AMPED Outcomes Registry of Post-ED Pain… | Clinical Trial

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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).

Treatment and study plan

Primary outcomes

Clinical Outcomes of pain control measures

Time frame: 5 days
- Change in pain score over follow-up interval;
- Healthcare resource utilization during follow-up interval;
- Patient satisfaction with therapy;
- Return to work in employed cohort.

Secondary outcomes

Satisfaction and Economic Outcomes

Time frame: 5 days
- Effectiveness of work upon return;
- Relative adverse effect profiles of three treatment regimens;
- Compliance with therapy;
- QOL at conclusion of therapy.

Sponsors and collaborators

Lead sponsor

Radnor Registry Research, Inc

Industry

Collaborators

American Regent, Inc.

Registry information

Official study 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

Acronym: AMPED

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Jun 22, 2012
Registry last updated: Mar 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed