AMPED Outcomes Registry of Post-ED Pain Management

Radnor Registry Research

Status

Completed

Conditions

Gouty Arthritis

Ureteral Colic

Soft Tissue Injuries

Dysmenorrhea

Fractures

Study type

Observational

Funder types

Industry

Identifiers

NCT01626235

RRR-LUIT-01

Details and patient eligibility

About

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

Full 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.

Enrollment

843 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).