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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01626235

Acronym

AMPED

Enrollment

843

Registered

2012-06-22

Start date

2012-07-31

Completion date

2014-03-31

Last updated

2014-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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).

Design outcomes

Primary

Measure	Time frame	Description
Clinical Outcomes of pain control measures	5 days	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.

Secondary

Measure	Time frame	Description
Satisfaction and Economic Outcomes	5 days	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.

Countries

United States

Outcome results