colic; Dysmenorrhea; Agnosia; Sprains and Strains; Kidney Calculi; Emergencies

Condition Hierarchy (Ancestors)

Wounds and Injuries; Gout; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances; Pathologic Processes; Pelvic Pain; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Disease Attributes

Study Officials

• Charles V Pollack, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2012
• First Posted: June 22, 2012
• Study Start: July 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 12, 2014

Record last verified: 2014-03

Locations

US (11)